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Clinical Trial Details

Trial ID: L3298
Source ID: NCT02607865
Associated Drug: Semaglutide
Title: Efficacy and Long-term Safety of Oral Semaglutide Versus Sitagliptin in Subjects With Type 2 Diabetes
Acronym: PIONEER 3
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02607865/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: sitagliptin|DRUG: placebo
Outcome Measures: Primary: Change in HbA1c: Week 26, Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Week 0, week 26 | Secondary: Change in Body Weight: Week 26, Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Week 0, week 26|Change in HbA1c: Weeks 52 and 78, Change from baseline (week 0) in HbA1c was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 52, week 78|Change in Body Weight (kg): Weeks 52 and 78, Change from baseline (week 0) in body weight was evaluated at weeks 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 52, week 78|Change in Body Weight (%), Relative change from baseline (week 0) in body weight (kg) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in FPG, Change from baseline (week 0) in fasting plasma glucose (FPG) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in BMI, Change from baseline (week 0) in body mass index (BMI) was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in Waist Circumference, Change from baseline (week 0) in waist circumference was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in Total Cholesterol (Ratio to Baseline), Change from baseline (week 0) in total cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in LDL Cholesterol (Ratio to Baseline), Change from baseline (week 0) in low-density lipoprotein (LDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in VLDL Cholesterol (Ratio to Baseline), Change from baseline (week 0) in very-low-density lipoprotein (VLDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in HDL Cholesterol (Ratio to Baseline), Change from baseline (week 0) in high-density lipoprotein (HDL) cholesterol (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in Triglycerides (Ratio to Baseline), Change from baseline (week 0) in triglycerides (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in Free Fatty Acids (Ratio to Baseline), Change from baseline (week 0) in free fatty acids (FFA) (mmol/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Because of an issue with the handling of the blood samples for FFA, all FFA data were considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the data presented here., Week 0, week 26, week 52, week 78|Change in SMPG - Mean 7-point Profile, Change from baseline (week 0) in mean 7-point self-measured plasma glucose (SMPG) profile. SMPG was recorded at the following 7 time points: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after dinner and at bedtime. Mean 7-point profile was defined as the area under the profile, calculated using the trapezoidal method, divided by the measurement time. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in SMPG - Mean Postprandial Increment Over All Meals, Change from baseline (week 0) in the average of the post-prandial increments over all meals was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no), Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at weeks 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 26, week 52, week 78|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol) AACE Target (Yes/no), Participants who achieved HbA1c less than or equal to 6.5% (American Association of Clinical Endocrinologists (AACE) target) (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 26, week 52, week 78|Participants Who Achieve Weight Loss ≥5% (Yes/no), Participants who achieved weight loss more than or equal to 5% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 26, week 52, week 78|Participants Who Achieve Weight Loss ≥10% (Yes/no), Participants who achieved weight loss more than or equal to 10% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 26, week 52, week 78|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) Without Hypoglycaemia (Severe or BG Confirmed Symptomatic Hypoglycaemia) and no Weight Gain (Yes/no), Participants who achieved HbA1c less than 7.0 % without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain (yes/no) at weeks 26, 52 and 78 are presented. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia was defined as an episode with plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 26, week 52, week 78|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no), Participants who achieved HbA1c reduction more than or equal to 1% of their baseline HbA1c and weight loss of more than or equal to 3% of their baseline body weight (yes/no) at weeks 26, 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 26, week 52, week 78|Time to Additional Anti-diabetic Medication, Presented results are the number of participants who had taken additional anti-diabetic medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Additional anti-diabetic medication was defined as any new anti-diabetic medication used for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 78), and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before (planned) end-of-treatment. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Weeks 0-78|Time to Rescue Medication, Presented results are the number of participants who had taken rescue medication anytime during the periods, from week 0 to week 26, week 0 to week 52 and week 0 to week 78. Rescue medication was defined as any new anti-diabetic medication used as add-on to trial product and used for more than 21 days with the initiation at or after randomisation (week 0) and before last day on trial product, and/or intensification of anti-diabetic medication (a more than 20% increase in dose relative to baseline) for more than 21 days with the intensification at or after randomisation and before last day on trial product. Results are based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation., Weeks 0-78|Number of TEAEs During Exposure to Trial Product, Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Adverse events (AEs) with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period: Time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-83|Change in Amylase (Ratio to Baseline), Change from baseline (week 0) in amylase (units/litre (U/L)) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52, week 78|Change in Lipase (Ratio to Baseline), Change from baseline (week 0) in lipase (U/L) at weeks 26, 52 and 78 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52, week 78|Change in Pulse Rate, Change from baseline (week 0) in pulse rate was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52, week 78|Change in SBP and DBP, Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at weeks 26, 52 and 78. Results are based on the data from the on-treatment observation period which was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Week 0, week 26, week 52, week 78|Change in ECG Evaluation, Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at weeks 26, 52 and 78. Change from baseline results are presented as shift in findings (normal, abnormal and not clinically significant (NCS) and abnormal and clinically significant (CS)) from week 0 to week 26, 52 and 78. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in Physical Examination, Participants with physical examination findings, normal, abnormal NCS and abnormal CS at baseline (weeks -2), weeks 52 and 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. Results are presented for the following examinations: 1) Cardiovascular system; 2) Central and peripheral nervous system; 3) Gastrointestinal system, incl. mouth; 4) General appearance; 5) Head, ears, eyes, nose, throat, neck; 6) Lymph node palpation; 7) Musculoskeletal system; 8) Respiratory system; 9) Skin; 10) Thyroid gland., Week -2, week 52, week 78|Change in Eye Examination Category, Participants with eye examination (fundoscopy) findings, normal, abnormal NCS and abnormal CS at baseline (week -2), week 52 and week 78 are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week -2, week 52, week 78|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no), This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Weeks 0-83|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no), This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Weeks 0-83|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no), This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide binding antibodies cross reacting with native glucagon-like peptide-1 (GLP-1) anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Weeks 0-83|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no), This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (weeks 0-83) are presented. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Weeks 0-83|Anti-semaglutide Binding Antibody Levels, This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (weeks 0-83). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Weeks 0-83|Number of Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes, Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded during weeks 0-83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia., Weeks 0-83|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes, Treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes were recorded from week 0 to week 83 (78-week treatment period plus the 5-week follow-up period). Hypoglycaemic episodes with onset during the on-treatment observation period were considered treatment-emergent. On-treatment observation period was defined as the time period when a subject was on treatment with trial product, including any period after initiation of rescue medication. Severe hypoglycaemia was defined as an episode requiring assistance of another person to actively administer carbohydrate or glucagon, or take other corrective actions. BG-confirmed symptomatic hypoglycaemia: Confirmed by a glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia., Weeks 0-83|Semaglutide Plasma Concentration in a Subset of the Participants for Population PK Analyses, This outcome measure is only applicable for the oral semaglutide treatment arms (3 mg, 7 mg and 14 mg). Semaglutide plasma concentrations for participants in the pharmacokinetic (PK) subpopulation are presented. The PK subpopulation consisted of participants from sites in Germany, Japan and the United States receiving oral semaglutide (3 mg, 7 mg or 14 mg). Results are based on the data from the on-treatment observation period and follow-up period. The on-treatment observation period was the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-83|Change in SF-36v2 (Acute Version) Health Survey: Scores From the 8 Domains, the Physical Component Summary (PCS) and the Mental Component Summary (MCS), SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The 0-100 scale scores (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. In the metric of norm-based scores, 50 and 10 corresponds to the mean and standard deviation respectively of the 2009 U.S. general population. Change from baseline (week 0) in the domain scores and component summary (PCS and MCS) scores were evaluated at weeks 26, 52 and 78. A positive change score indicates an improvement since baseline. Results are based on the data from the in-trial observation period., Week 0, week 26, week 52, week 78|Change in IWQoL-Lite-CT: Total Score and Scores From the 4 Domains, The Impact of Weight on Quality of Life Clinical Trials Version (IWQOL-Lite-CT) is designed to assess the impact of changes in weight on patients' quality of life within the context of clinical trials. The items of the IWQOL-Lite-CT pertain to physical functioning (physical, physical function and pain/discomfort) and psychosocial domains and all items employ a 5-point graded response scale (never, rarely, sometimes, usually, always; or not at all true, a little true, moderately true, mostly true, completely true). All IWQOL-Lite-CT composite scores range from 0 to 100, with higher scores reflecting better levels of functioning. Results are based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product., Week 0, week 26, week 52, week 78|Change in CoEQ: Scores From the 4 Domains and the 19 Items, Change from baseline (week 0) in Control of Eating Questionnaire (CoEQ) was evaluated at weeks (wk) 26, 52 and 78. The CoEQ comprised 19 items to assess the intensity and type of food cravings, as well as subjective sensation of appetite and mood, with the 4 domains: 'craving control' (items 9-12, 19), 'positive mood' (items 5-8), 'craving for savoury' (items 4, 16-18) and 'craving for sweet' (items 3, 13-15). The 19 items were scored on an 11-point graded response scale ranging from 10 to 0, with items relating to each of the 4 domains being averaged to create a final score. A low score in the domains 'craving for sweet and 'craving for savoury' represents a low level of craving; whereas a high score in the domains 'craving control' and 'positive mood' represents good control and a good mood, respectively. Results are based on the data from the in-trial observation period., Week 0, week 26, week 52, week 78
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 1864
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-02-15
Completion Date: 2018-03-28
Results First Posted: 2020-02-27
Last Update Posted: 2022-07-20
Locations: Novo Nordisk Investigational Site, Anniston, Alabama, 36207, United States|Novo Nordisk Investigational Site, Birmingham, Alabama, 35211, United States|Novo Nordisk Investigational Site, Tuscumbia, Alabama, 35674, United States|Novo Nordisk Investigational Site, Glendale, Arizona, 85308, United States|Novo Nordisk Investigational Site, Little Rock, Arkansas, 72212, United States|Novo Nordisk Investigational Site, Carmichael, California, 95608, United States|Novo Nordisk Investigational Site, Coronado, California, 92118, United States|Novo Nordisk Investigational Site, Encino, California, 91436, United States|Novo Nordisk Investigational Site, Fresno, California, 93720, United States|Novo Nordisk Investigational Site, Los Alamitos, California, 90720, United States|Novo Nordisk Investigational Site, Palm Springs, California, 92262, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Denver, Colorado, 80220, United States|Novo Nordisk Investigational Site, Kissimmee, Florida, 34741, United States|Novo Nordisk Investigational Site, New Port Richey, Florida, 34652, United States|Novo Nordisk Investigational Site, Palm Harbor, Florida, 34684, United States|Novo Nordisk Investigational Site, Plantation, Florida, 33324, United States|Novo Nordisk Investigational Site, Port Charlotte, Florida, 33952, United States|Novo Nordisk Investigational Site, Spring Hill, Florida, 34609, United States|Novo Nordisk Investigational Site, Tampa, Florida, 33607, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30060, United States|Novo Nordisk Investigational Site, Perry, Georgia, 31069, United States|Novo Nordisk Investigational Site, Honolulu, Hawaii, 96814, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83646, United States|Novo Nordisk Investigational Site, Gurnee, Illinois, 60031, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61602, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61603, United States|Novo Nordisk Investigational Site, Avon, Indiana, 46123, United States|Novo Nordisk Investigational Site, Park City, Kansas, 67219, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Louisville, Kentucky, 40213, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42001, United States|Novo Nordisk Investigational Site, Paducah, Kentucky, 42003, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Natchitoches, Louisiana, 71457-5881, United States|Novo Nordisk Investigational Site, Shreveport, Louisiana, 71105, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Waltham, Massachusetts, 02453, United States|Novo Nordisk Investigational Site, Flint, Michigan, 48532, United States|Novo Nordisk Investigational Site, Sterling Heights, Michigan, 48310-3503, United States|Novo Nordisk Investigational Site, Jefferson City, Missouri, 65109, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701-1652, United States|Novo Nordisk Investigational Site, Teaneck, New Jersey, 07666, United States|Novo Nordisk Investigational Site, Trenton, New Jersey, 08611, United States|Novo Nordisk Investigational Site, Albuquerque, New Mexico, 87102, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, Rochester, New York, 14607, United States|Novo Nordisk Investigational Site, West Seneca, New York, 14224, United States|Novo Nordisk Investigational Site, Charlotte, North Carolina, 28277, United States|Novo Nordisk Investigational Site, High Point, North Carolina, 27265, United States|Novo Nordisk Investigational Site, Statesville, North Carolina, 28625, United States|Novo Nordisk Investigational Site, Whiteville, North Carolina, 28472, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Fargo, North Dakota, 58104, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45219, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45236, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43203, United States|Novo Nordisk Investigational Site, Columbus, Ohio, 43213, United States|Novo Nordisk Investigational Site, Franklin, Ohio, 45005, United States|Novo Nordisk Investigational Site, Maumee, Ohio, 43537, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43623, United States|Novo Nordisk Investigational Site, Norman, Oklahoma, 73069, United States|Novo Nordisk Investigational Site, Corvallis, Oregon, 97330-3737, United States|Novo Nordisk Investigational Site, Jersey Shore, Pennsylvania, 17740, United States|Novo Nordisk Investigational Site, McMurray, Pennsylvania, 15317, United States|Novo Nordisk Investigational Site, Gaffney, South Carolina, 29341, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Pelzer, South Carolina, 29669, United States|Novo Nordisk Investigational Site, Summerville, South Carolina, 29485, United States|Novo Nordisk Investigational Site, Bristol, Tennessee, 37620-7352, United States|Novo Nordisk Investigational Site, Humboldt, Tennessee, 38343, United States|Novo Nordisk Investigational Site, Jackson, Tennessee, 38305, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75226, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75246, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Houston, Texas, 77074, United States|Novo Nordisk Investigational Site, Houston, Texas, 77081, United States|Novo Nordisk Investigational Site, Longview, Texas, 75605, United States|Novo Nordisk Investigational Site, Plano, Texas, 75093, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78209, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78224, United States|Novo Nordisk Investigational Site, Sugar Land, Texas, 77478, United States|Novo Nordisk Investigational Site, Waco, Texas, 76710, United States|Novo Nordisk Investigational Site, Murray, Utah, 84123, United States|Novo Nordisk Investigational Site, South Burlington, Vermont, 05403, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Renton, Washington, 98057, United States|Novo Nordisk Investigational Site, Spokane, Washington, 99218, United States|Novo Nordisk Investigational Site, Milwaukee, Wisconsin, 53202, United States|Novo Nordisk Investigational Site, Caba, 1425, Argentina|Novo Nordisk Investigational Site, Caba, C1060ABA, Argentina|Novo Nordisk Investigational Site, Caba, C1179AAB, Argentina|Novo Nordisk Investigational Site, Capital Federal, C1056ABJ, Argentina|Novo Nordisk Investigational Site, Cordoba, 5000, Argentina|Novo Nordisk Investigational Site, Córdoba, 5008, Argentina|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01228-200, Brazil|Novo Nordisk Investigational Site, Angers, 49000, France|Novo Nordisk Investigational Site, Chalons-en-Champagne Cedex, 51005, France|Novo Nordisk Investigational Site, DIJON cedex, 21079, France|Novo Nordisk Investigational Site, LA ROCHE-sur-YON cedex 9, 85295, France|Novo Nordisk Investigational Site, LA ROCHELLE cedex, 17019, France|Novo Nordisk Investigational Site, Le Creusot, 71200, France|Novo Nordisk Investigational Site, Limoges, 87000, France|Novo Nordisk Investigational Site, Marseille, 13006, France|Novo Nordisk Investigational Site, Nanterre, 92014, France|Novo Nordisk Investigational Site, Nantes Cedex 01, 448093, France|Novo Nordisk Investigational Site, Nantes, 44200, France|Novo Nordisk Investigational Site, Narbonne, 11108, France|Novo Nordisk Investigational Site, Paris, 75877, France|Novo Nordisk Investigational Site, PERPIGNAN cedex, 66046, France|Novo Nordisk Investigational Site, Périgueux, 24019, France|Novo Nordisk Investigational Site, Venissieux, 69200, France|Novo Nordisk Investigational Site, Bad Mergentheim, 97980, Germany|Novo Nordisk Investigational Site, Berlin, 12163, Germany|Novo Nordisk Investigational Site, Dresden, 01307, Germany|Novo Nordisk Investigational Site, Elsterwerda, 04910, Germany|Novo Nordisk Investigational Site, Essen, 45219, Germany|Novo Nordisk Investigational Site, Falkensee, 14612, Germany|Novo Nordisk Investigational Site, Friedrichsthal, 66299, Germany|Novo Nordisk Investigational Site, Hamburg, 22607, Germany|Novo Nordisk Investigational Site, Leipzig, 04103, Germany|Novo Nordisk Investigational Site, Münster, 48145, Germany|Novo Nordisk Investigational Site, Saint Ingbert-Oberwürzbach, 66386, Germany|Novo Nordisk Investigational Site, Stuttgart, 70378, Germany|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500034, India|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500072, India|Novo Nordisk Investigational Site, Gurgaon, Haryana, 122001, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560 017, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 4000016, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Pune, Maharashtra, 411040, India|Novo Nordisk Investigational Site, New Dehli, New Delhi, 110029, India|Novo Nordisk Investigational Site, Bhubaneshwar, Orissa, 751003, India|Novo Nordisk Investigational Site, Chandigarh, Punjab, 160012, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302004, India|Novo Nordisk Investigational Site, Jaipur, Rajasthan, 302006, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600 013, India|Novo Nordisk Investigational Site, Chennai, Tamil Nadu, 600086, India|Novo Nordisk Investigational Site, Vellore, Tamil Nadu, 632004, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700014, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700020, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700064, India|Novo Nordisk Investigational Site, Haifa, 31096, Israel|Novo Nordisk Investigational Site, Holon, 58100, Israel|Novo Nordisk Investigational Site, Jerusalem, 91120, Israel|Novo Nordisk Investigational Site, Kfar Saba, 44281, Israel|Novo Nordisk Investigational Site, Petah-Tikva, 49100, Israel|Novo Nordisk Investigational Site, Ra'anana, 43452, Israel|Novo Nordisk Investigational Site, Tel Aviv, 6937947, Israel|Novo Nordisk Investigational Site, Tel-Aviv, 64239, Israel|Novo Nordisk Investigational Site, Asahikawa-shi, Hokkaido, 070-0002, Japan|Novo Nordisk Investigational Site, Gunma, 373-0036, Japan|Novo Nordisk Investigational Site, Hokkaido, 060-0062, Japan|Novo Nordisk Investigational Site, Ibaraki, 311-0113, Japan|Novo Nordisk Investigational Site, Iruma-shi, Saitama, 358-0011, Japan|Novo Nordisk Investigational Site, Kanagawa, 235-0045, Japan|Novo Nordisk Investigational Site, Kashiwara-shi, Osaka, 582-0005, Japan|Novo Nordisk Investigational Site, Kyoto-shi, Kyoto, 601-1495, Japan|Novo Nordisk Investigational Site, Kyoto-shi, Kyoto, 615-0035, Japan|Novo Nordisk Investigational Site, Miyazaki, 880-0034, Japan|Novo Nordisk Investigational Site, Osaka, 569-1045, Japan|Novo Nordisk Investigational Site, Shinjuku-ku, Tokyo, 162-8655, Japan|Novo Nordisk Investigational Site, Shizuoka-shi, Shizuoka, 424-0853, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0027, Japan|Novo Nordisk Investigational Site, Tokyo, 103-0028, Japan|Novo Nordisk Investigational Site, Tokyo, 113-8431, Japan|Novo Nordisk Investigational Site, Toluca, Estado De México, 50130, Mexico|Novo Nordisk Investigational Site, Guadalajara, Jalisco, 44670, Mexico|Novo Nordisk Investigational Site, Ciudad Madero, Tamaulipas, 89440, Mexico|Novo Nordisk Investigational Site, Aguascalientes, 20230, Mexico|Novo Nordisk Investigational Site, San Luis Potosi, 78200, Mexico|Novo Nordisk Investigational Site, Pitesti, Arges, 110084, Romania|Novo Nordisk Investigational Site, Oradea, Bihor, 410025, Romania|Novo Nordisk Investigational Site, Craiova, Dolj, 200642, Romania|Novo Nordisk Investigational Site, Baia Mare, Maramures, 430222, Romania|Novo Nordisk Investigational Site, Targu Mures, Mures, 540098, Romania|Novo Nordisk Investigational Site, Ploiesti, Prahova, 100342, Romania|Novo Nordisk Investigational Site, Timisoara, Timis, 300125, Romania|Novo Nordisk Investigational Site, Bucharest, 020359, Romania|Novo Nordisk Investigational Site, Bucharest, 020475, Romania|Novo Nordisk Investigational Site, Iasi, 700111, Romania|Novo Nordisk Investigational Site, Iasi, 700469, Romania|Novo Nordisk Investigational Site, Satu Mare, 440055, Romania|Novo Nordisk Investigational Site, Timisoara, 300736, Romania|Novo Nordisk Investigational Site, Barnaul, 656045, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117036, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117292, Russian Federation|Novo Nordisk Investigational Site, Moscow, 119435, Russian Federation|Novo Nordisk Investigational Site, Novosibirsk, 630047, Russian Federation|Novo Nordisk Investigational Site, Penza, 440026, Russian Federation|Novo Nordisk Investigational Site, Tomsk, 634041, Russian Federation|Novo Nordisk Investigational Site, Tomsk, 634050, Russian Federation|Novo Nordisk Investigational Site, Yaroslavl, 150062, Russian Federation|Novo Nordisk Investigational Site, Port Elizabeth, Eastern Cape, 6045, South Africa|Novo Nordisk Investigational Site, Bloemfontein, Free State, 9301, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1818, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 1829, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2001, South Africa|Novo Nordisk Investigational Site, Johannesburg, Gauteng, 2198, South Africa|Novo Nordisk Investigational Site, Krugersdorp, Gauteng, 1739, South Africa|Novo Nordisk Investigational Site, Pretoria, Gauteng, 0122, South Africa|Novo Nordisk Investigational Site, Durban, KwaZulu-Natal, 4120, South Africa|Novo Nordisk Investigational Site, Cape Town, Western Cape, 7130, South Africa|Novo Nordisk Investigational Site, Cape Town, 7530, South Africa|Novo Nordisk Investigational Site, Pretoria, 0101, South Africa|Novo Nordisk Investigational Site, Ankara, 06100, Turkey|Novo Nordisk Investigational Site, Istanbul, 34147, Turkey|Novo Nordisk Investigational Site, Istanbul, 34371, Turkey|Novo Nordisk Investigational Site, Istanbul, 34718, Turkey|Novo Nordisk Investigational Site, Istanbul, 34722, Turkey|Novo Nordisk Investigational Site, İstanbul, 34752, Turkey|Novo Nordisk Investigational Site, Istanbul, 34890, Turkey|Novo Nordisk Investigational Site, Istanbul, Turkey|Novo Nordisk Investigational Site, Izmir, 35340, Turkey|Novo Nordisk Investigational Site, Samsun, 55139, Turkey|Novo Nordisk Investigational Site, Cherkasy, 18009, Ukraine|Novo Nordisk Investigational Site, Ivano-Frankivsk, 76018, Ukraine|Novo Nordisk Investigational Site, Kyiv, 04114, Ukraine|Novo Nordisk Investigational Site, Mykolaiv, 54003, Ukraine|Novo Nordisk Investigational Site, Odesa, 65025, Ukraine|Novo Nordisk Investigational Site, Ternopil, 46002, Ukraine|Novo Nordisk Investigational Site, Zaporizhia, 69600, Ukraine|Novo Nordisk Investigational Site, Zhytomyr, 10002, Ukraine|Novo Nordisk Investigational Site, Basingstoke, RG24 9GT, United Kingdom|Novo Nordisk Investigational Site, Cardiff, CF5 4AD, United Kingdom|Novo Nordisk Investigational Site, Chester, CH2 1UL, United Kingdom|Novo Nordisk Investigational Site, Crewe, CW5 5NX, United Kingdom|Novo Nordisk Investigational Site, Doncaster, DN9 2HY, United Kingdom|Novo Nordisk Investigational Site, Leicester, LE5 4PW, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL6 8DH, United Kingdom|Novo Nordisk Investigational Site, Preston, PR2 9HT, United Kingdom|Novo Nordisk Investigational Site, Rotherham, S651DA, United Kingdom|Novo Nordisk Investigational Site, Sidcup, DA14 6LT, United Kingdom|Novo Nordisk Investigational Site, Soham, CB7 5JD, United Kingdom|Novo Nordisk Investigational Site, Swansea, SA2 8PP, United Kingdom|Novo Nordisk Investigational Site, Taunton, TA1 5DA, United Kingdom|Novo Nordisk Investigational Site, Torquay, TQ2 7AA, United Kingdom|Novo Nordisk Investigational Site, Wellingborough, NN8 4RW, United Kingdom
URL: https://clinicaltrials.gov/show/NCT02607865