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Clinical Trial Details

Trial ID: L6425
Source ID: NCT02863328
Associated Drug: Semaglutide
Title: Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus
Acronym: PIONEER 2
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02863328/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: semaglutide|DRUG: empagliflozin
Outcome Measures: Primary: Change in HbA1c, Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on 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 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., Week 0, week 26 | Secondary: Change in Body Weight (Kg), Change from baseline (week 0) in body weight was evaluated at week 26. The endpoint was evaluated based on 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 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., Week 0, week 26|Change in HbA1c (%), Change from baseline (week 0) in HbA1c was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 52|Change in Body Weight (kg), Change from baseline (week 0) in body weight was evaluated at week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 52|Change in Fasting Plasma Glucose, Change from baseline (week 0) in fasting plasma glucose was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26, week 52|Change in SMPG : Mean of the 7-point Profile, Change from baseline (week 0) in mean of the 7-point self-measured plasma glucose (SMPG) (i.e. before and after breakfast, lunch and dinner, and at bedtime) profile was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in SMPG : Mean Postprandial Increment Over All Meals, Change from baseline (week 0) in mean postprandial glucose increment was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting C-peptide (Ratio to Baseline), Change from baseline (week 0) in fasting C-peptide (Nanomoles per liter \[nmol/L\]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting Insulin (Ratio to Baseline), Change from baseline (week 0) in fasting insulin (picomoles per liter \[pmol/L\]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting Pro-insulin (Ratio to Baseline), Change from baseline (week 0) in fasting pro-insulin (pmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting Glucagon (Ratio to Baseline), Change from baseline (week 0) in fasting glucagon (picograms per milliliter \[pg/mL\]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in HOMA-IR (Ratio to Baseline), Change from baseline (week 0) in homeostatic model assessment index of insulin resistance (HOMA-IR) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in HOMA-B (Ratio to Baseline), Change from baseline (week 0) in homeostatic model assessment index of beta-cell function (HOMA-B) (%) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in C-reactive Protein (Ratio to Baseline), Change from baseline (week 0) in C-reactive protein (milligrams per liter \[mg/L\]) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Body Weight (%), Relative change from baseline (week 0) in body weight (kg) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26, week 52|Change in Body Mass Index, Change from baseline (week 0) in body mass index (BMI) was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26, week 52|Change in Waist Circumference, Change from baseline (week 0) in waist circumference was evaluated at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26, week 52|Change in Fasting Total Cholesterol (Ratio to Baseline), Change from baseline (week 0) in fasting total cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting LDL Cholesterol (Ratio to Baseline), Change from baseline (week 0) in fasting low density lipoprotein (LDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting HDL Cholesterol (Ratio to Baseline), Change from baseline (week 0) in fasting high density lipoprotein (HDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting VLDL Cholesterol (Ratio to Baseline), Change from baseline (week 0) in fasting very low density lipoprotein (VLDL) cholesterol (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting Free Fatty Acids (Ratio to Baseline), Change from baseline (week 0) in fasting free fatty acids (FFA) (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. Because of an issue with the handling of the blood samples for FFA, all FFA data are considered invalid for this trial; thus, no conclusion with regards to FFA levels can be made based on the FFA data. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Change in Fasting Triglycerides (Ratio to Baseline), Change from baseline (week 0) in fasting triglycerides (mmol/L) at week 26 and week 52 is presented as ratio to baseline. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26 and week 52|Participants Who Achieve HbA1c <7.0 % (53 mmol/Mol) ADA Target (Yes/no), Participants who achieved HbA1c \<7.0% (53 mmol/mol) (American Diabetes Association (ADA) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 26 and week 52|Participants Who Achieve HbA1c ≤6.5% (48 mmol/Mol), AACE Target (Yes/no), Participants who achieved HbA1c ≤6.5% (48 mmol/mol) (American Association of Clinical Endocrinologists (AACE) target) at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 26 and week 52|Participants Who Achieve Weight Loss ≥5% (Yes/no), Participants who achieved weight loss of ≥5% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 26 and week 52|Participants Who Achieve Weight Loss ≥10% (Yes/no), Participants who achieved weight loss of ≥10% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 26 and week 52|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 \<7.0% (53 mmol/mol) without severe or blood glucose (BG) confirmed symptomatic hypoglycaemia and without weight gain at week 26 and week 52. Severe or BG-confirmed symptomatic hypoglycaemia: an episode, that is severe according to the ADA classification or BG-confirmed by a plasma glucose value \<3.1 mmol/L with symptoms consistent with hypoglycaemia. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 26 and week 52|Participants Who Achieve HbA1c Reduction ≥1% (10.9 mmol/Mol) and Weight Loss ≥3% (Yes/no), Participants who achieved HbA1c reduction ≥1%-point and weight loss of ≥3% at week 26 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 26 and week 52|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 and week 0 to week 52. Additional anti-diabetic medication: use of new anti-diabetic medication for more than 21 days with the initiation at or after randomisation (week 0) and before (planned) end-of-treatment (week 26/week 52), 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. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Weeks 0-52|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 and week 0 to week 52. Rescue medication: use of new antidiabetic medication 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. On-treatment without rescue medication observation period: the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication., Weeks 0-52|Number of Treatment-emergent Adverse Events (TEAE), A treatment-emergent adverse event (TEAE) is defined as an adverse event (AE) with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period)., Weeks 0-57|Change in Amylase (Ratio to Baseline), Change from baseline (week 0) in amylase (units per liter \[U/L\]) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: 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|Change in Lipase (Ratio to Baseline), Change from baseline (week 0) in lipase (U/L) at week 26 and week 52 is presented as ratio to baseline. Results are based on the data from the on-treatment observation period. On-treatment observation period: 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|Change in Pulse Rate, Change from baseline (week 0) in pulse rate was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: 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|Change in Blood Pressure (Systolic and Diastolic Blood Pressure), Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated at week 26 and week 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: 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|Change in ECG, Change from baseline (week 0) in electrocardiogram (ECG) was evaluated at week 26 and week 52. 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 and week 52. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week 0, week 26, week 52|Change in Physical Examination, The physical examination findings (normal, abnormal NCS and abnormal CS) of the participants at week -2 and week 52 are presented for the following examinations: Cardiovascular system, Nervous system (central and peripheral); Gastrointestinal system, incl. mouth; General appearance; Head (ears, eyes, nose), throat, neck; Lymph node palpation; Musculoskeletal system; Respiratory system; Skin; Thyroid gland. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week -2, week 52|Change in Eye Examination, The eye examination findings (normal, abnormal NCS and abnormal CS) of the participants at baseline (week -2) and week 52 are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Week -2, week 52|Occurrence of Anti-semaglutide Binding Antibodies (Yes/no), This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide binding antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Weeks 0-57|Occurrence of Anti-semaglutide Neutralising Antibodies (Yes/no), This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Weeks 0-57|Occurrence of Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no), This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. 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 (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Weeks 0-57|Occurrence of Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no), This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Number of participants who measured with anti-semaglutide neutralising antibodies cross reacting with native GLP-1 anytime during post-baseline visits (week 0 to week 57) are presented. The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Weeks 0-57|Anti-semaglutide Binding Antibody Levels, This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. It is based on the data from participants who were measured with anti-semaglutide antibodies anytime during post-baseline visits (week 0 to week 57). Results are presented as percentage of bound radioactivity-labelled semaglutide /total added radioactivity-labelled semaglutide (%B/T). The results are based on the data from the in-trial observation period. In trial observation period: the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature discontinuation of trial product., Weeks 0-57|Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes, Treatment-emergent hypoglycaemia is an episode with onset in the on-treatment observation period (the time period where participants are considered treated with trial product) and was assessed up to approximately 57 weeks (52-week treatment period plus the 5-week follow-up period). Severe or BG-confirmed symptomatic hypoglycaemia is an episode that is severe according to the American Diabetes Association classification or blood glucose-confirmed by a plasma glucose value \<3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-57|Participants With Treatment-emergent Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes (Yes/no), Number of participants with treatment-emergent severe or BG-confirmed symptomatic hypoglycaemic episodes was recorded during week 0-57. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-57|Semaglutide Plasma Concentrations for Population PK Analyses, Semaglutide plasma concentrations were measured after 25 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-52|SNAC Plasma Concentrations, This outcome measure is only applicable for the oral semaglutide 14 mg treatment arm. Sodium N-\[8-(2-hydroxybenzoyl) amino\]caprylate (SNAC) plasma concentrations were measured after 25 and 40 minutes post-dose at week 4, 26 and 52. Results are based on the data from the on-treatment observation period. On-treatment observation period: the time period when a participant was on treatment with trial product, including any period after initiation of rescue medication., Weeks 0-52|Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (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 and 52. 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|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 26 and 52. 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
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 822
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2016-08-10
Completion Date: 2018-03-08
Results First Posted: 2019-12-24
Last Update Posted: 2022-07-20
Locations: Novo Nordisk Investigational Site, Tuscumbia, Alabama, 35674, United States|Novo Nordisk Investigational Site, Encino, California, 91436, United States|Novo Nordisk Investigational Site, La Mesa, California, 91942, United States|Novo Nordisk Investigational Site, Northridge, California, 91325, United States|Novo Nordisk Investigational Site, Palm Springs, California, 92262-6972, United States|Novo Nordisk Investigational Site, Poway, California, 92064, United States|Novo Nordisk Investigational Site, Riverside, California, 92506, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Bradenton, Florida, 34201, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32216, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32256, United States|Novo Nordisk Investigational Site, Jacksonville, Florida, 32277, United States|Novo Nordisk Investigational Site, Miami Lakes, Florida, 33014, United States|Novo Nordisk Investigational Site, Miami, Florida, 33143, United States|Novo Nordisk Investigational Site, Orlando, Florida, 32801, United States|Novo Nordisk Investigational Site, Oviedo, Florida, 32765, United States|Novo Nordisk Investigational Site, Atlanta, Georgia, 30328, United States|Novo Nordisk Investigational Site, Perry, Georgia, 31069, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83646, United States|Novo Nordisk Investigational Site, Peoria, Illinois, 61603, United States|Novo Nordisk Investigational Site, Evansville, Indiana, 47713, United States|Novo Nordisk Investigational Site, Indianapolis, Indiana, 46254, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40502, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Baton Rouge, Louisiana, 70808-4124, United States|Novo Nordisk Investigational Site, Rockville, Maryland, 20852, United States|Novo Nordisk Investigational Site, Boston, Massachusetts, 02118, United States|Novo Nordisk Investigational Site, Buckley, Michigan, 49620, United States|Novo Nordisk Investigational Site, Kalamazoo, Michigan, 49009, United States|Novo Nordisk Investigational Site, Butte, Montana, 59701, United States|Novo Nordisk Investigational Site, Albany, New York, 12203, United States|Novo Nordisk Investigational Site, Northport, New York, 11768, United States|Novo Nordisk Investigational Site, Wilmington, North Carolina, 28401, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45245, United States|Novo Nordisk Investigational Site, Mason, Ohio, 45040-6815, United States|Novo Nordisk Investigational Site, Philadelphia, Pennsylvania, 19140, United States|Novo Nordisk Investigational Site, Greer, South Carolina, 29651, United States|Novo Nordisk Investigational Site, Humboldt, Tennessee, 38343, United States|Novo Nordisk Investigational Site, Kingsport, Tennessee, 37660, United States|Novo Nordisk Investigational Site, Arlington, Texas, 76012-4637, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Houston, Texas, 77004, United States|Novo Nordisk Investigational Site, Houston, Texas, 77074, United States|Novo Nordisk Investigational Site, Katy, Texas, 77450, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78209, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78228-3419, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78258, United States|Novo Nordisk Investigational Site, Richmond, Virginia, 23219, United States|Novo Nordisk Investigational Site, Caba, C1417EYG, Argentina|Novo Nordisk Investigational Site, Capital Federal, 1405, Argentina|Novo Nordisk Investigational Site, Córdoba, X5006IKK, Argentina|Novo Nordisk Investigational Site, Córdoba, X5016KEH, Argentina|Novo Nordisk Investigational Site, São Paulo, Sao Paulo, 01228-000, Brazil|Novo Nordisk Investigational Site, Porto Alegre, 90035-170, Brazil|Novo Nordisk Investigational Site, Sao Paulo, 05437-010, Brazil|Novo Nordisk Investigational Site, Karlovac, 47000, Croatia|Novo Nordisk Investigational Site, Krapinske Toplice, 49217, Croatia|Novo Nordisk Investigational Site, Pula, 52100, Croatia|Novo Nordisk Investigational Site, Virovitica, 33000, Croatia|Novo Nordisk Investigational Site, Zagreb, 10 000, Croatia|Novo Nordisk Investigational Site, Zagreb, 10000, Croatia|Novo Nordisk Investigational Site, Athens, 115 25, Greece|Novo Nordisk Investigational Site, Athens, GR-10552, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54636, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54642, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-54643, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57001, Greece|Novo Nordisk Investigational Site, Thessaloniki, GR-57010, Greece|Novo Nordisk Investigational Site, Budapest, 1139, Hungary|Novo Nordisk Investigational Site, Budapest, 1152, Hungary|Novo Nordisk Investigational Site, Cegléd, 2700, Hungary|Novo Nordisk Investigational Site, Nyíregyhaza, 4400, Hungary|Novo Nordisk Investigational Site, Salgótarján, 3100, Hungary|Novo Nordisk Investigational Site, Szekszárd, 7100, Hungary|Novo Nordisk Investigational Site, Bologna, 40138, Italy|Novo Nordisk Investigational Site, Lucca, 55100, Italy|Novo Nordisk Investigational Site, Palermo, 90127, Italy|Novo Nordisk Investigational Site, Roma, 00133, Italy|Novo Nordisk Investigational Site, Roma, 00161, Italy|Novo Nordisk Investigational Site, Siena, 53100, Italy|Novo Nordisk Investigational Site, Bialystok, 15-435, Poland|Novo Nordisk Investigational Site, Lublin, 20-538, Poland|Novo Nordisk Investigational Site, Pulawy, 24-100, Poland|Novo Nordisk Investigational Site, Warszawa, 00-911, Poland|Novo Nordisk Investigational Site, Wroclaw, 50-127, Poland|Novo Nordisk Investigational Site, Zabrze, 41-800, Poland|Novo Nordisk Investigational Site, Kazan, 420012, Russian Federation|Novo Nordisk Investigational Site, Moscow, 117292, Russian Federation|Novo Nordisk Investigational Site, Saint Petersburg, 194291, Russian Federation|Novo Nordisk Investigational Site, Saint-Petersburg, 194356, Russian Federation|Novo Nordisk Investigational Site, Saratov, 410053, Russian Federation|Novo Nordisk Investigational Site, Tumen, 625023, Russian Federation|Novo Nordisk Investigational Site, Kragujevac, 34000, Serbia|Novo Nordisk Investigational Site, Nis, 18000, Serbia|Novo Nordisk Investigational Site, Novi Sad, 21000, Serbia|Novo Nordisk Investigational Site, Almería, 04001, Spain|Novo Nordisk Investigational Site, Centelles (Barcelona), 08540, Spain|Novo Nordisk Investigational Site, Hospitalet de Llobregat, 08907, Spain|Novo Nordisk Investigational Site, La Roca del Vallés, 08430, Spain|Novo Nordisk Investigational Site, Pozuelo de Alarcon, 28223, Spain|Novo Nordisk Investigational Site, Sevilla, 41009, Spain|Novo Nordisk Investigational Site, Sevilla, 41010, Spain|Novo Nordisk Investigational Site, Valencia, 46010, Spain|Novo Nordisk Investigational Site, Vic (Barcelona), 08500, Spain|Novo Nordisk Investigational Site, Bangkoknoi, Bangkok, 10700, Thailand|Novo Nordisk Investigational Site, Bangkok, 10400, Thailand
URL: https://clinicaltrials.gov/show/NCT02863328