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Clinical Trial Details

Trial ID: L3485
Source ID: NCT03136484
Associated Drug: Semaglutide
Title: Efficacy and Safety of Semaglutide Versus Canagliflozin as add-on to Metformin in Subjects With Type 2 Diabetes
Acronym: SUSTAIN 8
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT03136484/results
Conditions: Diabetes|Diabetes Mellitus, Type 2
Interventions: DRUG: Semaglutide|DRUG: Canagliflozin|DRUG: Placebo (canagliflozin)|DRUG: Placebo (semaglutide)
Outcome Measures: Primary: Change in HbA1c, Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first., Week 0, week 52 | Secondary: Change in Body Weight (kg), Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Total Fat Mass (kg), Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in FPG (Fasting Plasma Glucose), Change from baseline (week 0) to week 52 in FPG was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile, Change from baseline (week 0) to week 52 in SMPG- mean 7-point profile was evaluated. 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 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in SMPG- Mean Postprandial Increment Over All Meals, Change from baseline (week 0) to week 52 in SMPG- mean postprandial increment over all meals was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Fasting Total Cholesterol, Change from baseline (week 0) to week 52 in fasting total cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Fasting LDL-cholesterol, Change from baseline (week 0) to week 52 in fasting low-density lipoprotein (LDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Fasting HDL-cholesterol, Change from baseline (week 0) to week 52 in fasting high-density lipoprotein (HDL) cholesterol (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Fasting Triglycerides, Change from baseline (week 0) to week 52 in fasting triglycerides (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Vital Signs (Systolic Blood Pressure and Diastolic Blood Pressure), Change from baseline (week 0) to week 52 in systolic blood pressure and diastolic blood pressure. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Percentage Change in Body Weight (%), Change from baseline (week 0) to week 52 in body weight was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Body Mass Index (BMI), Change from baseline (week 0) to week 52 in BMI was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Waist Circumference, Change from baseline (week 0) to week 52 in waist circumference was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Percentage Change in Total Fat Mass (%), Change from baseline (week 0) to week 52 in total fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Total Lean Mass (kg), Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Percentage Change in Total Lean Mass (%), Change from baseline (week 0) to week 52 in total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Visceral Fat Mass (kg), Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Percentage Change in Visceral Fat Mass (%), Change from baseline (week 0) to week 52 in visceral fat mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Change in Ratio Between Total Fat Mass and Total Lean Mass, Change from baseline (week 0) to week 52 in ratio between total fat mass and total lean mass was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol), American Diabetes Association (ADA) Target (Yes/no), Percentage of participants who achieved HbA1c \< 7.0% (53 millimoles per mole \[mmol/mol\]), ADA target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 52|Participants Who Achieved HbA1c ≤ 6.5% (48 mmol/Mol), American Association of Clinical Endocrinologists (AACE) Target (Yes/no), Percentage of participants who achieved HbA1c ≤ 6.5% (48 mmol/mol), AACE target (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 52|Participants Who Achieved HbA1c Reduction ≥1% (Yes/no), Percentage of participants who achieved ≥1% reduction of baseline HbA1c (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved Weight Loss ≥3% (Yes/no), Percentage of participants losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved Weight Loss ≥5% (Yes/no), Percentage of participants losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved Weight Loss ≥10% (Yes/no), Percentage of participants losing ≥10% of baseline body weight is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG)-Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/no), 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 milligrams per deciliter \[mg/dL\]) with symptoms consistent with hypoglycaemia. Percentage of participants who achieved HbA1c below 7.0% (53 mmol/mol) without severe or blood glucose confirmed symptomatic hypoglycaemia episodes and no weight gain (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥3% (Yes/no), Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥3% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥5% (Yes/no), Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥5% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Participants Who Achieved HbA1c Reduction ≥1% and Weight Loss ≥10% (Yes/no), Percentage of participants who achieved ≥1% reduction of baseline HbA1c and losing ≥10% of baseline body weight (yes/no) is presented. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first., Week 0, week 52|Total Number of Treatment Emergent Adverse Events (TEAEs), A TEAE is defined as an adverse event with onset in the on-treatment observation period (which started at the date of first dose of trial product and included the period after initiation of rescue medication, if any and excluded the period after premature trial product discontinuation, if any. TEAEs assessed up to approximately 57 weeks is presented., Weeks 0-57|Change in Haematological Parameter- Haemoglobin, Change from baseline (week 0) to week 52 in haemoglobin (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Haematological Parameter- Haematocrit, Change from baseline (week 0) to week 52 in haematocrit (%) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Haematological Parameter- Erythrocytes, Change from baseline (week 0) to week 52 in erythrocytes (10\^12 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Haematological Parameter- Leukocytes, Change from baseline (week 0) to week 52 in leukocytes (10\^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Haematological Parameter- Thrombocytes, Change from baseline (week 0) to week 52 in thrombocytes (10\^9 cells/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Amylase, Change from baseline (week 0) to week 52 in amylase (units per liter \[U/L\]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Lipase, Change from baseline (week 0) to week 52 in lipase (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- ALT, Change from baseline (week 0) to week 52 in alanine aminotransferase (ALT) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- AST, Change from baseline (week 0) to week 52 in aspartate aminotransferase (AST) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- ALP, Change from baseline (week 0) to week 52 in alkaline phosphatase (ALP) (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Total Bilirubin, Change from baseline (week 0) to week 52 in total bilirubin (U/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Creatinine, Change from baseline (week 0) to week 52 in creatinine (micromoles per liter \[umol/L\]) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- eGFR, Estimated glomerular filtration rate (eGFR) (milliliters per minute per 1.73 square meters \[mL/min/1.73m\^2\])is calculated using the equation from the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Change from baseline (week 0) to week 52 in eGFR is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Albumin, Change from baseline (week 0) to week 52 in albumin (g/dL) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Calcium, Change from baseline (week 0) to week 52 in calcium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Potassium, Change from baseline (week 0) to week 52 in potassium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Biochemistry Parameter- Sodium, Change from baseline (week 0) to week 52 in sodium (mmol/L) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Calcitonin, Change from baseline (week 0) to week 52 in calcitonin (nanograms per liter) is presented as ratio to baseline. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Pulse, Change from baseline (week 0) to week 52 in pulse is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in ECG, The electrocardiogram (ECG) was assessed by the investigator at baseline (week 0) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Change in Physical Examination, Physical examination parameters are categorised as general appearance; nervous system (central and peripheral); cardiovascular system; gastrointestinal system; skin; respiratory system; lymph node palpation; thyroid gland; left foot; right foot; left leg and right leg. The number of participants assessed as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS) at baseline (week -2) and week 52 is presented based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week -2, week 52|Eye Examination, Fundus photography or a dilated fundoscopy was performed by the investigator at baseline (week 0) and week 52. The results of the examination were interpreted for each eye (left/right) are categorised as normal, abnormal NCS or abnormal CS. Number of participants in each category at baseline and week 52 were presented. Results are based on the 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Week 0, week 52|Total Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes, Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation 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 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Weeks 0-57|Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes, Number of participants with treatment emergent severe or blood glucose-confirmed symptomatic hypoglycaemic episodes. Hypoglycaemic episodes defined as treatment-emergent if the onset of the episode occurs within the on-treatment observation 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 'on-treatment' observation period which started at the date of first dose of trial product and include the period after initiation of rescue medication, if any and excludes the period after premature trial product discontinuation, if any., Weeks 0-57|Change in Short Form 36 Health Survey (SF-36): Sub-domains, 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™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline (week 0) to week 52 in the sub-domain scores is presented. A positive change score indicate an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 52|Change in SF-36: Physical Component Summary (PCS), Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain PCS. SF-36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. It consists of 2 component summary measures that further summarize 8 health domain scales. The PCS measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 52|Change in SF-36: Mental Component Summary (MCS), Change from baseline (week 0) to week 52 in short form 36 v2.0 acute domain MCS. SF- 36v2™ questionnaire measured the HRQoL on 8 domains on individual scale ranges. The MCS measure is derived from domain scales of vitality, social functioning, role emotional and mental health. The scores 0-100 (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. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 52|Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment Satisfaction Summary Score (Sum of 6 of 8 Items) and the 8 Items Separately, Change from baseline (week 0) in DTSQ was evaluated at week 52. The DTSQs items are scored on a 7-point graded response scale ranging from 6 to 0. Higher scores indicate higher levels of treatment satisfaction for DTSQs items 1, 4 -8. For items 2 and 3 a higher score indicates a higher patient perceived experience of high blood sugars and low blood sugars, respectively. Thus, lower scores indicate a perception of blood glucose levels being "none of the time" unacceptably high (item 2) or low (item 3). The domain score of total treatment satisfaction (total treatment satisfaction score) was computed by adding the six items scores 1, 4-8. The score ranges 0-36. A higher treatment satisfaction score indicates a higher level of treatment satisfaction. Results are based on the 'on-treatment without rescue medication' observation period., Week 0, week 52|Change in Control of Eating Questionnaire (CoEQ): Domains, 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', 'craving for sweet', 'craving for savoury' and 'positive mood'. 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 'on-treatment without rescue medication' observation period., Week 0, week 52|Change in CoEQ: Individual Items, 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', 'craving for sweet', 'craving for savoury' and 'positive mood'. 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 'on-treatment without rescue medication' observation period., Week 0, week 52
Sponsor/Collaborators: Sponsor: Novo Nordisk A/S
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 788
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-03-15
Completion Date: 2018-11-16
Results First Posted: 2019-12-17
Last Update Posted: 2020-01-21
Locations: Novo Nordisk Investigational Site, Anaheim, California, 92801, United States|Novo Nordisk Investigational Site, La Mesa, California, 91942, United States|Novo Nordisk Investigational Site, Los Angeles, California, 90057, United States|Novo Nordisk Investigational Site, Montclair, California, 91763, United States|Novo Nordisk Investigational Site, San Diego, California, 92111, United States|Novo Nordisk Investigational Site, Spring Valley, California, 91978, United States|Novo Nordisk Investigational Site, Tustin, California, 92780, United States|Novo Nordisk Investigational Site, Walnut Creek, California, 94598, United States|Novo Nordisk Investigational Site, Fleming Island, Florida, 32003, United States|Novo Nordisk Investigational Site, Hallandale Beach, Florida, 33009, United States|Novo Nordisk Investigational Site, Hialeah, Florida, 33012, United States|Novo Nordisk Investigational Site, Miami, Florida, 33135, United States|Novo Nordisk Investigational Site, Miami, Florida, 33155, United States|Novo Nordisk Investigational Site, Miami, Florida, 33174, United States|Novo Nordisk Investigational Site, Miami, Florida, 33175, United States|Novo Nordisk Investigational Site, Miami, Florida, 33186, United States|Novo Nordisk Investigational Site, Spring Hill, Florida, 34609, United States|Novo Nordisk Investigational Site, Conyers, Georgia, 30094-5965, United States|Novo Nordisk Investigational Site, Marietta, Georgia, 30060, United States|Novo Nordisk Investigational Site, Meridian, Idaho, 83646, United States|Novo Nordisk Investigational Site, Council Bluffs, Iowa, 51501, United States|Novo Nordisk Investigational Site, Lexington, Kentucky, 40503, United States|Novo Nordisk Investigational Site, Lake Charles, Louisiana, 70601, United States|Novo Nordisk Investigational Site, Metairie, Louisiana, 70002, United States|Novo Nordisk Investigational Site, Baltimore, Maryland, 21239, United States|Novo Nordisk Investigational Site, Hyattsville, Maryland, 20782, United States|Novo Nordisk Investigational Site, Detroit, Michigan, 48202, United States|Novo Nordisk Investigational Site, Flint, Michigan, 48504, 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, Troy, Michigan, 48098, United States|Novo Nordisk Investigational Site, Trenton, New Jersey, 08611, United States|Novo Nordisk Investigational Site, Brooklyn, New York, 11229, United States|Novo Nordisk Investigational Site, New Windsor, New York, 12553, United States|Novo Nordisk Investigational Site, Greensboro, North Carolina, 27408, United States|Novo Nordisk Investigational Site, Cincinnati, Ohio, 45212, United States|Novo Nordisk Investigational Site, Maumee, Ohio, 43537, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43614, United States|Novo Nordisk Investigational Site, Toledo, Ohio, 43623, United States|Novo Nordisk Investigational Site, Corvallis, Oregon, 97330-3737, United States|Novo Nordisk Investigational Site, Anderson, South Carolina, 29621, United States|Novo Nordisk Investigational Site, Amarillo, Texas, 79106, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78404, United States|Novo Nordisk Investigational Site, Corpus Christi, Texas, 78413, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75230, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75251, United States|Novo Nordisk Investigational Site, Dallas, Texas, 75390-9302, United States|Novo Nordisk Investigational Site, Houston, Texas, 77058, United States|Novo Nordisk Investigational Site, Houston, Texas, 77074, United States|Novo Nordisk Investigational Site, Houston, Texas, 77081, United States|Novo Nordisk Investigational Site, Katy, Texas, 77450, United States|Novo Nordisk Investigational Site, San Antonio, Texas, 78230, United States|Novo Nordisk Investigational Site, Splendora, Texas, 77372, United States|Novo Nordisk Investigational Site, Saint George, Utah, 84790, United States|Novo Nordisk Investigational Site, Herndon, Virginia, 20171, United States|Novo Nordisk Investigational Site, Olympia, Washington, 98502, United States|Novo Nordisk Investigational Site, Wenatchee, Washington, 98801-2028, United States|Novo Nordisk Investigational Site, Buenos Aires, C1250AAN, Argentina|Novo Nordisk Investigational Site, Caba, C1093AAS, Argentina|Novo Nordisk Investigational Site, Caba, C1430CKE, Argentina|Novo Nordisk Investigational Site, Rosario, S2000CUD, Argentina|Novo Nordisk Investigational Site, Salta, 4400, Argentina|Novo Nordisk Investigational Site, Porto Alegre, 90035-170, Brazil|Novo Nordisk Investigational Site, Rio de Janeiro, 22271-100, Brazil|Novo Nordisk Investigational Site, Surrey, British Columbia, V3S 2N6, Canada|Novo Nordisk Investigational Site, Brampton, Ontario, L6T 0G1, Canada|Novo Nordisk Investigational Site, Burlington, Ontario, L7M 4Y1, Canada|Novo Nordisk Investigational Site, London, Ontario, N5W 6A2, Canada|Novo Nordisk Investigational Site, Sarnia, Ontario, N7T 4X3, Canada|Novo Nordisk Investigational Site, Toronto, Ontario, M9V 4B4, Canada|Novo Nordisk Investigational Site, Pointe Claire, Quebec, H9R 4S3, Canada|Novo Nordisk Investigational Site, Pointe-Claire, Quebec, H9R 3J1, Canada|Novo Nordisk Investigational Site, Hyderabad, Andhra Pradesh, 500034, India|Novo Nordisk Investigational Site, Rohtak, Haryana, 124001, India|Novo Nordisk Investigational Site, Bangalore, Karnataka, 560054, India|Novo Nordisk Investigational Site, Kochi, Kerala, 682041, India|Novo Nordisk Investigational Site, Mumbai, Maharashtra, 400008, India|Novo Nordisk Investigational Site, Nagpur, Maharashtra, 440008, 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, 600001, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700020, India|Novo Nordisk Investigational Site, Kolkata, West Bengal, 700054, India|Novo Nordisk Investigational Site, Dublin, DUBLIN 15, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 4, Ireland|Novo Nordisk Investigational Site, Dublin, DUBLIN 7, Ireland|Novo Nordisk Investigational Site, Galway, H91 YR71, Ireland|Novo Nordisk Investigational Site, Mallow, P51Y8EC, Ireland|Novo Nordisk Investigational Site, Milano, 20100, Italy|Novo Nordisk Investigational Site, Achrafieh, Lebanon|Novo Nordisk Investigational Site, Hazmieh, Lebanon|Novo Nordisk Investigational Site, Lebanon - Beirut, 9611, Lebanon|Novo Nordisk Investigational Site, Mansourieh, Lebanon|Novo Nordisk Investigational Site, Zgharta, 9616, Lebanon|Novo Nordisk Investigational Site, Alor Gajah, 78300, Malaysia|Novo Nordisk Investigational Site, Ipoh, 30450, Malaysia|Novo Nordisk Investigational Site, Melaka, 75400, Malaysia|Novo Nordisk Investigational Site, Penang, 10450, Malaysia|Novo Nordisk Investigational Site, Sandakan, 90000, Malaysia|Novo Nordisk Investigational Site, Seremban, 70300, Malaysia|Novo Nordisk Investigational Site, Cuernavaca, Morelos, 62250, Mexico|Novo Nordisk Investigational Site, Mexico City, México, D.F., 02230, Mexico|Novo Nordisk Investigational Site, Monterrey, Nuevo León, 64620, Mexico|Novo Nordisk Investigational Site, Eksjö, 575 35, Sweden|Novo Nordisk Investigational Site, Kristianstad, 291 85, Sweden|Novo Nordisk Investigational Site, Lund, 221 85, Sweden|Novo Nordisk Investigational Site, Malmö, 205 02, Sweden|Novo Nordisk Investigational Site, Örebro, 701 85, Sweden|Novo Nordisk Investigational Site, Basingstoke, RG24 9GT, United Kingdom|Novo Nordisk Investigational Site, Bradford-on-Avon, BA15 1DQ, United Kingdom|Novo Nordisk Investigational Site, Dundee, DD1 9SY, United Kingdom|Novo Nordisk Investigational Site, Haxey, DN9 2HY, United Kingdom|Novo Nordisk Investigational Site, Nottingham, NG7 2UH, United Kingdom|Novo Nordisk Investigational Site, Plymouth, PL8 8DQ, United Kingdom|Novo Nordisk Investigational Site, Soham, CB7 5JD, United Kingdom|Novo Nordisk Investigational Site, Southampton, SO30 3JB, United Kingdom|Novo Nordisk Investigational Site, Stevenage, SG1 4AB, 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/NCT03136484