1. Obesity 2. Diabetes Mellitus, Type 2 MedDRA version: 20.0 Level: PT Classification code 10029883 Term: Obesity System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 20.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age = 18 years at the time of signing informed consent. - Body Mass Index (BMI) = 27 kg/sqm - History of at least one self-reported unsuccessful dietary effort to lose body weight - Diagnosed with T2D (HbA1c 7-10% (53-86 mmol/mol) (both inclusive)) = 180 days prior to the day of screening Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 960 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
Exclusion criteria: - A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 30 mL/min/1.73 sqm (< 60 ml/min/1.73 sqm in subjects treated with SGLT2i ) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of semaglutide subcutaneous (s.c.) 2.4 mg once-weekly versus semaglutide placebo I/II as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity and type 2 diabetes (T2D) on body weight.;Primary end point(s): The primary endpoints addressing the primary objective: 1. Change in body weight (%) 2. Subjects who achieve body weight reduction = 5% from baseline (week 0) (yes/no);Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to week 68 2. After 68 weeks;Secondary Objective: To compare the effect of semaglutide s.c. 2.4 mg once-weekly: 1. versus semaglutide placebo I/II as an adjunct to a reduced-calorie diet and increased physical activity in subjects with overweight or obesity and T2D on: - Cardiovascular risk factors - Clinical Outcome Assessments - Glycaemic control 2. versus semaglutide s.c. 1.0 mg once-weekly as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity and T2D on factors related to body weight. 3. To compare the effect of semaglutide s.c. 1.0 mg once-weekly versus semaglutide placebo I/II as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity and T2D on glycaemic control. 4. To compare the safety and tolerability of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo I/II as an adjunct to reduced-calorie diet and increased physical activity in subjects with overweight or obesity and T2D. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Subjects who achieve (yes/no): - Body weight reduction = 10% from baseline (week 0) - Body weight reduction = 15% from baseline (week 0) 2. Change in: - Waist circumference (cm) - Body weight (%) (semaglutide s.c. 2.4 mg once-weekly versus semaglutide s.c. 1.0 mg once-weekly) - Hemoglobin A1c (HbA1c) (%, mmol /mol) - Systolic blood pressure (mmHg) - Physical functioning score (SF-36) - Physical function domain (5-items) score (IWQoL-Lite for CT) 3. Change in: - Body weight (kg) - BMI (kg/sqm) - HbA1c (%, mmol/mol) (semaglutide s.c. 1.0 mg once-weekly versus semaglutide placebo I/II) - Fasting plasma glucose (FPG) (mg/dL) - Fasting serum insulin (mIU/L) - Diastolic blood pressure (mmHg) - Lipids (mg/dL) - Total cholesterol - High density lipoprotein (HDL) cholesterol - Low density lipoprotein (LDL) cholesterol - Very low density lipoprotein (VLDL) cholesterol - Free fatty acids (FFA) - Triglycerides - High sensitivity C-Reactive Protein (hsCRP) (mg/L) - Plasminogen Activator Inhibitor-1 (PAI-1) Activity (AU/mL) - SF-36 - role-physical score - bodily pain score - general health score - vitality score - social functioning score - role-emotional score - mental health score - physical component summary - mental component summary - IWQoL-Lite for CT - pain/discomfort domain score - psychosocial domain score - total score 4. Subjects who achieve (yes/no): - Responder definition value for SF-36 physical functioning score - Responder definition value for IWQoL-Lite for CT physical function domain (5-items) score - HbA1c < 7.0% (53 mmol/mol) - HbA1c = 6.5% (48 mmol/mol) 5. Number of treatment-emergent adverse events (TEAEs) 6. Number of serious adverse events (SAEs) 7. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemia episodes 8. Change in: - Pulse (bpm) - Amylase (U/L) - Lipase (U/L) - Calcitonin (ng/L);Timepoint(s) of evaluation of this end point: 1. Af | — |
Countries
Algeria, Argentina, Canada, European Union, Germany, Greece, India, Japan, Russian Federation, South Africa, Spain, United Arab Emirates, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed