Research study investigating how well semaglutide works in people with type 2 diabetes suffering from overweight or obesity

• Register: EUCTR
• Last refreshed on: 13 July 2020
• Main ID: EUCTR2017-003414-10-GR
• Date of registration: 23/04/2018
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk A/S
• Public title: Research study investigating how well semaglutide works in people with type 2 diabetes suffering from overweight or obesity
• Scientific title: Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity and type 2 diabetes
• Date of first enrolment: 04/05/2018
• Target sample size: 1200
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-003414-10
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: yes Other trial design description: Double dummy If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: yes Other specify the comparator: Semaglutide 1.34 mg Number of treatment arms in the trial: 3
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Algeria, Argentina, Canada, European Union, Greece, India, Japan, Russian Federation, South Africa, Spain, United Arab Emirates, United Kingdom, United States

Contacts

• Name: Clinical Disclosure (1452)
• Affiliation: Novo Nordisk A/S

• Name: Clinical Disclosure (1452)
• Affiliation: Novo Nordisk A/S

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Intervention(s)

Product Name: Semaglutide B 3.0 mg/mL PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.0-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Semaglutide B 1.0 mg/mL PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.0-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Product Name: Semaglutide B 1.34 mg/mL PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Other descriptive name: SEMAGLUTIDE
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1.34-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

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)

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.

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.

Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to week 68
2. After 68 weeks

Secondary Outcome(s)

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. After 68 weeks
2. From baseline (week 0) to week 68
3. From baseline (week 0) to week 68
4. After 68 weeks
5. – 7. From baseline (week 0) to week 75
8. From baseline (week 0) to week 68

Secondary ID(s)

2017-003414-10-GB

NN9536-4374

Source(s) of Monetary Support

Novo Nordisk A/S

Ethics review

Status: Approved
Approval date: 27/04/2018
Contact: