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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/06/014512
• Date of registration: 12-06-2018
• Prospective Registration: Yes
• Primary sponsor: Novo Nordisk AS
• Public title: STEP 2 : 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: 26-07-2018
• Target sample size: 1210
• Recruitment status: Closed to Recruitment of Participants
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=23170
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
• Phase: Phase 3

Countries of recruitment

Argentina, Canada, Germany, Greece, India, Japan, Russian Federation, South Africa, Spain, United Arab Emirates, United Kingdom, United States of America

Contacts

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

• Name: Dr Anil N Shinde
• Affiliation: Novo Nordisk India Private Ltd.

Key inclusion & exclusion criteria

Inclusion criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

2. Male or female, age >= 18 years at the time of signing informed consent.

3. Body Mass Index (BMI) >= 27 kg/m2

4. History of at least one self-reported unsuccessful dietary effort to lose body weight

5. Diagnosed with T2D >= 180 days prior to the day of screening

6. Subject treated with either:

i. diet and exercise alone or stable treatment with metformin, SU, SGLT2i, glitazone as single agent therapy or

ii. up to 3 OADs (metformin, SU, SGLT2i or glitazone) according to local label

7. HbA1c 7-10% (53-86 mmol/mol) (both inclusive)
Exclusion criteria: Diabetes Related:1. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior day of screening

2. Receipt of any other anti-diabetic investigational drug within 90 days prior to screening for this trial, or receipt of any investigational drugs not affecting diabetes within 30 days prior to screening for this trial

3. Treatment with a GLP-1 receptor agonist within 180 days prior to screening

4. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 30 mL/min/1.73 m2 ( < 60 mL/min/1.73 m2 in subjects treated with SGLT2i ) according to CKD-EPI creatinine equation as defined by KDIGO 201242 by the central laboratory at screening

5. 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



Obesity related:

6. A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records

7. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed > 1 year before screening, (2) lap banding, if the band has been removed > 1 year before screening, (3) intragastric balloon, if the balloon has been removed > 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed > 1 year before screening

8. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.4 mIU/L as measured by central laboratory at screening



Mental Health:

9. History of major depressive disorder within 2 years before screening

10. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)

11. A Patient Health Questionnaire-9 (PHQ-9) score of >= 15 at screening

12. A lifetime history of a suicidal attempt

13. Suicidal behaviour within 30 days before screening

14. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening



General safety:

15. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening

16. Presence of acute pancreatitis within the past 180 days prior to the day of screening

17. History or presence of chronic pancreatitis

18. Calcitonin >= 100 ng/L as measured by the central laboratory at screening

19. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma

20. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed

21. Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina or transient ischaemic attack within the past 60 days prior to screening

22. Subject presently classified as being in New York Heart Association (NYHA) Class IV

23. Surgery scheduled for the duration of th

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: E11- Type 2 diabetes mellitus Health Condition 2: null- Type 2 Diabetes, Overweight or obesity.

Intervention(s)

Intervention1: Semaglutide: 2.4mg/1.0mg once weekly prefilled pen injector for sub cutaneous injection
Control Intervention1: Placebo: 2.4mg/1.0mg once weekly prefilled pen injector for sub cutaneous injection

Primary Outcome(s)

Change in body weight from baselineTimepoint: 68 Weeks

Secondary Outcome(s)

To compare effect of semaglutide s.c. 2.4 mg onceweekly versus semaglutide placebo I/II in achieving weight reduction of â?¥ 10% and â?¥ 15%.Timepoint: 68 Weeks

To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo I/II, on waist circumferenceTimepoint: 68 weeks

To compare the effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo I/II on body weight, BMI,and fasting plasma glucose .Timepoint: 68 Weeks

To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide s.c. 1.0mg once-weekly, on body weightTimepoint: 68 Weeks

To compare the effect of semaglutide s.c. 1.0 mg once weekly versus semaglutide placebo I/II on HbA1cTimepoint: 68 Weeks

Secondary ID(s)

NN9536-4374, version -2.0, dated 21 Dec 2017

U1111-1200-8148

Source(s) of Monetary Support

Novo Nordisk India Private Ltd. Plot No.32, 47 - 50, EPIP Area, Whitefield Bangalore Karnataka-560 066.

Secondary Sponsor(s)

Novo Nordisk India Private Ltd

Ethics review

Status: Approved
Approval date: 06/05/2018
Contact:

Institutional Ethics Committee Fortis Hospital

Status: Approved
Approval date: 29/05/2018
Contact:

DR. JIVRAJ MEHTA SMARAK HEALTH FOUNDATION

Status: Approved
Approval date: 30/05/2018
Contact:

Institutional Ethics Committee Kovai Diabetes Specialty Center

Status: Approved
Approval date: 31/05/2018
Contact:

KIMS Ethics Committee

Status: Approved
Approval date: 02/06/2018
Contact:

Institutional Ethics Committee Noble Hospital

Status: Approved
Approval date: 08/06/2018
Contact:

Eternal Heart Care Centre and Research Institute

Status: Approved
Approval date: 09/06/2018
Contact:

Institutional Ethics Committee Apollo Gleneagles

Status: Approved
Approval date: 26/06/2018
Contact:

Ethics committee M S Ramaiah

Status: Approved
Approval date: 27/06/2018
Contact:

Ethics committee ils hospital

Status: Approved
Approval date: 27/06/2018
Contact:

Institutional Ethics Committee Grant Govt medical college

Status: Approved
Approval date: 28/06/2018
Contact:

Institutional Ethics Committee AIIMs

Status: Approved
Approval date: 11/07/2018
Contact:

Institute Ethics Committee Madras Diabetes Research Foundation

Status: Approved
Approval date: 14/07/2018
Contact:

Institutional Ethics Committee, Zydus Hospital

Status: Approved
Approval date: 26/07/2018
Contact:

Ethics Committee, Prof. M Vishwanthan Diabetes Research Centre

Status: Approved
Approval date: 06/08/2018
Contact:

Institutional Ethics Committee BYL Nair Hospital

Status: Approved
Approval date: 07/08/2018
Contact:

Institutional Ethics Committee Amrita institute

Status: Approved
Approval date: 22/09/2018
Contact:

Institutional Ethics Committee KEM Hospital