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

Phase 3

Active, not recruiting

• Conditions: Type 2 diabetes mellitus, Type 2 Diabetes, Overweight or obesity. ,

• Registration Number: CTRI/2018/06/014512
• Lead Sponsor: Novo Nordisk AS

Brief Summary

This is a 68-week, randomised, double-blinded, double dummy, placebo-controlled, multicentre trial.  Subjects will be randomised in a 1:1:1 manner to receive either: - Semaglutide s.c. 2.4 mg and semaglutide placebo II once-weekly - Semaglutide s.c. 1.0 mg and semaglutide placebo I once-weekly - Semaglutide placebo I and semaglutide placebo II once-weekly All as an adjunct to a reduced-calorie diet and increased physical activity. There is a 1 week screening period followed by a randomisation visit and a 68-week treatment period. The treatment period is divided into a dose escalation period of 16 weeks and a maintenance period of 52 weeks. Subsequently there is a follow-up period of 7 weeks. The trial population will consist of subjects with BMI > 27 kg/m2 with T2D on 0-3 OADs but not treated with insulin.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-26
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 1210

Inclusion Criteria

• 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.
• 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.
• 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 the trial, except for minor surgical procedures, in the opinion of the investigator 24.
• Known or suspected abuse of alcohol or recreational drugs 25.
• Known or suspected hypersensitivity to trial product(s) or related products 26.
• Previous participation in this trial.
• Participation is defined as signed informed consent 27.
• Other subject(s) from the same household participating in any semaglutide trial 29.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 30.
• Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator’s opinion, might jeopardise the subject’s safety or compliance with the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in body weight from baseline	68 Weeks

Secondary Outcome Measures

Name	Time	Method
To compare effect of semaglutide s.c. 2.4 mg onceweekly versus semaglutide placebo I/II in achieving weight reduction of ≥ 10% and ≥ 15%.	68 Weeks
To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo I/II, on waist circumference	68 weeks
To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide s.c. 1.0mg once-weekly, on body weight	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 .	68 Weeks
To compare the effect of semaglutide s.c. 1.0 mg once weekly versus semaglutide placebo I/II on HbA1c	68 Weeks

Trial Locations

Locations (19)

Apollo Gleneagles Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

All India Institute of Medical Sciences; 🇮🇳 Delhi, DELHI, India

Amrita Institute of Medical Sciences & Research Centre; 🇮🇳 Ernakulam, KERALA, India

Dr Jivraj Mehta Samark Health Foundation Bakeri Medical Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Eternal Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Fortis Hospital; 🇮🇳 Delhi, DELHI, India

Grant Government Medical College & Sir JJ Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

ILS Hospital; 🇮🇳 Kolkata, WEST BENGAL, India

KEM Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

King George Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

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Apollo Gleneagles Hospital

🇮🇳Kolkata, WEST BENGAL, India

Dr Debasis Basu

Principal investigator

9831256908

drdebasis_b@apollohospitals.onmicrosoft.com

Dr Tirthankar Chaudhury

Principal investigator

9831322394

tchaudhury67@yahoo.co.uk