Health Condition 1: E11- Type 2 diabetes mellitus Health Condition 2: null- Type 2 Diabetes, Overweight or obesity.
Conditions
Interventions
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
Sponsors
Novo Nordisk AS
Novo Nordisk India Private Ltd
Eligibility
Inclusion 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
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baselineTimepoint: 68 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare effect of semaglutide s.c. 2.4 mg once weekly versus semaglutide placebo I/II, on waist circumferenceTimepoint: 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 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 the effect of semaglutide s.c. 1.0 mg once weekly versus semaglutide placebo I/II on HbA1cTimepoint: 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 | — |
Countries
Argentina, Canada, Germany, Greece, India, Japan, Russian Federation, South Africa, Spain, United Arab Emirates, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed