Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Semaglutide
: 0.5 mg or 1.0 mg once weekly s.c. Injection
Control Intervention1: Dulaglutide
: 0.75 mg or 1.5 mg once weekly s.c. Injection
Sponsors
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. Subjects with T2D diagnosed clinically >= 90 days prior to screening 4. HbA1c 7.0 â?? 10.5% (53 â?? 91 mmol/mol) (both inclusive) 5. Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening"
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to trial product(s) or related products 2. Previous participation in this trial. Participation is defined as signed informed consent 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). 4. Receipt of any investigational medicinal product within 90 days before screening 5. Any condition, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol 6. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of 7. History of pancreatitis (acute or chronic) 8. Screening calcitonin >=50 ng/L 9. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma 10. Renal impairment defined as eGFR 60 mL/min/1.73 m2 as per CKD-EPI 11. Any of the following: myocardial infarction (MI), stroke or hospitalisation for unstable angina and/or transient ischaemic attack (TIA) within the past 180 days prior to the day of screening 12. Subjects presently classified as being in New York Heart Association (NYHA) Class IV 13. Planned coronary, carotid or peripheral artery revascularisation on the day of screening 14. Proliferative retinopathy or maculopathy requiring acute treatment 15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) 16. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c Timepoint: 40 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weightTimepoint: 40 weeks | — |
Countries
Bulgaria, Canada, Croatia, Finland, Germany, Greece, Hong Kong, India, Ireland, Latvia, Lithuania, Portugal, Romania, Slovakia, Spain, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed