A trial to evaluate the Efficacy and safety of semaglutide given once weekly versus insulin glargine given once daily as add on to metformin with or without sulphonylurea in subjects with type 2 diabetes ,who have not yet been treated with insulin.

Phase 3

Completed

• Conditions: Type 2 diabetes mellitus,

• Registration Number: CTRI/2014/09/005033
• Lead Sponsor: Novo Nordisk AS

Brief Summary

**A study to evaluate Efficacy and safety of semaglutide once weekly versus insulin glargine once daily as add on to metformin with or without sulphonylurea in insulin-naïve subjects with type 2 diabetes.Globally 14 countries are participating.**

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-22
• Study Completion: 2015-08-27
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 1047

Inclusion Criteria

• Male or female, age ≥18 years at the time of signing informed consent -Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin ≥1500 mg or maximum tolerated dose and SU ≥ half of maximum allowed dose according to national label) for at least 90 days before screening.Stable is defined as unchanged medication and unchanged dose -HbA1c 7.0 – 10.0% (53.
• 86 mmol/mol) both inclusive.

Exclusion Criteria

• Female who is pregnant, breast-feeding or intends to become pregnant or of childbearing potential not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice) throughout the trial including the 5 week follow-up period.
• Any disorder which, in the opinion of the investigator might jeopardise subject’s safety or compliance with the protocol -Treatment with any glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening.
• An exception is short-term treatment (≤7 days in total) with insulin in connection with intercurrent illness -History of chronic or idiopathic acute pancreatitis -Screening calcitonin value ≥50 ng/L -Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome 2 (MEN2) -Acute coronary or cerebrovascular event within 90 days before randomisation -Heart failure, New York Heart Association Class IV -Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator.
• Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer) -Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HBA1C from baseline	week 0 and week 30

Secondary Outcome Measures

Name	Time	Method
Change in	Body weight,Fasting plasma glucose (FPG),Self-measured plasma glucose,Systolic and diastolic blood pressure,Patient reported outcomes,
Subjects who after 30 weeks treatment achieve	After 30 weeks of Treatment

Trial Locations

Locations (15)

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

B.Y.L. Nair Hospital and T.N.Medical College,; 🇮🇳 Mumbai, MAHARASHTRA, India

Cauvery Medical Centre Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Columbia Asia  Hospital - Hebbal,; 🇮🇳 Bangalore, KARNATAKA, India

Dr. Jivraj Mehta Health Foundation; 🇮🇳 Ahmadabad, GUJARAT, India

Fortis Hospital,; 🇮🇳 Kolkata, WEST BENGAL, India

Global Hospitals Superspeciality and Transplant center,; 🇮🇳 Mumbai, MAHARASHTRA, India

HCG Multi Speciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

JSS Hospital,; 🇮🇳 Mysore, KARNATAKA, India

Krishna Rajendra Hospital (K R Hospital),; 🇮🇳 Mysore, KARNATAKA, India

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All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr M Ashraf Ganie

Principal investigator

01126593237

ashraf.endo@gmail.com