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.
- Conditions
- Health Condition 1: null- Diabetes Type 2Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2014/09/005033
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 83
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 â?? 10.0% (53 - 86 mmol/mol) both inclusive
-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 subjectâ??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
- Secondary Outcome Measures
Name Time Method