Health Condition 1: null- Diabetes Type 2 Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Semaglutide 0.5mg/week: Injected Subcutaneously
once weekly
following 4 dosesof 0.25 mgsemaglutide weeklysubjects will receive0.5 mg semaglutide weekly for 26 weeks
Intervention2: Semaglutide 1.0mg/week: Injected Subcutaneously
following 4 dosesof 0.25 mg semaglutide weekly and 4 dosesof 0.5 mg semaglutide subjects will receive 1.0 mg semaglutide weekly for 22 weeks
Control Intervention1: Insulin Glargine: Injected Subcutan
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
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 â?? 10.0% (53 - 86 mmol/mol) both inclusive
Exclusion criteria
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 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 ( 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HBA1C from baselineTimepoint: week 0 and week 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Body weight,Fasting plasma glucose (FPG),Self-measured plasma glucose,Systolic and diastolic blood pressure,Patient reported outcomes,Timepoint: week 0 and week 30;Subjects who after 30 weeks treatment achieveTimepoint: After 30 weeks of Treatment | — |
Countries
Argentina, Croatia, France, Germany, India, Mexico, Netherlands, Romania, Slovakia, Slovenia, South Africa, The former Yugoslav Republic of Macedonia, United Kingdom, United States of America
Contacts
Public ContactMr Avik Kumar Gosh
Novo Nordisk India Private Ltd
Outcome results
None listed