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
- Conditions
- diabetesdiabetes mellitus type 210018424
- Registration Number
- NL-OMON41148
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
1. Male or female, age *18 years at the time of signing informed consent;2. 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;3. HbA1c 7.0 * 10.0% (53 - 86 mmol/mol) both inclusive
1. 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;2. Any disorder which, in the opinion of the Investigator might jeopardise subject*s safety or compliance with the protocol;3. 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;4. History of chronic or idiopathic acute pancreatitis;5. Screening calcitonin value *50 ng/L;6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2;7. Severe renal impairment defined as eGFR <30 mL/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable version);8. Acute coronary or cerebrovascular event within 90 days before randomisation;9. Heart failure, New York Heart Association Class IV;10. Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator;11. Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline to week 30 in HbA1c. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Change from baseline to week 30 in:<br /><br>* body weight<br /><br>* Fasting plasma glucose (FPG)<br /><br>* Systolic and diastolic blood pressure<br /><br>* Patient reported outcome questionnaires (PROs)<br /><br><br /><br>Subjects who after 30 weeks treatment achieve (yes/no):<br /><br>* HbA1c *6.5% (48 mmol/mol) American Association of Clinical Endocrinologists<br /><br>(AACE) target</p><br>