Efficacy and safety of semaglutide once-weekly versus exenatide ER 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.
- Conditions
- diabetesdiabetes mellitus type 210018424
- Registration Number
- NL-OMON40243
- Lead Sponsor
- ovo Nordisk
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
*Male or female, age * 18 years at the time of signing informed consent.
*Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin * 1500 mg or maximum tolerated dose and/or TZD and/or SUs * half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose
*HbA1c 7.0 * 10.5 % (53 * 91 mmol/mol) (both inclusive)
*Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice)
*Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject*s safety or compliance with the protocol
*Treatment with 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 inter-current illness
*History of chronic or idiopathic acute pancreatitis
*Screening calcitonin value * 50 ng/L (pg/mL)
*Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
*Impaired renal function defined as eGFR < 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version)
*Acute coronary or cerebrovascular event within 90 days before randomisation
*Heart failure, New York Heart Association (NYHA) class IV
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline to week 56 in HbA1c.</p><br>
- Secondary Outcome Measures
Name Time Method <p>*Change from baseline to week 56 in body weight<br /><br>*Change from baseline to week 56 in: Fasting Plasma Glucose (FPG), Systolic and<br /><br>diastolic blood pressure, Patient reported outcome (PRO) questionnaire Diabetes<br /><br>Treatment Satisfaction Questionnaire status (DTSQs)<br /><br>*Subjects who after 56 weeks treatment achieve (yes/no): HbA1c *6.5% (48<br /><br>mmol/mol) American Association of Clinical Endocrinologists (AACE) target</p><br>