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
- Diabetes Mellitus, Type 2MedDRA version: 16.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2012-004826-92-NL
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 798
1. Male or female, age = 18 years at the time of signing informed consent
2. 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 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
3. HbA1c 7.0 – 10.5 % (53 – 91 mmol/mol) (both inclusive)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 639
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 159
1. 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)
2. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject’s safety or compliance with the protocol
3. 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
4. History of chronic or idiopathic acute pancreatitis
5. Screening calcitonin value = 50 ng/L (pg/mL)
6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2)
7. Impaired renal function defined as eGFR < 60 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 (NYHA) class IV
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the effect of semaglutide 1.0 mg once-weekly versus exenatide extended release (ER) 2.0 mg once-weekly on glycaemic control after 56 weeks of treatment;Secondary Objective: To compare the effect of semaglutide 1.0 mg once-weekly versus exenatide ER 2.0 mg once-weekly after 56 weeks of treatment on:<br>- Inducing and maintaining weight loss<br>- Other parameters of efficacy, safety and tolerability;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline to week 56
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Confirmatory efficacy endpoint:<br>1. Change in body weight<br>Supportive efficacy endpoints:<br>Change in:<br>2. Fasting Plasma Glucose (FPG)<br>3. Systolic and diastolic blood pressure<br>4. Patient reported outcome (PRO) questionnaire Diabetes Treatment Satisfaction Questionnaire status (DTSQs)<br>These endpoints will be evaluated as the mean treatment differences.<br><br>5. Subjects who achieve HbA1c =6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no)<br>This endpoint will be evaluated as the odds ratio between treatments.;Timepoint(s) of evaluation of this end point: 1. - 4. From baseline to week 56<br>5. After 56 weeks' treatment