Dose-finding of semaglutide administered subcutaneously once daily versus placebo and liraglutide in subjects with type 2 diabetes
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 19.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2014-003196-39-GB
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 705
1. Male or female, age =18 years at the time of signing informed consent
2. Subjects should be on stable diabetes treatment consisting of diet and exercise with or without metformin (=1500 mg daily or maximum tolerated dose documented in the patient medical record) for at least 90 days prior to screening
3. HbA1c: 53-86 mmol/mol (7.0-10.0%) (both inclusive)
4. BMI: 25.0 – 40.0 kg/m^2 (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 564
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
1. Simultaneous participation in any other clinical trial of an investigational medicinal product
2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods throughout the trial including the 7 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). Germany: Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner. United Kingdom: Adequate contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository), female sterilisation, male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle).
3. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening (an exception is short-term insulin treatment for acute illnesses for a total of =14 days)
4. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on an frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
5. History of pancreatitis (acute or chronic)
6. Screening calcitonin =50 ng/L
7. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
8. Severe to moderate renal impairment defined as GFR, estimated <60 ml/min/1.73 m^2 as per CKD-EPI
9. Within the past 180 days before screening any of the following: Myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
10. Currently planned coronary, carotid or peripheral artery revascularisation
11. Patients presently classified as being in New York Heart Association (NYHA) Class III or 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 efficacy of four (4) dose-levels of semaglutide administered subcutanously (s.c.) once daily (OD) versus placebo on glycaemic control after 26 weeks of treatment;<br> Secondary Objective: 1. To compare the efficacy of semaglutide administered s.c. OD versus liraglutide on glycaemic control after 26 weeks of treatment.<br> 2. To compare semaglutide administered s.c. OD versus placebo and liraglutide on other parameters of efficacy, patient reported outcomes, safety and tolerability after 26 weeks of treatment.<br> ;Primary end point(s): Change in HbA1c ;Timepoint(s) of evaluation of this end point: From baseline to week 26
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Change in:<br> 1. Fasting plasma glucose (FPG)<br> 2. Body weight<br> 3. Systolic and diastolic blood pressure<br> ;Timepoint(s) of evaluation of this end point: From baseline to week 26