Efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve 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
- EUCTR2013-000632-94-GB
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 390
1. Male or female, age equal to or above 18 years at the time of signing informed consent
2. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
3. Subjects diagnosed with type 2 diabetes and treated with diet and exercise for at least 30 days before screening
4. HbA1c 7.0 – 10.0 % (53 - 86 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 312
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 78
1. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and 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. 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), male sterilisation (where partner is sole partner of subject), or true abstinence (when in line with preferred and usual lifestyle)
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 any glucose lowering agent(s) in a period of 90 days prior to screening. An exception is short-term treatment (equal to or less than 7 days in total) with insulin in connection with inter-current illness
4. History of chronic or idiopathic acute pancreatitis
5. Screening calcitonin value equal to or above 50 ng/L (pg/mL)
6. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2)
7. Impaired renal function defined as eGFR below 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate superiority of once-weekly dosing of two dose levels of semaglutide versus placebo on glycaemic control after 30 weeks of treatment in drug-naïve subjects with type 2 diabetes;Secondary Objective: To compare the effects of once-weekly dosing of two dose levels of semaglutide versus placebo after 30 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 30
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change in<br>1. Body weight<br>2. Fasting plasma glucose<br>3. Systolic and diastolic blood pressure<br><br>Subjects who achieve (yes/no):<br>4. HbA1c below 7.0% (53 mmol/mol) American Diabetes Association target<br>5. HbA1c equal to or below 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target;Timepoint(s) of evaluation of this end point: 1. + 2. + 3.: From baseline to week 30<br>4. + 5.: After 30 weeks' treatment