Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes
Phase 2
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01509755
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe. The aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of NNC90-1170.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 196
Inclusion Criteria
- Subjects with type 2 diabetes
- Duration of diabetes at least 3 months
- Both diet treated and patients in therapy with OHA (oral hypoglycemic agents)
- Body Mass Index maximum 40 kg/m^2
- HbA1c based on analysis from central laboratory: Between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for OHA treated
Exclusion Criteria
- Liver or renal disease
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Proliferative retinopathy
- Recurrent severe hypoglycaemia as judged by the Investigator
- Known or suspected allergy to trial product or related products
- Use of any drug (except for OHAs) which in the Investigator's opinion could interfere with the blood glucose level
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Glim placebo - Glim glimepiride - Placebo placebo - 0.045 mg liraglutide - 0.225 mg liraglutide - 0.45 mg liraglutide - 0.60 mg liraglutide - 0.75 mg liraglutide -
- Primary Outcome Measures
Name Time Method HbA1c (glycosylated haemoglobin)
- Secondary Outcome Measures
Name Time Method Fasting plasma glucose 7-point blood glucose profile Adverse events Fructosamine
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Worksop, United Kingdom