Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes
Phase 2
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 2
- Interventions
- Registration Number
- NCT01511172
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 145
Inclusion Criteria
- Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
- Duration of type 2 diabetes diagnosis at least one year
- HbA1c 8.0-13.0%, both inclusive
- Body Mass Index (BMI) between 25-40 kg/m^2, both inclusive.
Exclusion Criteria
- Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
- Impaired liver function
- Impaired renal function
- Cardiac problems
- Uncontrolled treated/untreated hypertension
- Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
- Recurrent major 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 glucose level
- Known or suspected abuse of alcohol or narcotics
- Any contraindications to metformin or glimepiride according to the local guidelines
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NNC 90-1170 + Met liraglutide - Met + NNC 90-1170 placebo metformin - NNC 90-1170 + Met metformin - NNC 90-1170 + Met placebo placebo - Met + NNC 90-1170 placebo placebo - Met + Glim glimepiride - Met + Glim metformin -
- Primary Outcome Measures
Name Time Method Fasting plasma/serum glucose
- Secondary Outcome Measures
Name Time Method Insulin Fructosamine Home monitored fasting plasma glucose C-peptide Home monitored 7-point glucose profile HbA1c (glycated haemoglobin A1c) Weight Beta-cell function and insulin resistance (HOMA model) Gastro-intestinal adverse events Other adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇬🇧Yaxley. Peterborough, United Kingdom