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

Study Overview
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Brief Summary
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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).

Official Title
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Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: metformin
* Drug: placebo
* Drug: placebo
* Drug: glimepiride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170 + Met<br> | Drug: liraglutide<br>* Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously<br>Drug: metformin<br>* 1000 mg daily, administered orally<br>|
| Experimental: NNC 90-1170 + Met placebo<br> | Drug: placebo<br>* Metformin placebo administered orally. 1000 mg daily<br>|
| Placebo Comparator: Met + NNC 90-1170 placebo<br> | Drug: metformin<br>* 1000 mg daily, administered orally<br>Drug: placebo<br>* NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously<br>|
| Active Comparator: Met + Glim<br> | Drug: metformin<br>* 1000 mg daily, administered orally<br>Drug: glimepiride<br>* Individually adjusted dose, administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma/serum glucose |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Home monitored fasting plasma glucose |  |  | 
| Home monitored 7-point glucose profile |  |  | 
| Fructosamine |  |  | 
| Insulin |  |  | 
| C-peptide |  |  | 
| HbA1c (glycated haemoglobin A1c) |  |  | 
| Weight |  |  | 
| Beta-cell function and insulin resistance (HOMA model) |  |  | 
| Gastro-intestinal adverse events |  |  | 
| Other adverse events |  |  |