Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

Study Overview
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Brief Summary
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This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Official Title
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NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetic Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive) HbA1c maximum 10% based on analysis from central laboratory Exclusion Criteria: Cardiac problems Uncontrolled treated/untreated hypertension Proliferative retinopathy or known autonomic neuropathy Recurrent severe hypoglycemia 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 investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed Known or suspected abuse of alcohol or narcotics Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL Type 1 or other specific causes of diabetes

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: 0.045 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.225 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.45 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.60 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Experimental: 0.75 mg<br> | Drug: liraglutide<br>* Injected subcutaneously once daily<br>* Other names: NNC 90-1170;|
| Active Comparator: Met<br> | Drug: metformin<br>* 1000 mg twice daily, administered orally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG (fasting plasma glucose) |  |  | 
| HbA1c (glycosylated haemoglobin) |  |  | 
| Fructosamine |  |  | 
| Lipids |  |  | 
| Adverse events |  |  |