Comparison of Liraglutide and Glimepiride on Blood Sugar Control in Subjects With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Dose-response Relationship of Five Dose Levels of NNC90-1170 and Placebo on Glycaemic Control in Type 2 Diabetic Patients Compared to OHA Treatment. A 12-week Multi-centre, Double-blind, Randomised, Parallel Group Trial With an Open Labelled OHA Arm

Conditions
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Diabetes, Diabetes Mellitus, Type 2

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>|
| Experimental: 0.045 mg<br> | Drug: liraglutide<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>* Other names: NNC 90-1170;|
| Experimental: 0.225 mg<br> | Drug: liraglutide<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>* Other names: NNC 90-1170;|
| Experimental: 0.45 mg<br> | Drug: liraglutide<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>* Other names: NNC 90-1170;|
| Experimental: 0.60 mg<br> | Drug: liraglutide<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>* Other names: NNC 90-1170;|
| Experimental: 0.75 mg<br> | Drug: liraglutide<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>* Other names: NNC 90-1170;|
| Active Comparator: Glim<br> | Drug: placebo<br>* Once daily injection, under the skin (s.c.) for 12 weeks<br>Drug: glimepiride<br>* Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c (glycosylated haemoglobin) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose |  |  | 
| Fructosamine |  |  | 
| 7-point blood glucose profile |  |  | 
| Adverse events |  |  |