Effect of Liraglutide on the Beta-cell Responsiveness in Subjects With Type 2 Diabetes Compared to a Healthy Control Group

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 assess the effect of NNC 90-1170 on beta-cell responsiveness to increasing blood glucose concentrations in subjects with type 2 diabetes.

Official Title
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NNC 90-1170 Mechanism of Action: A Double-blind, Randomized, Single-center, Placebo Controlled, Crossover Study to Examine Beta-cell Responsiveness to Graded Glucose Infusion in Subjects With Type 2 Diabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: liraglutide
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with type 2 diabetes, either newly diagnosed with at least 2 months of diet or on OAD monotherapy for at least 3 months Body Mass Index (BMI): 24-35 kg/m^2 inclusive Exclusion Criteria: SUBJECTS WITH TYPE 2 DIABETES Receipt of any investigational drug within three months prior to this trial Recurrent severe hypoglycemia as judged by the investigator Cardiac disease Use of any drug (except an OAD (oral anti-diabetic drug)) that in the investigator's opinion could interfere with the blood glucose level Haemoglobin maximum 10 g/L HbA1c above 12% Loss of more than 400 mL blood during the 3 months prior to trial start HEALTHY SUBJECTS Receipt of any investigational drug within 3 months prior to this trial Clinically relevant cardiac disease or any clinically significant abnormal ECG (electrocardiogram) Use of any drug that in the investigator's opinion could interfere with the blood glucose level Haemoglobin max. 10 g/L HbA1c at least 6%

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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170<br> | Drug: liraglutide<br>* A single dose of 7.5 mcg/kg administered subcutaneously in random order<br>* Other names: NNC 90-1170;Drug: placebo<br>* A single dose administered subcutaneously in random order<br>|
| Placebo Comparator: Placebo<br> | Drug: liraglutide<br>* A single dose of 7.5 mcg/kg administered subcutaneously in random order<br>* Other names: NNC 90-1170;Drug: placebo<br>* A single dose administered subcutaneously in random order<br>|
| No Intervention: Healthy<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (area under the curve) of Insulin Secretion Rate (ISR) over the 90-216 mg/dL glucose interval |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slope of the mean ISR vs mean glucose |  |  | 
| AUC (area under the curve) of glucagon concentration over the 90-216 mg/dL glucose interval |  |  | 
| Insulin Clearance |  |  | 
| NNC 90-1 170 plasma concentration |  |  | 
| Adverse events |  |  |