A Trial Investigating the Possible Difference in Development of Type 2 Diabetes Between Caucasian and Japanese Subjects

Study Overview
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Brief Summary
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This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects with type 2 diabetes will be included in the trial. The development of type 2 diabetes across the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.

Official Title
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A Trial Investigating the Possible Difference in the Development of Type 2 Diabetes in Caucasian and Japanese Subjects by a Model-based Analysis

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Other: Oral Glucose Tolerance Test (OGTT)
* Other: Euglycaemic hyperinsulinaemic clamp


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Danish (Northern European) or Japanese (according to country allocation) background for at least 3 generations BMI above or equal to 18 kg/m2 Exclusion Criteria: Treatment of diabetes mellitus with any insulin product Fasting plasma/serum glucose above 12 mM Therapy with TZD (thiazolidinedione) drugs within the past 3 months Therapy with more than 2 OADs (oral anti-diabetics drugs)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Other: Oral Glucose Tolerance Test (OGTT)<br>* A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2<br>|
| Experimental: B<br> | Other: Oral Glucose Tolerance Test (OGTT)<br>* A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2<br>Other: Euglycaemic hyperinsulinaemic clamp<br>* A 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beta-cell function index estimated by a model-based analysis fit to the complete OGTT C-peptide and glucose profiles (12 time points), and including diabetes progression (as assessed by the glucose concentration 2 hours after an oral glucose load) |  | At 5-hour Oral Glucose Tolerance Test (OGTT) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity estimated by a model-based analysis fit to the complete OGTT insulin and glucose profiles (12 time points) |  | At 5-hour OGTT and 4-hour clamp procedure | 
| Fraction of the possible difference in ß-cell function and insulin sensitivity between Japanese and Caucasian that can be explained by each covariate factor |  | At 5-hour OGTT and 4-hour clamp procedure | 
| Evaluation of comparability of OGTT and clamp data based on modelling data of insulin sensitivity from steady-state clamp insulin and glucose concentrations and OGTT insulin and glucose profiles (12 time points) |  | At 5-hour OGTT and 4-hour clamp procedure |