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

Phase 1

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Other: Oral Glucose Tolerance Test (OGTT); Other: Euglycaemic hyperinsulinaemic clamp

• Registration Number: NCT00897169
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-02-24
• Study First Submitted QC: 2009-05-11
• Study First Posted: 2009-05-12
• Study Start: 2009-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 271

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Oral Glucose Tolerance Test (OGTT)	-
B	Oral Glucose Tolerance Test (OGTT)	-
B	Euglycaemic hyperinsulinaemic clamp	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇯🇵 Tokyo, Japan