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

Novo Nordisk A/S271 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

271

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

Oral Glucose Tolerance Test (OGTT)OTHER

A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2

Euglycaemic hyperinsulinaemic clampOTHER

A 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3

Eligibility

Sex: ALLMin age: 40 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (2)

Novo Nordisk Investigational Site

København Ø, Denmark

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

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)

Time frame: At 5-hour Oral Glucose Tolerance Test (OGTT)

Secondary Outcomes

Insulin sensitivity estimated by a model-based analysis fit to the complete OGTT insulin and glucose profiles (12 time points)

Time frame: 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

Time frame: 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)

Time frame: At 5-hour OGTT and 4-hour clamp procedure

Data from ClinicalTrials.gov

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