Skip to main content
OpenTrials
Completed

NCT Number: NCT00897169

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, København Ø, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

oral glucose tolerance test (OGTT)

Other

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

Euglycaemic hyperinsulinaemic clamp

Other

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

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 12, 2009
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.