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

October 26, 2016 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

271

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • København ø, Denmark, 2100
        • Novo Nordisk Investigational Site
  • Japan
      • Tokyo, Japan, 113-8655
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: At 5-hour Oral Glucose Tolerance Test (OGTT)
At 5-hour Oral Glucose Tolerance Test (OGTT)

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
At 5-hour OGTT and 4-hour clamp procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 24, 2009

First Submitted That Met QC Criteria

May 11, 2009

First Posted (Estimate)

May 12, 2009

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3662

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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