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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00897169
First received: February 24, 2009
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Other: Oral Glucose Tolerance Test (OGTT)
Other: Euglycaemic hyperinsulinaemic clamp
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Trial Investigating the Possible Difference in the Development of Type 2 Diabetes in Caucasian and Japanese Subjects by a Model-based Analysis

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 320
Study Start Date: June 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00897169

Locations
Denmark
København ø, Denmark, 2100
Japan
Tokyo, Japan, 113-8655
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Hanne Hvidberg, M.Sc. Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00897169     History of Changes
Other Study ID Numbers: INS-3662
Study First Received: February 24, 2009
Last Updated: March 26, 2014
Health Authority: Denmark: Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014