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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 23, 2014