NCT00897169

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
271

participants targeted

Target at P75+ for phase_1 diabetes

Timeline
Completed

Started Jun 2009

Longer than P75 for phase_1 diabetes

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
20 days until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 27, 2016

Status Verified

October 1, 2016

Enrollment Period

1.5 years

First QC Date

February 24, 2009

Last Update Submit

October 26, 2016

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

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)

    At 5-hour Oral Glucose Tolerance Test (OGTT)

Secondary Outcomes (3)

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

    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

    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)

    At 5-hour OGTT and 4-hour clamp procedure

Study Arms (2)

A

EXPERIMENTAL
Other: Oral Glucose Tolerance Test (OGTT)

B

EXPERIMENTAL
Other: Oral Glucose Tolerance Test (OGTT)Other: Euglycaemic hyperinsulinaemic clamp

Interventions

Oral Glucose Tolerance Test (OGTT)OTHER

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

AB
Euglycaemic hyperinsulinaemic clampOTHER

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

B

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Danish (Northern European) or Japanese (according to country allocation) background for at least 3 generations
  • BMI above or equal to 18 kg/m2

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novo Nordisk Investigational Site

København Ø, 2100, Denmark

Location

Novo Nordisk Investigational Site

Tokyo, 113-8655, Japan

Location

Related Publications (1)

  • Moller JB, Pedersen M, Tanaka H, Ohsugi M, Overgaard RV, Lynge J, Almind K, Vasconcelos NM, Poulsen P, Keller C, Ueki K, Ingwersen SH, Pedersen BK, Kadowaki T. Body composition is the main determinant for the difference in type 2 diabetes pathophysiology between Japanese and Caucasians. Diabetes Care. 2014;37(3):796-804. doi: 10.2337/dc13-0598. Epub 2013 Oct 15.

    PMID: 24130359DERIVED

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Glucose Tolerance Test

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative Techniques

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2009

First Posted

May 12, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 27, 2016

Record last verified: 2016-10

Locations

JP(1)DK(1)