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

NCT ID: NCT00897169

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

Oral Glucose Tolerance Test (OGTT)

Intervention Type OTHER

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

B

Group Type EXPERIMENTAL

Oral Glucose Tolerance Test (OGTT)

Intervention Type OTHER

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

Euglycaemic hyperinsulinaemic clamp

Intervention Type OTHER

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

Interventions

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Oral Glucose Tolerance Test (OGTT)

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

Intervention Type OTHER

Euglycaemic hyperinsulinaemic clamp

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

København Ø, , Denmark

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Countries

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Denmark Japan

References

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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.

Reference Type DERIVED
PMID: 24130359 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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INS-3662

Identifier Type: -

Identifier Source: org_study_id