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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00897169

INS-3662

Details and patient eligibility

About

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.

Enrollment: 271 patients

Sex: All

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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271 participants in 2 patient groups

A

Experimental group

Treatment:

Other: Oral Glucose Tolerance Test (OGTT)

B

Experimental group

Treatment:

Other: Oral Glucose Tolerance Test (OGTT)

Other: Euglycaemic hyperinsulinaemic clamp