Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
OTHEROral Glucose Tolerance Test (OGTT)
A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2
OTHEREuglycaemic hyperinsulinaemic clamp
A 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Denmark, Japan
Outcome results
None listed