Type 2 diabetes.
Conditions
Interventions
Acarbose used at a fixed dose of 50 mg. The daily maintenance dose was 50 mg tid, which was reached as from Week 3 after 2 weeks of up-titration with 50 mg od (Week 1) and 50 mg bid (Week 2).
Sponsors
Bayer medical B.V.
Eligibility
Inclusion criteria
Inclusion criteria: Persons with impaired glucose tolerance on the basis of two oral glucose tolerance tests (WHO '85) crietria).
Exclusion criteria
Exclusion criteria: Not having side effects of acarbose in the qualification period of 3 months. Persons having endocrinological diseases, or having a malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Venous plasma glucose level 2 hours after oral intake (in five minutes) of 75 g glucose dissolved in 300 ml water at study end (ie, after 3 years); A difference in 2h post-load glucose level between placebo and acarbose group of 0.5 mmol/L was regarded as being clinically relevant. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fasting venous glucose level; 2. Appearance of type 2 diabetes mellitus and normal glucose tolerance, according to WHO criteria; 3. b-cell function and insulin sensitivity as assessed via the method of the hyperglycemic clamp; 4. Level of cardiovascular risk factors: cholesterol, HDL-cholesterol, triglycerides, lipoprotein (a) (later deleted by amendment no. 4), albumin/creatinine ratio in time assessed urine sample. | — |
Contacts
Public ContactGiel Nijpels
VU University Medical Center, EMGO-Institute, Van der Boechorststraat 7
Outcome results
None listed