|- candidate number||1251|
|- NTR Number||NTR150|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||26-aug-2005|
|- Secondary IDs||N/A |
|- Public Title||Dutch Acarbose Intervention Trial (DAISI).|
|- Scientific Title||Dutch Acarbose Intervention Trial.|
|- hypothesis||Approximately 1/3 of persons with IGT develops type 2 diabetes mellitus in 5-10 years time. Acarbose is an alpha-glucosidase inhibitor decreasing post-prandial glucose levels, without the risk of hypoglycemia. The prevention of diabetes with acarbose in this study was considered a feasible approach.|
|- Healt Condition(s) or Problem(s) studied||Diabetes Mellitus Type 2 (DM type II)|
|- Inclusion criteria||Persons with impaired glucose tolerance on the basis of two oral glucose tolerance tests (WHO '85) crietria).|
|- Exclusion criteria||Not having side effects of acarbose in the qualification period of 3 months. Persons having endocrinological diseases, or having a malignancy.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-1996|
|- planned closingdate||1-jan-2000|
|- Target number of participants||119|
|- 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).|
|- Primary outcome||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 outcome||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.
|- Trial web site||N/A|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES||Dr. Giel Nijpels|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Giel Nijpels|
|- Sponsor/Initiator ||Bayer medical B.V.|
(Source(s) of Monetary or Material Support)
|- Brief summary||A total of 171 subjects were screened and 121 subjects with impaired glucose tolerance were included in the randomized, double-blind and placebo-controlled treatment phase over 3 years (60 placebo and 61 acarbose). |
33 subjects under placebo and 27 subjects under acarbose completed the study. All randomized subjects were included in the safety population, 118 subjects (58 placebo, 60 acarbose) in the ITT population and 71 subjects (39 placebo, 32 acarbose) in the PP population.
Median age of subjects in the safety population was 56 years (placebo) and 61 years (acarbose), respectively. The sex ratio in each of the treatment groups was nearly 1:1.
Descriptively, the mean post-load glucose value after 3 years of treatment was slightly lower among subjects under acarbose compared with placebo, but in all analyzed parameters of glucose metabolism - including the oGGT data, the results derived from the hyperglycemic clamp, and the conversion rates- there appeared to be no clear and relevant differences between treatment groups.
|- Main changes (audit trail)|
|- RECORD||19-aug-2005 - 15-mei-2008|