Dutch Acarbose Intervention Trial (DAISI)

ISRCTN	ISRCTN33274262
DOI	https://doi.org/10.1186/ISRCTN33274262
Protocol serial number	N/A
Sponsor	Bayer Medical B.V. (The Netherlands)
Funder	Not provided at time of registration

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 10/03/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Giel Nijpels
Scientific

Department of general practice
EMGO Institute
VU University Medical Center
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 4449659
Email	g.nijpels@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	DAISI
Study objectives	Approximately 1/3 of persons with impaired glucose tolerance (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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Diabetes Mellitus type II (DM type II)
Intervention	Acarbose used at a fixed dose of 50 mg. The daily maintenance dose was 50 mg three times a day (tid), which was reached as from week 3 after two weeks of up-titration with 50 mg once a day (od) (week 1) and 50 mg twice daily (bid) (week 2).
Intervention type	Other
Primary outcome measure(s)	Venous plasma glucose level two hours after oral intake (in five minutes) of 75 g glucose dissolved in 300 ml water at study end (ie, after three years). A difference in two hour post-load glucose level between placebo and acarbose group of 0.5 mmol/L was regarded as being clinically relevant.
Key secondary outcome measure(s)	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 hyperglycaemic clamp 4. Level of cardiovascular risk factors: cholesterol, high density lipoprotein (HDL)cholesterol, triglycerides, lipoprotein (a) (later deleted by amendment no. 4), albumin/creatinine ratio in time assessed urine sample
Completion date	01/01/2000

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	119
Key inclusion criteria	Persons with impaired glucose tolerance on the basis of two oral glucose tolerance tests (World Health Organization [WHO] 1985 criteria).
Key exclusion criteria	1. Not having side effects of acarbose in the qualification period of three months 2. Persons having endocrinological diseases, or having a malignancy
Date of first enrolment	01/06/1996
Date of final enrolment	01/01/2000

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of general practice

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan