Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
10/03/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Giel Nijpels

ORCID ID

Contact details

Department of general practice
EMGO Institute
VU University Medical Center
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 4449659
g.nijpels@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

DAISI

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Screening

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

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

Overall trial start date

01/06/1996

Overall trial end date

01/01/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Persons with impaired glucose tolerance on the basis of two oral glucose tolerance tests (World Health Organization [WHO] 1985 criteria).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

119

Participant 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

Recruitment start date

01/06/1996

Recruitment end date

01/01/2000

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of general practice
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Bayer Medical B.V. (The Netherlands)

Sponsor details

P.O. Box 80
Mijdrecht
3640 AB
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Not defined

Funder name

Not provided at time of registration

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes