The STOP-NIDDM Trial: An international study on the efficacy of an α-glucosidase inhibitor to prevent type 2 diabetes in a population with impaired glucose tolerance: rationale, design, and preliminary screening data

Jean-Louis Chiasson; Roman Gomis; Markolf Hanefeld; Robert G Josse; Avraham Karasik; Markku Laakso; The Stop-Niddm Trial Research Group

doi:10.2337/diacare.21.10.1720

Original Articles

The STOP-NIDDM Trial: An international study on the efficacy of an α-glucosidase inhibitor to prevent type 2 diabetes in a population with impaired glucose tolerance: rationale, design, and preliminary screening data

Jean-Louis Chiasson, MD,
Roman Gomis, MD,
Markolf Hanefeld, DSC,
Robert G Josse, MBBS,
Avraham Karasik, MD,
Markku Laakso, MD and
The Stop-Niddm Trial Research Group

Research Center, Centre Hospitalier de l'Université de Montréal, Campus Hôtel-Dieu, Department of Medicine, University of Toronto Toronto, Ontario, Canada
St. Michael's Hospital, Department of Medicine, University of Toronto Toronto, Ontario, Canada
Diabetes Unit, Hospital Clinic, Universitari de Barcelona Barcelona, Spain
Universitäts Klinikum Car Gustav Cams, der Technischen Uni Dresden Dresden, Germany
Institute of Endocrinology, Chaim Sheba Medical Center Tel Hashomer, Israel
Kuopio University Hospital Kuopio, Finland

Address correspondence and reprint requests to Jean-Louis Chiasson, MD, Director, Research Group on Diabetes and Metabolic Regulation, Research Center, CHUM, Campus Hôtel-Dieu, 3850 rue St. Urbain, Montreal (Quebec) H2W 1T8, Canada. E-mail: chiassoj{at}ere.umontreal.ca

Diabetes Care 1998 Oct; 21(10): 1720-1725. https://doi.org/10.2337/diacare.21.10.1720

Abstract

OBJECTIVE To describe the rationale and design, and to discuss the preliminary screening data, of the Study to Prevent NIDDM (STOP-NIDDM Trial), an international study on the efficacy of the α-glucosidase inhibitor acarbose in preventing or delaying the development of type 2 diabetes in a population with impaired glucose tolerance (IGT).

RESEARCH DESIGN AND METHODS A total of 1,418 subjects diagnosed with IGT according to the World Health Organization's criteria and having a fasting plasma glucose concentration ≥5.6 mmol/l were randomized in a double-blind fashion to receive either acarbose (100 mg t.i.d.) or placebo for a predictive median follow-up period of 3.9 years. The primary outcome is the development of type 2 diabetes diagnosed using a 75-g oral glucose tolerance test according to the new criteria. The secondary outcomes are changes in blood pressure, lipid profile, insulin sensitivity, cardiovascular events, and morphometric profile.

RESULTS Screening was performed in a high-risk population. As of 1 March 1997, 4,424 subjects had been screened, and data were available for 3,919 (88.5%) subjects. Of these subjects, 1,200 (30.6%) had glucose intolerance. Of the subjects with glucose intolerance, 521 (13.3%) had previously undetected type 2 diabetes, and 679 (17.3%) had IGT. Of the IGT population, 412 (60.7%) subjects were eligible for the study. This population had the following characteristics: the mean age was 54.8 years, 52% of the subjects were female, 53% had more than one risk factor for type 2 diabetes, >90% had a family history of diabetes, 78.2% had a BMI ≥27 kg/m², 47.5% had high blood pressure, 51.2% had dyslipidemia, and 22.8% of the women had a history of gestational diabetes.

CONCLUSIONS Screening of a high-risk population yields one eligible subject per every 10 volunteers screened. This study should definitely answer the question of whether acarbose can prevent or delay the progression of IGT to type 2 diabetes mellitus.