The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status. Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1...
Date First Received: February 22, 2008
Last Updated: March 5, 2008
Verified by: GWT-TUD GmbH, March 2008
Clinical Trial Phase: Phase 3 | Start Date:
Overall Status: Completed
Estimated Enrollment: 1429
Brief Summary
Official Title: “Metabolic Syndrome and Its Single Traits as Risk Factors of Diabetes in People With Impaired Glucose Tolerance: The STOP-NIDDM Trial”
Condition Keyword(s):
Intervention(s):
The aim of the study was to analyse the independent and joint effects of the components of the metabolic syndrome (MetS) on the incidence of diabetes in people with impaired glucose tolerance (IGT) and to assess the effect of acarbose by MetS status.
Double-blind placebo controlled trial, 1,368 patients, follow-up time 3.3 years. MetS by ATP III definition with fasting plasma glucose of ≥ 6.1 mmol/l as limit for impaired fasting glucose (IFG).
Study Type: Interventional
Study Design: Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: acarbose
- Drug: placebo
Arms, Groups and Cohorts in this Clinical Trial
- Active Comparator: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Incidence of newly diagnosed type 2 diabetes
Secondary Measures
- newly diagnosed hypertension
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- High risk population
- Age 40 to 70 yrs.
- BMI > 25 and < 40; FPG >5.5 mmol/l and < 7.8 mmol/l; IGT in OGGT
Exclusion Criteria:
- Known type 2 diabetes
- Drug intake affecting glucose tolerance
- Any cardiovascular events within the last 6 months
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: 70 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: GWT-TUD GmbH
Related Publications
References
Chiasson JL, Josse RG, Gomis R, Hanefeld M, Karasik A, Laakso M; STOP-NIDDM Trail Research Group. Acarbose for prevention of type 2 diabetes mellitus: the STOP-NIDDM randomised trial. Lancet. 2002 Jun 15;359(9323):2072-7.
Additional Information
Information obtained from ClinicalTrials.gov on August 29, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00629213
Study ID Number: Canadian: ACRI02; Bay g 5421
ClinicalTrials.gov Identifier: NCT00629213
Health Authority: Germany: Governmental Authority of Saxony, Regierungspraesidium Dresden
Clinical Trials Authorship and Review
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