Status:
COMPLETED
Early Diabetes Intervention Program
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Bayer
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
25-80 years
Phase:
PHASE4
Brief Summary
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
Detailed Description
A double blind, randomized, placebo-controlled clinical trial of acarbose in subjects with type 2 diabetes (an FDA-approved indication). Subjects were identified who had diabetes by glucose tolerance ...
Eligibility Criteria
Inclusion
- Fasting plasma glucose \<140 mg/dL
- 75 g OGTT 2hr glucose \>120 mg/dL
- BMI \> 25 OR history of gestational diabetes mellitus OR family history of type 2 diabetes
- Age at least 25 years
Exclusion
- Cancer within 5 years
- Chronic infectious disease (HIV, Hepatitis)
- CVD event within 6 months
- Uncontrolled hypertension or requiring beta blockers or thiazide diuretics for control
- elevated AST or ALT
- Serum creatinine \>1.4 mg/dL (men) or \>1.3 mg/dL (women)
- TG \>600 mg/dL
- Known glucosidase intolerance
- Inability to comply with protocol requirements.
Key Trial Info
Start Date :
February 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2004
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT01470937
Start Date
February 1 1998
End Date
September 1 2004
Last Update
November 11 2011
Active Locations (1)
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1
Indiana University Hospital GCRC
Indianapolis, Indiana, United States, 46202