Early Diabetes Intervention Program
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- Progression of fasting glucose >140 mg/dL
Study Overview
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 test criteria but non-diabetic fasting glucose concentrations. Treatment interventions were assessed for their ability to delay worsening of fasting glucose control.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
Acarbose
acarbose 100 mg once daily
Intervention: Acarbose (Drug)
Placebo
Matched placebo was administered for acarbose 100 mg once daily
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Progression of fasting glucose >140 mg/dL
Time Frame: From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization
Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression.
Secondary Outcomes
No secondary outcomes reported
Investigators
Kieren Mather
Associate Professor of Medicine
Indiana University