Early Diabetes Intervention Program

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University School of Medicine
• Collaborator: Bayer
• Treatments: Acarbose

Criteria

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.