Early Diabetes Intervention Program

Early Diabetes Intervention Program

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

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.

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.