Early Diabetes Intervention Program (EDIP)

Indiana University School of Medicine

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: Acarbose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01470937

9705-34

Details and patient eligibility

About

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

Full 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.

Enrollment: 219 patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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219 participants in 2 patient groups, including a placebo group

Acarbose

Experimental group

Description:

acarbose 100 mg once daily

Treatment:

Drug: Acarbose

Placebo

Placebo Comparator group

Description:

Matched placebo was administered for acarbose 100 mg once daily

Treatment:

Drug: Placebo