Early Diabetes Intervention Program

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: Acarbose

• Registration Number: NCT01470937
• Lead Sponsor: Indiana University School of Medicine

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 Timeline

• Study Start: 1998-02
• Primary Completion: 2004-09
• Study Completion: 2004-09
• Study First Submitted: 2011-10-27
• Status Verified: 2011-11
• Study First Submitted QC: 2011-11-10
• Last Update Submitted: 2011-11-10
• Study First Posted: 2011-11-11
• Last Update Posted: 2011-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Matched placebo was administered for acarbose 100 mg once daily
Acarbose	Acarbose	acarbose 100 mg once daily

Primary Outcome Measures

Name	Time	Method
Progression of fasting glucose >140 mg/dL	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.

Trial Locations

Locations (1)

Indiana University Hospital GCRC; 🇺🇸 Indianapolis, Indiana, United States