EDIP: Early Diabetes Intervention Program

Sponsor

Indiana University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01470937

Collaborator

Bayer (Industry)

219

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Acarbose Drug: Placebo	Phase 4

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

Actual Enrollment :

219 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Early Diabetes Intervention Program

Study Start Date :

Feb 1, 1998

Actual Primary Completion Date :

Sep 1, 2004

Actual Study Completion Date :

Sep 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Acarbose acarbose 100 mg once daily	Drug: Acarbose acarbose 100 mg PO once daily Other Names: Precose
Placebo Comparator: Placebo Matched placebo was administered for acarbose 100 mg once daily	Drug: Placebo acarbose placebo

Arm

Intervention/Treatment

Experimental: Acarbose

acarbose 100 mg once daily

Drug: Acarbose

acarbose 100 mg PO once daily

Other Names:

Precose

Placebo Comparator: Placebo

Matched placebo was administered for acarbose 100 mg once daily

Drug: Placebo

acarbose placebo

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Hospital GCRC	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

Indiana University School of Medicine
Bayer

Investigators

Principal Investigator: Kieren J Mather, MD, Indiana University
Principal Investigator: Robert V Considine, PhD, Indiana University
Study Director: Marian S Kirkman, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kieren Mather, Associate Professor of Medicine, Indiana University

ClinicalTrials.gov Identifier:

NCT01470937

Other Study ID Numbers:

9705-34

First Posted:

Nov 11, 2011

Last Update Posted:

Nov 11, 2011

Last Verified:

Nov 1, 2011

Keywords provided by Kieren Mather, Associate Professor of Medicine, Indiana University

diabetes acarbose alphaglucosidase prevention

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Acarbose

Study Results

No Results Posted as of Nov 11, 2011