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Early Diabetes Intervention Program

NCT ID: NCT01470937

Last Updated: 2011-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2004-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acarbose

acarbose 100 mg once daily

Group Type EXPERIMENTAL

Acarbose

Intervention Type DRUG

acarbose 100 mg PO once daily

Placebo

Matched placebo was administered for acarbose 100 mg once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

acarbose placebo

Interventions

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Acarbose

acarbose 100 mg PO once daily

Intervention Type DRUG

Placebo

acarbose placebo

Intervention Type DRUG

Other Intervention Names

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Precose

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Indiana University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Kieren Mather

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kieren J Mather, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Robert V Considine, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Marian S Kirkman, MD

Role: STUDY_DIRECTOR

Indiana University

Locations

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Indiana University Hospital GCRC

Indianapolis, Indiana, United States

Site Status

Countries

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United States

References

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Kirkman MS, Shankar RR, Shankar S, Shen C, Brizendine E, Baron A, McGill J. Treating postprandial hyperglycemia does not appear to delay progression of early type 2 diabetes: the Early Diabetes Intervention Program. Diabetes Care. 2006 Sep;29(9):2095-101. doi: 10.2337/dc06-0061.

Reference Type RESULT
PMID: 16936159 (View on PubMed)

Patel YR, Kirkman MS, Considine RV, Hannon TS, Mather KJ. Changes in Weight and Glucose Can Protect Against Progression in Early Diabetes Independent of Improvements in beta-Cell Function. J Clin Endocrinol Metab. 2016 Nov;101(11):4076-4084. doi: 10.1210/jc.2016-2056. Epub 2016 Aug 17.

Reference Type DERIVED
PMID: 27533307 (View on PubMed)

Hannon TS, Kirkman MS, Patel YR, Considine RV, Mather KJ. Profound defects in beta-cell function in screen-detected type 2 diabetes are not improved with glucose-lowering treatment in the Early Diabetes Intervention Program (EDIP). Diabetes Metab Res Rev. 2014 Nov;30(8):767-76. doi: 10.1002/dmrr.2553.

Reference Type DERIVED
PMID: 24819707 (View on PubMed)

Other Identifiers

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9705-34

Identifier Type: -

Identifier Source: org_study_id