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Early Diabetes Intervention Program (EDIP)

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Acarbose

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes acarbose alphaglucosidase prevention

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Indiana University Hospital GCRC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Acarbose

Placebo

Arm Description

acarbose 100 mg once daily

Matched placebo was administered for acarbose 100 mg once daily

Outcomes

Primary Outcome Measures

Progression of fasting glucose >140 mg/dL

Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression.

Secondary Outcome Measures

Full Information

NCT ID

NCT01470937

First Posted

October 27, 2011

Last Updated

November 10, 2011

Sponsor

Indiana University School of Medicine

Collaborators

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01470937

Brief Title

Early Diabetes Intervention Program

Acronym

EDIP

Official Title

Early Diabetes Intervention Program

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

February 1998 (undefined)

Primary Completion Date

September 2004 (Actual)

Study Completion Date

September 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University School of Medicine

Collaborators

Bayer

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

Keywords

diabetes acarbose alphaglucosidase prevention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

219 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acarbose

Arm Type

Experimental

Arm Description

acarbose 100 mg once daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matched placebo was administered for acarbose 100 mg once daily

Intervention Type

Drug

Intervention Name(s)

Acarbose

Other Intervention Name(s)

Precose

Intervention Description

acarbose 100 mg PO once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

acarbose placebo

Primary Outcome Measure Information:

Title

Progression of fasting glucose >140 mg/dL

Description

Fasting plasma glucose was measured quarterly for up to 5 years. Two consecutive measures above 140 mg/dL defined progression.

Time Frame

From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kieren J Mather, MD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Robert V Considine, PhD

Organizational Affiliation

Indiana University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Marian S Kirkman, MD

Organizational Affiliation

Indiana University

Official's Role

Study Director

Facility Information:

Facility Name

Indiana University Hospital GCRC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

16936159

Citation

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.

Results Reference

result

PubMed Identifier

27533307

Citation

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.

Results Reference

derived

PubMed Identifier

24819707

Citation

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.

Results Reference

derived

Learn more about this trial

Early Diabetes Intervention Program

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