Early Diabetes Intervention Program (EDIP)
November 10, 2011 updated by: Kieren Mather, Indiana University School of Medicine
This is an evaluation of the effect of acarbose to delay worsening of fasting glucose control in early Type 2 diabetes mellitus.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
219
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University Hospital GCRC
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acarbose
acarbose 100 mg once daily
|
acarbose 100 mg PO once daily
Other Names:
|
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Placebo Comparator: Placebo
Matched placebo was administered for acarbose 100 mg once daily
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acarbose placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression of fasting glucose >140 mg/dL
Time Frame: 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.
|
From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 1998
Primary Completion (Actual)
September 1, 2004
Study Completion (Actual)
September 1, 2004
Study Registration Dates
First Submitted
October 27, 2011
First Submitted That Met QC Criteria
November 10, 2011
First Posted (Estimate)
November 11, 2011
Study Record Updates
Last Update Posted (Estimate)
November 11, 2011
Last Update Submitted That Met QC Criteria
November 10, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9705-34
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.