Early Diabetes Intervention Program

Type 2 Diabetes Mellitus Clinical Trial

— EDIP  

Official title:

Early Diabetes Intervention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470937
• Other study ID #: 9705-34
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2011
• Last updated: November 10, 2011
• Start date: February 1998
• Est. completion date: September 2004

Study information

• Verified date: November 2011
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Acarbose
acarbose 100 mg PO once daily
• Placebo
acarbose placebo

Locations

Country	Name	City	State
United States	Indiana University Hospital GCRC	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From date of randomization until the date of first documented progression or censoring, up to 5 years post randomization	No