Skip to main content
OpenTrials
Completed

NCT Number: NCT01470937

Early Diabetes Intervention Program

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Indiana University Hospital GCRC

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acarbose

Drug

acarbose 100 mg PO once daily

Other names: Precose

Placebo

Drug

acarbose placebo

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Bayer

Registry information

Acronym: EDIP

Important dates

Study start
1998
Primary completion
2004
Study completion
2004
First posted
Nov 11, 2011
Registry last updated
Nov 11, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.