NCT01470937

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Feb 1998

Longer than P75 for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1998

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
7.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 11, 2011

Completed
Last Updated

November 11, 2011

Status Verified

November 1, 2011

Enrollment Period

6.6 years

First QC Date

October 27, 2011

Last Update Submit

November 10, 2011

Conditions

Type 2 Diabetes Mellitus

Keywords

diabetes acarbose alphaglucosidase prevention

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Acarbose

EXPERIMENTAL

acarbose 100 mg once daily

Drug: Acarbose

Placebo

PLACEBO COMPARATOR

Matched placebo was administered for acarbose 100 mg once daily

Drug: Placebo

Interventions

AcarboseDRUG

acarbose 100 mg PO once daily

Also known as: Precose
Acarbose
PlaceboDRUG

acarbose placebo

Placebo

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fasting plasma glucose \<140 mg/dL
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital GCRC

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

  • 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.

    PMID: 16936159RESULT

  • 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.

    PMID: 27533307DERIVED

  • 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.

    PMID: 24819707DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acarbose

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TrisaccharidesOligosaccharidesPolysaccharidesCarbohydrates

Study Officials

  • Kieren J Mather, MD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Robert V Considine, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

  • Marian S Kirkman, MD

    Indiana University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

October 27, 2011

First Posted

November 11, 2011

Study Start

February 1, 1998

Primary Completion

September 1, 2004

Study Completion

September 1, 2004

Last Updated

November 11, 2011

Record last verified: 2011-11

Locations

US(1)