NCT00521742

Brief Summary

The purpose of this study is to evaluate the cardiovascular effects of pioglitazone, once daily (QD), versus glyburide when administered to patients with type 2 diabetes mellitus and mild cardiac disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus

Timeline
Completed

Started Mar 2001

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

March 1, 2001

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2007

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

1.8 years

First QC Date

August 25, 2007

Last Update Submit

February 27, 2012

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism DisorderDysmetabolic SyndromeType II DiabetesDiabetes Mellitus, LipoatrophicDyslipidemiaDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Change in the walking distance during a standardized 6-minute walk test.

    Weeks 2, 16, 24, 40, and 52 or Final Visit

Secondary Outcomes (10)

  • Morbidity and Mortality Due to Cardiovascular Events.

    At occurrence or Weeks 2, 4, 6, 8, 12, 16, 24, 32, 36, 40, 48, and 52 or Final Visit

  • Change in Cardiovascular Treatment Program.

    At occurrence or Weeks 2, 4, 6, 8, 12, 16, 24, 32, 36, 40, 48, and 52 or Final Visit

  • Change from Baseline in 12-lead Electrocardiogram Parameter (Ventricular Heart Rate)

    Weeks 24 and 52 or Final Visit

  • Change from Baseline in Electrocardiogram Parameter (Left Ventricular Mass)

    Week 52 or Final Visit

  • Change from Baseline in Electrocardiogram Parameter (Left Ventricular Ejection Fraction)

    Week 52 or Final Visit

  • +5 more secondary outcomes

Study Arms (4)

Pioglitazone 15 mg to 45 mg QD

EXPERIMENTAL
Drug: Pioglitazone

Glyburide 2.5 mg to 15 mg, QD

ACTIVE COMPARATOR
Drug: Glyburide

Pioglitazone 15 mg or 30 mg QD

EXPERIMENTAL
Drug: Pioglitazone

Glyburide 5 mg or 10 mg, QD

ACTIVE COMPARATOR
Drug: Glyburide

Interventions

PioglitazoneDRUG

Pioglitazone 15 mg to 45 mg, tablets, orally, once daily and glyburide placebo-matching capsules, orally, once daily for up to 52 weeks.

Also known as: Actos, AD4833
Pioglitazone 15 mg to 45 mg QD
GlyburideDRUG

Glyburide 2.5 mg to 15 mg, capsules, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 52 weeks.

Glyburide 2.5 mg to 15 mg, QD

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.
  • Diagnosed with type 2 diabetes mellitus.
  • Naive to oral antidiabetic pharmacologic therapy, who were currently taking sulfonylurea monotherapy, who were currently taking sulfonylurea/metformin combination therapy, or who were currently taking metformin monotherapy.
  • Mild cardiac disease New York Heart Association functional Class I.
  • Participated in dietary counseling.
  • Glycosylated hemoglobin greater than or equal to 7.5% and less than 12% at Screening if naïve to oral antidiabetic pharmacologic therapy or taking metformin monotherapy, or greater than or equal to 6.5% and less than 12% if currently taking sulfonylurea monotherapy or taking ulfonylurea/metformin combination therapy.
  • Stable therapy for cardiovascular dysfunction, defined as no change in therapy for greater than or equal to 4 weeks prior to Randomization.

You may not qualify if:

  • Within the past 30 days treated with rosiglitazone, pioglitazone, or troglitazone or those previously treated with rosiglitazone, pioglitazone, or troglitazone but discontinued from therapy because of lack of efficacy or clinical or laboratory signs of intolerance.
  • Treated with a sulfonylurea but discontinued for lack of efficacy or clinical or laboratory intolerance.
  • Currently taking insulin or on continuous insulin therapy for control of their diabetes
  • Type 1 (insulin-dependent) diabetes mellitus or a history of ketoacidosis.
  • Any other investigational drug during the 30 days prior to Visit 1 or who will receive such a drug during the time-frame of this study.
  • History of chronic alcoholism or drug abuse during the 6 months prior to the study.
  • New York Heart Association functional Class II, III, or IV cardiac disease at Screening, or previous history of Class III or IV.
  • Any of the following:
  • myocardial infarction
  • coronary angioplasty or bypass graft
  • unstable angina pectoris
  • transient ischemic attacks
  • documented cerebrovascular accident. 9. Abdominal, thoracic, or vascular surgery during the 3 months prior to Visit 1.
  • Planned surgical or catheterization intervention within 6 months following Visit 1.
  • Awaiting cardiac transplantation.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Giles TD, Elkayam U, Bhattacharya M, Perez A, Miller AB. Comparison of pioglitazone vs glyburide in early heart failure: insights from a randomized controlled study of patients with type 2 diabetes and mild cardiac disease. Congest Heart Fail. 2010 May-Jun;16(3):111-7. doi: 10.1111/j.1751-7133.2010.00154.x.

    PMID: 20557330RESULT

Related Links

MeSH Terms

Conditions

Diabetes MellitusGlucose Metabolism DisordersDiabetes Mellitus, Type 2Diabetes Mellitus, LipoatrophicDyslipidemias

Interventions

PioglitazoneGlyburide

Condition Hierarchy (Ancestors)

Metabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsSulfonylurea CompoundsUreaAmidesSulfones

Study Officials

  • VP Clinical Science Strategy

    Takeda Global Research and Developmnet Center Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2007

First Posted

August 28, 2007

Study Start

March 1, 2001

Primary Completion

January 1, 2003

Study Completion

January 1, 2003

Last Updated

February 28, 2012

Record last verified: 2012-02