Safety Comparison of Pioglitazone and Glyburide in Type 2 Diabetes Subjects With Mild to Moderate Congestive Heart Failure

NCT00521820 | Terminated Phase 3 DMC

• 2 other identifiers: 01-00-TL-OPI-504U1111-1114-1029
• Study Type: interventional
• Target: 518
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the safety of Pioglitazone, once daily (QD), to Glyburide in Type 2 Diabetes Subjects with Mild to Moderate Congestive Heart Failure

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Progression of Congestive Heart Failure.

  At First Event.

Secondary Outcomes (10)

• Change from baseline in Glycosylated Hemoglobin.

  Weeks 12, 20 and Final Visit.

• Change from baseline in Fasting Plasma Glucose.

  At All Visits.

• Change from baseline in Triglycerides.

  Weeks 8, 16 and Final Visit.

• Change from baseline in cholesterol (total cholesterol, high-density lipoprotein and low-density lipoprotein).

  Weeks 8, 16 and Final Visit.

• Change from baseline in 6 Minute Walking test distance

  At Final Visit

Study Arms (2)

Pioglitazone QD

EXPERIMENTAL

Drug: Pioglitazone

Glyburide QD

ACTIVE COMPARATOR

Drug: Glyburide

Interventions

Pioglitazone DRUG

Pioglitazone 30 mg (titrated to 45mg with tolerance), tablets, orally once daily and glyburide placebo-matching tablets, orally, once daily for up to 24 weeks.

Also known as: Actos, AD-4833

Pioglitazone QD

Glyburide DRUG

Pioglitazone placebo-matching tablets, orally, once daily and glyburide 10 mg (titrated to 15mg with tolerance), capsules, orally, once daily for up to 24 weeks.

Glyburide QD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females of childbearing potential must be using appropriate birth during the entire duration of the study or must be surgically sterile.
• Subjects with a clear diagnosis of type 2 diabetes mellitus using diagnostic criteria of the American Diabetes Association who have been taking a sulfonylurea and/or insulin for at least 30 days prior to Visit 1 or who have been withdrawn from metformin therapy, during the 30 days prior to Visit 1, due to congestive heart failure.
• Subjects with a clinical diagnosis of congestive heart failure, New York Heart Association Class II or early Class III. Subjects should not previously have been in Class IV heart failure.
• Diagnosis of left ventricular congestive heart failure as evidenced by a left ventricular ejection fraction less than 40% at screening based on an echocardiogram.
• Subjects who have demonstrated the need for oral hypoglycemic agents and have participated in dietary counseling.
• Glycosylated hemoglobin greater than 7.0% at screening.
• Subjects on optimal therapy for congestive heart failure. Medication doses should be stable for at least two weeks prior to randomization.

You may not qualify if:

• Naïve to antidiabetic therapy.
• Within the past three months were treated with rosiglitazone, pioglitazone HCl, or troglitazone or those previously treated with rosiglitazone, pioglitazone HCl, or troglitazone but discontinued from therapy due to lack of efficacy or clinical or laboratory signs of intolerance.
• Type 1 (insulin-dependent) diabetes mellitus or a history of ketoacidosis.
• Has taken any other investigational drug during the 30 days prior to Visit 1 or who will receive such a drug during the timeframe of this study.
• History of chronic alcoholism or drug abuse during the six months prior to the study.
• Subjects with a planned surgical or catheterization intervention within the six months following Visit 1.
• Subjects awaiting cardiac transplantation.
• Intercurrent illness severe enough to require hospitalization during the three weeks prior to Visit 1.
• Body mass index greater than 48 kg/m2 as calculated by \[Weight (kg)/Height (m)2\].
• Anemia having a hemoglobin less than 10.5 g/dL for males and less than 10 g/dL for females.
• Thyroid stimulating hormone greater than 3.5 mU/L or less than 0.3 mU/L. The thyroid stimulating hormone can be repeated at two months. The subject is eligible if the screening thyroid stimulating hormone is elevated, and the repeat value at two months is less than 3.5 mU/L.
• Triglyceride level greater than 500 mg/dL.
• Clinical evidence of active liver disease or alanine transaminase levels greater than 1.5 times the upper limit of normal.
• Serum creatinine greater than 2.0 mg/dL for males and greater than 1.8 mg/dL for females or urinalysis protein (albumin) excretion greater than 2 plus on Combistix or equivalent (if elevated, may be re-screened in one month).
• Systolic blood pressure of greater than 150 mmHg or diastolic blood pressure greater than 100 mmHg.

Sponsors & Collaborators

• Takeda: lead

Related Publications (1)

• Giles TD, Miller AB, Elkayam U, Bhattacharya M, Perez A. Pioglitazone and heart failure: results from a controlled study in patients with type 2 diabetes mellitus and systolic dysfunction. J Card Fail. 2008 Aug;14(6):445-52. doi: 10.1016/j.cardfail.2008.02.007. Epub 2008 May 27.

  PMID: 18672190 RESULT

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Dyslipidemias

Interventions

Pioglitazone; Glyburide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonylurea Compounds; Urea; Amides; Sulfones

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: June 1, 2000
• Primary Completion: October 1, 2003
• Study Completion: October 1, 2003
• Last Updated: February 28, 2012

Record last verified: 2012-02