Efficacy and Safety Study of Pioglitazone Combined With Metformin on Metabolic Syndrome in Subjects With Type 2 Diabetes

NCT00772174 | Completed Phase 3

• 4 other identifiers: IT-PIO-1082006-000725-54PIOc/LAN07/TIFU1111-1115-9278
• Study Type: interventional
• Target: 418
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to determine the efficacy of pioglitazone taken with metformin on high-density lipoprotein cholesterol in subjects with Type 2 Diabetes.

Conditions

Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Increase in High-Density Lipoprotein cholesterol levels.

  Final Visit.

Secondary Outcomes (5)

• The change from Baseline in Metabolic Syndrome, as defined by the International Diabetes Federation (aggregate waist circumference, fasting plasma glucose, triglycerides and high-density lipoprotein cholesterol).

  Weeks: 8 and 24.

• The change from Baseline in Metabolic Syndrome, as defined by the International Diabetes Federation (blood pressure).

  At all Visits.

• The change from Baseline in Individual Metabolic Parameters (insulin sensitivity and beta-cell function, inflammatory cytokines, adipokines, endothelial functionality).

  Weeks: 8 and 24.

• Adverse Events.

  At all Visits.

• The change from Baseline in Laboratory Parameters (hematology, chemistry and urinalysis).

  Weeks: 8 and 24.

Study Arms (2)

Pioglitazone + Metformin

EXPERIMENTAL

Drug: Pioglitazone and Metformin

Metformin

ACTIVE COMPARATOR

Drug: Metformin

Interventions

Pioglitazone and Metformin DRUG

Pioglitazone 15 mg, tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone 15 mg, tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.

Also known as: ACTOS®, AD4833

Pioglitazone + Metformin

Metformin DRUG

Pioglitazone placebo-matching tablets, orally, two-times daily and metformin stable dose, orally, three-times daily for 4 weeks; then increased to pioglitazone placebo-matching tablets, orally, three-times daily and metformin stable dose, orally, three-times daily for up to 20 weeks.

Metformin

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Type 2 Diabetes Mellitus.
• Has glycosylated hemoglobin levels between 6.0% and 8.0%.
• Treatment with metformin (2,000 to 3,000 mg daily) for at least 3 months.
• Has reduced high-density lipoprotein cholesterol levels less than 40 mg/dl in males and less than 50 mg/dl in females, irrespective of treatment with statins.
• Has central obesity defined as a waist circumference greater than or equal to 94 cm for men and greater than or equal to 80 cm for females.
• 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.

You may not qualify if:

• Has a diagnosis of Type 1 Diabetes Mellitus.
• Required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
• other oral antidiabetic drugs than metformin or with insulin in the 3 months preceding study entry.
• Fibrates
• Rifampicin
• Has any disease with malabsorption.
• Has acute or chronic pancreatitis.
• Has familial polyposis coli.
• Has a medical history of myocardial infarction, transient ischemic attacks or stroke in the past 6 months.
• Has heart failure as defined by the New York Heart Association classification I-IV.
• Has significant liver impairment, with an alanine aminotransferase level greater than 2.5 the upper limit of normal range.
• Has significant renal impairment, with a serum creatinine level greater than 1.5 mg/dl for men and greater than 1.2 mg/dl for women.
• Has anemia of any etiology (defined as hemoglobin levels less than 10.5 g/dL) or any other hematologic disease.
• Has a diagnosis or suspicion of neoplastic disease.
• History of chronic alcohol or drug abuse.

Sponsors & Collaborators

• Takeda: lead

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

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

Interventions

Pioglitazone; Metformin

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; Biguanides; Guanidines; Amidines

Study Officials

• Medical Director

  Takeda

  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

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 15, 2008
• Study Start: January 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: July 5, 2010

Record last verified: 2010-07