Efficacy and Safety of Pioglitazone and Azilsartan in Treating Subjects With Type 2 Diabetes Mellitus

NCT00762736 | Completed Phase 2

• 2 other identifiers: 01-04-TL-OPI-525U1111-1115-8992
• Study Type: interventional
• Target: 704
• Locations: 5 countries
• Sites: 78

Brief Summary

The purpose of this study is to determine the efficacy of pioglitazone, once daily (QD), combined with azilsartan in the treatment of subjects with Type 2 Diabetes Mellitus.

Conditions

Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in glycosylated hemoglobin.

  Week 24 or Final Visit

Secondary Outcomes (12)

• Change from Baseline in glycosylated hemoglobin.

  Weeks 12, 16, 20, and 24 or Final Visit

• Change from Baseline in fasting plasma glucose.

  Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit

• Change from Baseline in total cholesterol.

  Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit

• Change from Baseline in high-density lipoprotein.

  Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit

• Change from Baseline in low-density lipoprotein.

  Weeks 2, 4, 6, 8. 12, 16, 20, and 24 or Final Visit

Study Arms (6)

Pioglitazone 15 mg QD + Azilsartan 5 mg QD

EXPERIMENTAL

Drug: Pioglitazone and azilsartan

Pioglitazone 15 mg QD + Azilsartan 40 mg QD

EXPERIMENTAL

Drug: Pioglitazone and azilsartan

Pioglitazone 15 mg QD

ACTIVE COMPARATOR

Drug: Pioglitazone

Pioglitazone 45 mg QD + Azilsartan 5 mg QD

EXPERIMENTAL

Drug: Pioglitazone and azilsartan

Pioglitazone 45 mg QD + Azilsartan 40 mg QD

EXPERIMENTAL

Drug: Pioglitazone and azilsartan

Pioglitazone 45 mg QD

ACTIVE COMPARATOR

Drug: Pioglitazone

Interventions

Pioglitazone and azilsartan DRUG

Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks.

Also known as: ACTOS®, AD4833, TAK-536

Pioglitazone 15 mg QD + Azilsartan 5 mg QD

Pioglitazone DRUG

Pioglitazone 15 mg, tablets, orally, once daily and azilsartan placebo-matching tablets, orally, once daily for up to 24 weeks.

Also known as: ACTOS®, AD4833

Pioglitazone 15 mg QD

Eligibility Criteria

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

You may qualify if:

• Had type 2 diabetes, with a hemoglobin value of greater than or equal to 8.0% or less than 10.0% at Screening.
• Females of childbearing potential who were sexually active agreed to use adequate contraception, and were neither pregnant nor lactating from Screening throughout the duration of the study.
• Received antihypertensive therapy and must have been on a stable dose for a minimum of 8 weeks prior to Screening.
• Had been on stable diet and exercise program and oral anti-glycemic therapy including sulfonylurea or metformin for 8 weeks prior to Screening.

You may not qualify if:

• Had a hemoglobin value less than 8.0% or greater than 10.0% at Screening.
• Was taking an angiotensin II receptor blocker.
• Had uncontrolled hypertension defined as systolic blood pressure greater than 160 mm Hg and diastolic blood pressure greater than 100 mm Hg. - Had a systolic blood pressure less than or equal to 110 mm Hg and/or diastolic blood pressure less than or equal to 60 mm Hg.
• Was taking or was expected to take the following medications:
• antidiabetic agents (other than sulfonylurea or metformin)
• tricyclic antidepressants
• monoamine oxidase inhibitors
• phenothiazines
• diet medications
• amphetamines or their derivatives
• lithium
• common cold medications with chronic use
• nonsteroidal anti-inflammatory drugs with chronic use (including aspirin greater than 325 mg/day or cyclooxygenase 2 inhibitors).
• Had unstable angina or heart failure of any etiology with functional class New York Heart Association III or IV.
• Had a history of myocardial infarction.

Sponsors & Collaborators

• Takeda: lead

Study Sites (78)

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Birmingham, Alabama, United States

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Huntsville, Alabama, United States

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Sierra Vista, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Burbank, California, United States

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Escondido, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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National City, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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Spring Valley, California, United States

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Coral Gables, Florida, United States

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DeLand, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Opa-locka, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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Vero Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Warner Robins, Georgia, United States

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Honolulu, Hawaii, United States

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Lihue, Hawaii, United States

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Chicago, Illinois, United States

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Dyersburg, Indiana, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Salisbury, Massachusetts, United States

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Cadillac, Michigan, United States

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Detroit, Michigan, United States

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Livonia, Michigan, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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North Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Blackwood, New Jersey, United States

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Trenton, New Jersey, United States

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Albany, New York, United States

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Kingston, New York, United States

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Charlotte, North Carolina, United States

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Marion, Ohio, United States

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Clinton, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Allentown, Pennsylvania, United States

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Altoona, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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Woonsocket, Rhode Island, United States

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Greer, South Carolina, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Midland, Texas, United States

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North Richard Hills, Texas, United States

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San Antonio, Texas, United States

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Renton, Washington, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Rosario-Santa Fe, Argentina

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Santa Fe, Argentina

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Ushuaia - Tierre Del Fuego, Argentina

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Santiago, Chile

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Aguascalientes, Mexico

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Cuernavaca, Mexico

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Durango, Mexico

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Guadalajara, Mexico

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Mexico City, Mexico

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Puebla City, Mexico

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Ica, Peru

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Lima, Peru

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Related Links

• Actos Package Insert

MeSH Terms

Conditions

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

Interventions

Pioglitazone; azilsartan

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

Study Officials

• VP Clinical Science Strategy

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: September 26, 2008
• First Posted: September 30, 2008
• Study Start: July 1, 2004
• Primary Completion: October 1, 2005
• Study Completion: October 1, 2005
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (64); PE (2); CL (1); AR (5); ME (6)