Efficacy, Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes Mellitus

NCT00376181 | Terminated Phase 3

• 2 other identifiers: 01-06-TL-OPI536-003U1111-1114-1098
• Study Type: interventional
• Target: 96
• Locations: 5 countries
• Sites: 73

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of pioglitazone-azilsartan, once daily (QD), in subjects with type 2 diabetes mellitus with poor glycemic control.

Conditions

Type 2 Diabetes

Keywords

type 2 diabetes; hypertension; blood pressure; diastolic blood pressure

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Glycosylated Hemoglobin.

  The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 24 or including final visit, and Glycosylated Hemoglobin collected at baseline.

  Baseline and Week 24

Secondary Outcomes (2)

• Change from Baseline in Diastolic Blood Pressure

  Baseline and Weeks 4, 8, 12, 16, 20, and 24.

• Change from Baseline in Systolic Blood Pressure

  Baseline and Weeks 4, 8, 12, 16, 20, and 24

Study Arms (3)

Pioglitazone 45 mg/Azilsartan 20 mg QD

EXPERIMENTAL

Drug: Pioglitazone and Azilsartan

Pioglitazone 45 mg/Azilsartan 40 mg QD

EXPERIMENTAL

Drug: Pioglitazone and Azilsartan

Pioglitazone 45 mg QD

ACTIVE COMPARATOR

Drug: Pioglitazone

Interventions

Pioglitazone and Azilsartan DRUG

Pioglitazone 45 mg and Azilsartan 20 mg combination tablets, orally, once daily for up to 24 weeks.

Also known as: Actos, AD-4833, TAK-536

Pioglitazone 45 mg/Azilsartan 20 mg QD

Pioglitazone DRUG

Pioglitazone 45 mg, tablets, orally, once daily for up to 24 weeks.

Also known as: Actos, AD-4833

Pioglitazone 45 mg QD

Eligibility Criteria

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

You may qualify if:

• Type 2 diabetes with glycosylated hemoglobin of greater than or equal to 9.0 to less than or equal to 11.0% at Screening.
• Documented hypertension.
• On a stable diet and exercise program in addition to metformin alone or combination of metformin and a sulfonylurea for a minimum of 8 weeks prior to screening.
• If receiving antihypertensive therapy, must be on no more than 3 agents and be on a stable regimen.
• 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:

• Type 1 diabetes mellitus.
• Diastolic blood pressure greater than 104 mm Hg at randomization visit.
• Currently taking an angiotensin II-receptor blocker.
• Unstable angina or heart failure of any etiology with New York Heart Association functional class III or IV.
• History of myocardial infarction, cerebrovascular accident (stroke), percutaneous coronary intervention, coronary artery bypass graft or transient ischemic attack within the previous six months.
• Clinically significant cardiac conduction defects.
• Secondary hypertension of any etiology.
• Body mass index greater than 45 kg/m2
• Has significant renal dysfunction.
• History of drug abuse or a history of alcohol abuse within the past 2 years.
• Previous history of cancer, other than basal cell carcinoma or stage 1 squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to the first dose of study drug.
• Alanine transaminase or aspartate transaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
• Serum potassium greater than the upper limit of normal.
• Currently participating in another investigational study or has participated in an investigational study within 30 days prior to Randomization.
• Any other serious disease or condition that would compromise subject safety, might affect life expectancy, or make it difficult to successfully manage and follow the subject according to the protocol.

Sponsors & Collaborators

• Takeda: lead

Study Sites (73)

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Huntsville, Alabama, United States

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Tallassee, Alabama, United States

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Little Rock, Arkansas, United States

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Auburn, California, United States

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Bakersfield, California, United States

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Buena Park, California, United States

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Chula Vista, California, United States

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Huntington Park, California, United States

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Los Gatos, California, United States

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Norwalk, California, United States

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Orangevale, California, United States

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Sacramento, California, United States

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Stockton, California, United States

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Deerfield Beach, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Marianna, Florida, United States

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Melbourne, Florida, United States

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Miami, Florida, United States

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Pembroke Pines, Florida, United States

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Winter Haven, Florida, United States

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Augusta, Georgia, United States

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Dunwoody, Georgia, United States

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Chicago, Illinois, United States

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Bloomington, Indiana, United States

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Evansville, Indiana, United States

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Shawnee Mission, Kansas, United States

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Prince Frederick, Maryland, United States

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Livonia, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Las Vegas, Nevada, United States

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Trenton, New Jersey, United States

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Albany, New York, United States

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Johnson City, New York, United States

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Staten Island, New York, United States

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Charlotte, North Carolina, United States

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Salisbury, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Marion, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Buckingham, Pennsylvania, United States

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Jeannette, Pennsylvania, United States

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Mt. Pleasant, South Carolina, United States

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Simpsonville, South Carolina, United States

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Bristol, Tennessee, United States

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New Tazewell, Tennessee, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Euless, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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McKinney, Texas, United States

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Midland, Texas, United States

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North Richland Hills, Texas, United States

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San Antonio, Texas, United States

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Falls Church, Virginia, United States

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Virginia Beach, Virginia, United States

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Buenos Aires, Argentina

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Córdoba, Argentina

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Santa Fe, Argentina

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Santiago, Chile

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Temuco, Chile

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León, Guanajuato, Mexico

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Zapopan, Jalisco, Mexico

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Monterrey, Nuevo León, Mexico

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Guadalajara, Mexico

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Mexico City, Mexico

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Arequipa, Peru

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Lambayeque, Peru

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Lima, Peru

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Trujillo, Peru

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Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Pioglitazone; azilsartan

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

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 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: September 12, 2006
• First Posted: September 14, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

ME (5); AR (3); PE (4); CL (2); US (59)