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Type 2 DiabetesPhase 3NCT00376181

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

A Phase 3 study testing Pioglitazone and Azilsartan and Pioglitazone in people with Type 2 Diabetes, run by Takeda at 73 sites in 5 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Pioglitazone and Azilsartan and Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
96 participants
Where
73 sitesin 5 countries
Study dates
Jun 2006to May 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Clinical laboratory evaluations (including clinical chemistry, hematology, and urinalysis) within the reference range unless the results are deemed not clinically significant for inclusion into this study by the investigator.
  • 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.

Who cannot join

  • 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.
Show all 24Show fewer
  • 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.
  • Is hypersensitive to angiotensin II receptor blockers.
  • Is hypersensitive to thiazolidinediones.
  • Is 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:
  • any anti-diabetic agent (including thiazolidinediones and/or insulin) except for metformin or a combination of metformin and a sulfonylurea
  • niacin more than 200mg per day
  • tricyclic antidepressants or phenothiazines
  • Angiotensin II receptor blockers
  • Thiazolidinediones
  • Insulin

Trial locations and contacts

73 sites in 5 countries.

73 sites in 5 countries

United States59 sites

  • Study site

    Albany, New York

  • Study site

    Auburn, California

  • Study site

    Augusta, Georgia

  • Study site

    Bakersfield, California

  • Study site

    Bloomington, Indiana

  • Study site

    Bristol, Tennessee

  • Study site

    Buckingham, Pennsylvania

  • Study site

    Buena Park, California

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Chula Vista, California

  • Study site

    Dallas, Texas

  • Study site

    Deerfield Beach, Florida

  • Study site

    Dunwoody, Georgia

  • Study site

    El Paso, Texas

  • Study site

    Euless, Texas

  • Study site

    Evansville, Indiana

  • Study site

    Falls Church, Virginia

  • Study site

    Fort Worth, Texas

  • Study site

    Hialeah, Florida

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Huntington Park, California

  • Study site

    Huntsville, Alabama

  • Study site

    Jacksonville, Florida

  • Study site

    Jeannette, Pennsylvania

  • Study site

    Johnson City, New York

  • Study site

    Kissimmee, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Little Rock, Arkansas

  • Study site

    Livonia, Michigan

  • Study site

    Los Gatos, California

  • Study site

    Marianna, Florida

  • Study site

    Marion, Ohio

  • Study site

    McKinney, Texas

  • Study site

    Melbourne, Florida

  • Study site

    Miami, Florida

  • Study site

    Midland, Texas

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    New Tazewell, Tennessee

  • Study site

    North Richland Hills, Texas

  • Study site

    Norwalk, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Orangevale, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Prince Frederick, Maryland

  • Study site

    Sacramento, California

  • Study site

    Saint Clair Shores, Michigan

  • Study site

    Salisbury, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Simpsonville, South Carolina

  • Study site

    Staten Island, New York

  • Study site

    Stockton, California

  • Study site

    Tallassee, Alabama

  • Study site

    Trenton, New Jersey

  • Study site

    Virginia Beach, Virginia

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Haven, Florida

Other trials in United States

Mexico5 sites

  • Study site

    Guadalajara

  • Study site

    León, Guanajuato

  • Study site

    Mexico City

  • Study site

    Monterrey, Nuevo León

  • Study site

    Zapopan, Jalisco

Other trials in Mexico

Peru4 sites

  • Study site

    Arequipa

  • Study site

    Lambayeque

  • Study site

    Lima

  • Study site

    Trujillo

Other trials in Peru

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Santa Fe

Other trials in Argentina

Chile2 sites

  • Study site

    Santiago

  • Study site

    Temuco

Other trials in Chile

About this study

Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Determine the Efficacy, Safety, and Tolerability of AD-4833-536 in the Treatment of Subjects With Type 2 Diabetes

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.

Read the detailed description

Type 2 diabetes is a chronic disease. In the United States, an estimated 21 million people have diabetes, with type 2 diabetes occurring in 90% to 95% of cases. Hypertension (high blood pressure) affects approximately 50 million individuals in the United States. The association of diabetes and hypertension is increased in this population; hypertension is more common in persons with diabetes while individuals with hypertension are 2.5 times more likely to develop diabetes than those who have normal blood pressure. As a result, more than 70% of adults with diabetes have hypertension (defined as having blood pressure greater than or equal to 130/80 mm Hg or using prescription medication for hypertension).

Patients with type 2 diabetes and hypertension are at high risk of other illnesses and death. Diabetes and hypertension are associated with insulin resistance (normal amounts of insulin are no adequate to produce a normal insulin response from fat, muscle and liver cells). and hyperinsulinemia (excess levels of insulin in the blood), which are independent risk factors for cardiovascular (heart vessel) disease. Individuals with type 2 diabetes carry a 2 to 4- time greater risk of cardiovascular disease and stroke compared with the general population. Uncontrolled hypertension also is associated with an increased risk of cardiovascular disease and stroke.

Takeda Global Research and Development Center, Inc. is developing a fixed-dose combination product, AD-4833-536. AD-4833-536 is a combination of AD-4833 (pioglitazone) and TAK-536 (azilsartan). Pioglitazone is an oral antidiabetic agent that acts by reducing insulin resistance and approved for treatment of adult patients with type 2 diabetes mellitus. Azilsartan is a angiotensin II receptor blocker that modulates the renin-angiotensin-aldosterone system that regulates blood pressure.

Conditions
Type 2 Diabetes
Being tested
Pioglitazone and Azilsartan, Pioglitazone
Keywords
type 2 diabetes, hypertension, blood pressure, diastolic blood pressure
Medical subject headings
Diabetes Mellitus, Type 2, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pioglitazone and AzilsartanDrug

    Also called Actos, AD-4833, TAK-536

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

  • Pioglitazone and AzilsartanDrug

    Also called Actos, AD-4833, TAK-536

    Pioglitazone 45 mg and Azilsartan 40 mg combination tablets, orally, once daily for up to 24 weeks.

  • PioglitazoneDrug

    Also called Actos, AD-4833

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

Study groups in NCT00376181
Study groupRoleWhat they receive
Pioglitazone 45 mg/Azilsartan 20 mg QDExperimentalNot described
Receives: Drug: Pioglitazone and Azilsartan
Pioglitazone 45 mg/Azilsartan 40 mg QDExperimentalNot described
Receives: Drug: Pioglitazone and Azilsartan
Pioglitazone 45 mg QDActive comparatorNot described
Receives: Drug: Pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 24

Secondary outcomes (2)

  1. Change from Baseline in Diastolic Blood Pressure

    The change between Diastolic Blood Pressure measured at each week indicated including final visit and Diastolic Blood Pressure measured at baseline.

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

  2. Change from Baseline in Systolic Blood Pressure

    The change between Systolic Blood Pressure measured at each week indicated including final visit and Systolic Blood Pressure measured at baseline.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionMay 2007
  4. Study completionMay 2007

Why it stopped: Combination formulation concerns

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00376181
Sponsor's protocol ID
01-06-TL-OPI536-003
Other IDs
U1111-1114-1098
Status last verified
Jun 2010
First submitted
12 Sep 2006
Last updated
22 Jun 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pioglitazone and Azilsartan and Pioglitazone in people with Type 2 Diabetes, run by Takeda at 73 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in United States, Mexico, Peru, Argentina, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Combination formulation concerns). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Glycosylated Hemoglobin. (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00376181.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2010.

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