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Diabetes MellitusPhase 2NCT00762736

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

A Phase 2 study testing Pioglitazone and azilsartan and Pioglitazone in people with Diabetes Mellitus, run by Takeda at 78 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus
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
704 participants
Where
78 sitesin 5 countries
Study dates
Jul 2004to Oct 2005
Phase
Phase 2
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

  • 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 clinical laboratory evaluations (including clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory unless the results were deemed not clinically significant for inclusion into this study by the investigator or sponsor.
  • Had been on stable diet and exercise program and oral anti-glycemic therapy including sulfonylurea or metformin for 8 weeks prior to Screening.

Who cannot join

  • 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
Show all 28Show fewer
  • 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.
  • Had clinically significant cardiac conduction defects (eg, second or third degree atrioventricular block, left bundle branch block, sick sinus syndrome, atrial fibrillation or flutter).
  • Had secondary hypertension of any etiology (eg, renovascular disease, pheochromocytoma, Cushing's syndrome).
  • Had a history of collagen vascular disorder (eg, systemic lupus erythematosus, scleroderma) within the last 5 years.
  • Had a body mass index greater than 39 kg/m2.
  • Had significant, moderate-to-severe renal dysfunction (creatinine greater than 2.4 mg/dL). If receiving metformin, a creatinine greater than 1.5 mg/dL for male subjects or greater than 1.4 mg/dL for female subjects led to exclusion.
  • Had a history of drug abuse or a history of alcohol abuse within the past 2 years.
  • Had a previous history of cancer, other than basal cell carcinoma, that had not been in remission for at least 5 years prior to the first dose of study drug.
  • Had type 2 diabetes with clinically important retinopathy or peripheral or autonomic neuropathy.
  • Had an alanine aminotransferase or aspartate aminotransferase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  • Was participating in another investigational study or had participated in an investigational study within 30 days prior to randomization.
  • Had any other serious disease or condition at Screening (or randomization) that might have compromised subject safety, affected life expectancy, or made it difficult to successfully manage and follow the subject according to the protocol.
  • Was hypersensitive to angiotensin II receptor blockers.
  • Was hypersensitive to thiazolidinediones.

Trial locations and contacts

78 sites in 5 countries.

78 sites in 5 countries

United States64 sites

  • Study site

    Albany, New York

  • Study site

    Allentown, Pennsylvania

  • Study site

    Altoona, Pennsylvania

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Augusta, Georgia

  • Study site

    Berlin, New Jersey

  • Study site

    Birmingham, Alabama

  • Study site

    Blackwood, New Jersey

  • Study site

    Burbank, California

  • Study site

    Cadillac, Michigan

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Clinton, Oklahoma

  • Study site

    Coral Gables, Florida

  • Study site

    Dallas, Texas

  • Study site

    DeLand, Florida

  • Study site

    Detroit, Michigan

  • Study site

    Dyersburg, Indiana

  • Study site

    Escondido, California

  • Study site

    Fort Worth, Texas

  • Study site

    Greer, South Carolina

  • Study site

    Hollywood, Florida

  • Study site

    Honolulu, Hawaii

  • Study site

    Huntsville, Alabama

  • Study site

    Irvine, California

  • Study site

    Kansas City, Missouri

  • Study site

    Kingston, New York

  • Study site

    La Jolla, California

  • Study site

    Las Vegas, Nevada

  • Study site

    Lihue, Hawaii

  • Study site

    Livonia, Michigan

  • Study site

    Marion, Ohio

  • Study site

    Miami, Florida

  • Study site

    Midland, Texas

  • Study site

    National City, California

  • Study site

    New Orleans, Louisiana

  • Study site

    New Port Richey, Florida

  • Study site

    North Las Vegas, Nevada

  • Study site

    North Richard Hills, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Opa-locka, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Pembroke Pines, Florida

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Renton, Washington

  • Study site

    Riverside, California

  • Study site

    Sacramento, California

  • Study site

    Salisbury, Massachusetts

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Sarasota, Florida

  • Study site

    Scotland, Pennsylvania

  • Study site

    Shreveport, Louisiana

  • Study site

    Sierra Vista, Arizona

  • Study site

    Spring Valley, California

  • Study site

    St Louis, Missouri

  • Study site

    Sun City, Arizona

  • Study site

    Trenton, New Jersey

  • Study site

    Tucson, Arizona

  • Study site

    Vero Beach, Florida

  • Study site

    Warner Robins, Georgia

  • Study site

    Wichita, Kansas

  • Study site

    Woonsocket, Rhode Island

Other trials in United States

Mexico6 sites

  • Study site

    Aguascalientes

  • Study site

    Cuernavaca

  • Study site

    Durango

  • Study site

    Guadalajara

  • Study site

    Mexico City

  • Study site

    Puebla City

Other trials in Mexico

Argentina5 sites

  • Study site

    Buenos Aires

  • Study site

    Córdoba

  • Study site

    Rosario-Santa Fe

  • Study site

    Santa Fe

  • Study site

    Ushuaia - Tierre Del Fuego

Other trials in Argentina

Peru2 sites

  • Study site

    Ica

  • Study site

    Lima

Other trials in Peru

Chile1 site

  • Study site

    Santiago

Other trials in Chile

About this study

Official title: A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety, and Tolerability of Pioglitazone HCl (ACTOS™) in Combination With TAK-536 in Subjects With Type II Diabetes

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.

Read the detailed description

Diabetes is a chronic disease with multiple metabolic defects that result in hyperglycemia arising from inadequate insulin activity. Type 2 diabetes has a genetic predisposition, but lifestyle, body constitution and age play important roles in determining its time of onset and severity. Type 2 diabetes is usually the result of a progression from reduced sensitivity of hepatic and peripheral-tissue cells to circulating insulin (i.e., insulin resistance) to a progressive inability of the body to produce adequate insulin to overcome insulin resistance (i.e., insulin deficiency due to beta cell insufficiency) resulting in impaired glucose tolerance and ultimately overt diabetes. In the United States, an estimated 15.7 million people have diabetes, with type 2 diabetes occurring in approximately 90-95% of cases.

Therapeutic agents have been developed to address each of the major functional metabolic defects associated with type 2 diabetes: decreased beta-cell function, elevated hepatic glucose output, and insulin resistance. The oral therapeutic agents used in the treatment of type 2 diabetes can be separated into the following four categories based on their mechanisms of action: insulin secretagogues, inhibitors of hepatic glucose output, inhibitors of complex carbohydrate breakdown in the intestine and insulin sensitizers.

Thiazolidinediones reduce insulin resistance by enhancing insulin sensitivity in muscle cells, adipose tissue, and hepatic cells (inhibiting hepatic gluconeogenesis) with no direct impact on insulin secretion. Thus thiazolidinediones improve glycemic control and result in reduced levels of circulating insulin. Peroxisome proliferator-activated receptors are found in tissues important for insulin action, such as adipose tissue, skeletal muscle, and the liver. The greatest concentration of peroxisome proliferator-activated receptors -gamma receptors is in adipose tissue. Pioglitazone HCl (ACTOS®) is a thiazolidinedione developed by Takeda Chemical Industries, Ltd.

Research suggests that Angiotensin II receptor blockers are involved in endothelial and cardiovascular function, and in insulin sensitization and obesity. TAK-536 (azilsartan) is an angiotensin II receptor antagonist with affinity for and selective antagonistic activity at the angiotensin II type 1 receptor.

This study was designed to evaluate the efficacy, safety, and tolerability of pioglitazone in combination with azilsartan in subjects with type 2 diabetes.

Study participation is anticipated to be approximately 6 months.

Being tested
Pioglitazone and azilsartan, Pioglitazone
Keywords
Glucose Metabolism Disorder, Dysmetabolic Syndrome, Type II Diabetes, Diabetes Mellitus, Lipoatrophic, Dyslipidemia, Drug Therapy
Medical subject headings
Diabetes Mellitus, Glucose Metabolism Disorders, Diabetes Mellitus, Type 2, Diabetes Mellitus, Lipoatrophic, Dyslipidemias

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®, AD4833, TAK-536

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

  • Pioglitazone and azilsartanDrug

    Also called ACTOS®, AD4833, TAK-536

    Pioglitazone 15 mg, tablets, orally, once daily and azilsartan 40 mg, tablets, orally, once daily for up to 24 weeks.

  • PioglitazoneDrug

    Also called ACTOS®, AD4833

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

  • Pioglitazone and azilsartanDrug

    Also called ACTOS®, AD4833, TAK-536

    Pioglitazone 45 mg, tablets, orally, once daily and azilsartan 5 mg, tablets, orally, once daily for up to 24 weeks.

  • Pioglitazone and azilsartanDrug

    Also called ACTOS®, AD4833, TAK-536

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

  • PioglitazoneDrug

    Also called ACTOS®, AD4833

    Pioglitazone 45 mg, tablets, orally, once daily and azilsartan placebo-matching tablets, orally, once daily for up to 24 weeks.

Study groups in NCT00762736
Study groupRoleWhat they receive
Pioglitazone 15 mg QD + Azilsartan 5 mg QDExperimentalNot described
Receives: Drug: Pioglitazone and azilsartan
Pioglitazone 15 mg QD + Azilsartan 40 mg QDExperimentalNot described
Receives: Drug: Pioglitazone and azilsartan
Pioglitazone 15 mg QDActive comparatorNot described
Receives: Drug: Pioglitazone
Pioglitazone 45 mg QD + Azilsartan 5 mg QDExperimentalNot described
Receives: Drug: Pioglitazone and azilsartan
Pioglitazone 45 mg QD + 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.

    Measured: Week 24 or Final Visit

Secondary outcomes (12)

  1. Change from Baseline in glycosylated hemoglobin.

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

  2. Change from Baseline in fasting plasma glucose.

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

  3. Change from Baseline in total cholesterol.

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

  4. Change from Baseline in high-density lipoprotein.

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

  5. Change from Baseline in low-density lipoprotein.

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

  6. Change from Baseline in triglycerides.

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

  7. Change from Baseline in body weight.

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

  8. Change from Baseline in systolic and diastolic blood pressure.

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

  9. Change from Baseline in incidence of edema (peripheral).

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

  10. Change from Baseline in microalbuminuria excretion.

    Measured: Week 24 or Final Visit

  11. Change from Baseline in high-sensitivity C-reactive protein.

    Measured: Weeks 12 and 24 or Final Visit

  12. Change from Baseline in matrix metalloproteinase-9.

    Measured: Weeks 12 and 24 or Final Visit

Timeline

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

  1. First posted30 Sep 2008 (estimated)
  2. Study startJul 2004
  3. Primary completionOct 2005
  4. Study completionOct 2005

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
704 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00762736
Sponsor's protocol ID
01-04-TL-OPI-525
Other IDs
U1111-1115-8992
Status last verified
Feb 2012
First submitted
26 Sep 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pioglitazone and azilsartan and Pioglitazone in people with Diabetes Mellitus, run by Takeda at 78 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 5 inclusion and 28 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: finished, as of the sponsor's last update on 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Mexico, Argentina, Peru, 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: Week 24 or Final Visit). 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 NCT00762736.

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 28 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.

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