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Diabetes MellitusPhase 4COMPLEMENTNCT00672919

Pioglitazone Study of Triglyceride Changes in Subjects With Type 2 Diabetes After Conversion From Rosiglitazone.

A Phase 4 study testing Pioglitazone in people with Diabetes Mellitus, run by Takeda at 53 sites in 2 countries.

Completed

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

Official record
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Trial summary

The purpose of this study is to measure the triglyceride changes in subjects with type 2 diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from rosiglitazone. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Pioglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
305 participants
Where
53 sitesin 2 countries
Study dates
Nov 2003to Aug 2004
Phase
Phase 4
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with type 2 diabetes mellitus
  • 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
  • Has been taking a stable dose of rosiglitazone for greater than 90 days prior to screening.
  • Has a triglyceride level greater than 200 mg per dL but less than 1000 mg per dL.
  • Has been taking a stable statin therapy for greater than 90 days prior to screening.
  • Has a glycosylated hemoglobin less than 10.5%.

Who cannot join

  • Type 1 diabetes mellitus.
  • Treated with Gemfibrozil within 90 days of screening.
  • Previous history of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug.
  • The subject has an alanine aminotransaminase level of greater than 2.5 times the upper limit of normal, active liver disease, or jaundice.
  • Male subjects who have serum creatinine greater than 2.0 mg per dL and female subjects with serum creatinine greater than1.8 mg per dL.
  • Unexplained microscopic hematuria greater than plus 1 confirmed by repeat testing.
Show all 15Show fewer
  • Male subjects who have hemoglobin less than 10.5 g per dL and female subjects who have hemoglobin less than 10.0 g per dL.
  • Significant cardiovascular disease including, but not limited to, New York Heart Association Functional (Cardiac) Classification III or IV
  • Currently is participating in another investigational study or has participated in an investigational study within the past 30 days.
  • Any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol.
  • Is required to take or continues taking any disallowed medication, prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
  • Glucocorticoids (eg. prednisone, cortisone, hydrocortisone, dexamethasone) with the exception of a topical glucocorticoid agent.
  • Gemfibrozil
  • Steroid-joint injections.
  • Thiazolidinediones with the exception of the study medication.

Trial locations and contacts

53 sites in 2 countries.

53 sites in 2 countries

United States51 sites

  • Study site

    Arlington, Texas

  • Study site

    Arvada, Colorado

  • Study site

    Aventura, Florida

  • Study site

    Bellflower, California

  • Study site

    Birmingham, Alabama

  • Study site

    Burlingame, California

  • Study site

    Centerville, Ohio

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chesterfield, Missouri

  • Study site

    Chicago Heights, Illinois

  • Study site

    Columbus, Georgia

  • Study site

    Dayton, Ohio

  • Study site

    Des Moines, Iowa

  • Study site

    Evansville, Indiana

  • Study site

    Fall River, Massachusetts

  • Study site

    Fresno, California

  • Study site

    Hollywood, Florida

  • Study site

    Houston, Texas

  • Study site

    Idaho Falls, Idaho

  • Study site

    Jacksonville, Florida

  • Study site

    La Jolla, California

  • Study site

    Lafayette, Louisiana

  • Study site

    Long Beach, California

  • Study site

    Man, West Virginia

  • Study site

    Meadville, Pennsylvania

  • Study site

    Medford, Oregon

  • Study site

    Miami, Florida

  • Study site

    Midland, Texas

  • Study site

    Morristown, Tennessee

  • Study site

    Murfreesboro, Tennessee

  • Study site

    Nashville, Tennessee

  • Study site

    North Miami Beach, Florida

  • Study site

    Norwalk, Connecticut

  • Study site

    Ogden, Utah

  • Study site

    Omaha, Nebraska

  • Study site

    Orange, Virginia

  • Study site

    Pasadena, California

  • Study site

    Pittsburgh, Pennsylvania

  • Study site

    Raleigh, North Carolina

  • Study site

    San Antonio, Texas

  • Study site

    Staten Island, New York

  • Study site

    Tallahassee, Florida

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

  • Study site

    Virginia Beach, Virginia

  • Study site

    Waltham, Massachusetts

  • Study site

    Warwick, Rhode Island

  • Study site

    Waterbury, Connecticut

  • Study site

    Wausau, Wisconsin

  • Study site

    West Palm Beach, Florida

  • Study site

    Winston-Salem, North Carolina

Other trials in United States

Puerto Rico2 sites

  • Study site

    Carolina

  • Study site

    Ponce

Other trials in Puerto Rico

About this study

Official title: A Single-Arm, Open-Label, Multicenter Study Evaluating the Triglyceride Changes in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia Following Treatment Conversion From Rosiglitazone to Pioglitazone HCl in Combination With Stable Statin Therapy

The purpose of this study is to measure the triglyceride changes in subjects with type 2 diabetes mellitus taking pioglitazone, once daily (QD), following treatment conversion from rosiglitazone.

Read the detailed description

Diabetes mellitus 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, physical habits 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 (liver) and peripheral-tissue cells to circulating insulin (ie, insulin resistance) to a progressive inability of the body to produce adequate insulin to overcome insulin resistance (ie, 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 to 95% of cases.

Therapeutic agents have been developed to address each of the major functional metabolic defects associated with type 2 diabetes. Recently introduced drugs for diabetes therapy are the thiazolidinedione class. Thiazolidinediones increase glucose utilization, decrease gluconeogenesis and increase glucose disposal through an incompletely understood mechanism but one associated with binding of the drug to receptors known as peroxisomal proliferator-activated receptors.

Thiazolidinediones are peroxisomal proliferator-activated receptor agonists reducing insulin resistance in muscle cells, adipose (fat) tissue, and hepatic cells (inhibiting hepatic gluconeogenesis) with no direct impact on insulin secretion. Thus peroxisomal proliferator-activated receptor agonists improve glycemic control and result in reduced levels of circulating insulin. Peroxisomal proliferator-activated receptors are found in various tissues important for insulin action, with the greatest concentration of these receptors is in adipose tissue.

Pioglitazone is a peroxisomal proliferator-activated receptor agonist developed by Takeda Chemical Industries, Ltd. (Osaka, Japan).

Participation in this study is anticipated to be approximately 20 weeks.

Being tested
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.

  • PioglitazoneDrug

    Also called ACTOS®, AD-4833

    Pioglitazone 30 mg to 45 mg, tablets, orally, once daily in combination with stable statin therapy for up to 17 weeks.

Study groups in NCT00672919
Study groupRoleWhat they receive
Pioglitazone QDExperimental(and stable statin therapy)
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 Triglyceride Levels

    Measured: Weeks 8 and 17 or Final Visit

Secondary outcomes (8)

  1. Change from Baseline in Total Cholesterol

    Measured: Weeks 8 and 17 or Final Visit

  2. Change from Baseline in direct Low Density Lipoprotein cholesterol

    Measured: Weeks 8 and 17 or Final Visit

  3. Change from Baseline in High Density Lipoprotein cholesterol

    Measured: Weeks 8 and 17 or Final Visit

  4. Change from Baseline in apolipoprotein B (apoB)

    Measured: Weeks 8 and 17 or Final Visit

  5. Change from Baseline in apolipoprotein A1 (apoA1)

    Measured: Weeks 8 and 17 or Final Visit

  6. Change from Baseline in Free Fatty Acids

    Measured: Weeks 8 and 17 or Final Visit

  7. Change from Baseline in Lipid Fractionation

    Measured: Weeks 8 and 17 or Final Visit

  8. Change from Baseline in C-reactive Protein

    Measured: Weeks 8 and 17 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 posted6 May 2008 (estimated)
  2. Study startNov 2003
  3. Primary completionAug 2004
  4. Study completionAug 2004

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672919
Sponsor's protocol ID
01-03-TL-OPI-523
Other IDs
U1111-1115-8914
Acronym
COMPLEMENT
Status last verified
Feb 2012
First submitted
2 May 2008
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Berhanu P, Kipnes MS, Khan MA, Perez AT, Kupfer SF, Spanheimer RC, Demissie S, Fleck PR. Effects of pioglitazone on lipid and lipoprotein profiles in patients with type 2 diabetes and dyslipidaemia after treatment conversion from rosiglitazone while continuing stable statin therapy. Diab Vasc Dis Res. 2006 May;3(1):39-44. doi: 10.3132/dvdr.2006.005.

    PubMed 16784180

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pioglitazone in people with Diabetes Mellitus, run by Takeda at 53 sites in 2 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 15 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 53 sites in United States, Puerto Rico. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Triglyceride Levels (time frame: Weeks 8 and 17 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 NCT00672919, which also lists 1 linked publication.

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.

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