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Diabetes MellitusPhase 3NCT00331487

Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia

A Phase 3 study testing Pioglitazone and Rosiglitazone in people with Diabetes Mellitus, run by Takeda at 67 sites in United States.

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

Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with Type 2 Diabetes Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Diabetes Mellitus
What is being tested?
Pioglitazone and Rosiglitazone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
719 participants
Where
67 sitesUnited States
Study dates
Sep 2000to Mar 2004
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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetes mellitus according to the World Health Organization criteria and have diabetes-associated dyslipidemia (fasting triglycerides level between greater than or equal to 150 mg per dL and less than or equal to 600 mg per dL, and a fasting direct low-density lipoprotein cholesterol less than or equal to 130 mg per dL).
  • Fasting serum C-peptide greater than or equal to1 ng per
  • Glycosylated hemoglobin greater than or equal to 7% and less than or equal to 11% if naive to oral antihyperglycemic medications, or greater than or equal to 9.5% if previously treated with oral antihyperglycemic monotherapy

Who cannot join

  • Investigator site personnel and their immediate families. Immediate family defined as a spouse, parent, child or sibling, whether biological or legally adopted.
  • Treatment with a drug within 30 days of Visit 1 that had not received regulatory approval.
  • Treatment within 60 days of Visit 1 with any of the following:
  • insulin
  • systemic glucocorticoid therapy (excluding topical and inhaled preparations)
  • combination glycemic therapy (two or more oral anti-diabetes medications)
Show all 24Show fewer
  • any lipid-lowering agent (including nicotinic acid, fibrates, bile acid resin binders, statins, d thyroxine or neomycin)
  • any weight loss agent (prescription or over the counter)
  • Pregnant, breast feeding, or intending to become pregnant during the study.
  • Serum creatinine greater than or equal to 176.8 μmol per L or greater than or equal to 2 plus per dipstick.
  • Proteinuria at Visit 1.
  • Alanine transaminase or aspartate transaminase greater than or equal to 1.5 times the upper limit of normal at Visit 1 or had significant clinical signs or symptoms of liver disease.
  • History of signs or symptoms of liver disease, such as jaundice or alanine transaminase greater than or equal to 1.5 times the upper limit of normal, while treated with any thiazolidinedione
  • Hemoglobin less than 10.5 g per dL for females and less than11.5 g per dL for males at Visit 1.
  • Clinically or biochemically based on thyroid stimulating hormone at Visit 1 hypothyroid or hyperthyroid.
  • History of myocardial infarction, acute cardiovascular event, or heart surgery within 6 months of Visit 1.
  • Functional New York Heart Association Cardiac Class III or IV disease.
  • Receiving renal dialysis or has had received a renal transplant.
  • Undergoing therapy for a malignancy other than basal cell or squamous cell skin cancer.
  • Clinical signs or symptoms of drug or alcohol abuse.
  • History of HIV infection.
  • Allergy to any glitazone drug.
  • Medical history or the presence of any clinically significant or unstable medical condition that made the patient unlikely to complete the study.
  • Any condition or situations that precluded adherence and completion of the protocol or a precluding ability to voluntarily give informed consent.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

United States67 sites

  • Study site

    Anniston, Alabama, 36207

  • Study site

    Atlanta, Georgia, 30342

  • Study site

    Aurora, Colorado, 80010

  • Study site

    Avon, Connecticut, 06001

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Beaumont, Texas, 77701

  • Study site

    Birmingham, Alabama, 35234

  • Study site

    Charlotte, North Carolina, 28211

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Chicago, Illinois, 60610

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Concord, California, 94520

  • Study site

    Conroe, Texas, 77384

  • Study site

    Dallas, Texas, 75390

  • Study site

    Durham, North Carolina, 27713

  • Study site

    East Setauket, New York, 11733

  • Study site

    Endwell, New York, 13760

  • Study site

    Englewood, Colorado, 80110

  • Study site

    Fayetteville, Georgia, 30214

  • Study site

    Federal Way, Washington, 98003

  • Study site

    Franklin, Ohio, 45005

  • Study site

    Frederick, Maryland, 21702

  • Study site

    Fremont, California, 94538

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Hamden, Connecticut, 06518

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77024

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Knoxville, Tennessee, 37909

  • Study site

    Lake Jackson, Texas, 77566

  • Study site

    Longwood, Florida, 32750

  • Study site

    Los Angeles, California, 90095

  • Study site

    Mechanicsville, Virginia, 23111

  • Study site

    Memphis, Tennessee, 38119

  • Study site

    Miami, Florida, 33133

  • Study site

    Miami, Florida, 33136

  • Study site

    Milwaukee, Wisconsin, 53209

  • Study site

    Minneapolis, Minnesota, 55416

  • Study site

    Morehead City, North Carolina, 28557

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    New Orleans, Louisiana, 70127

  • Study site

    New York, New York, 10025

  • Study site

    Newport News, Virginia, 23606

  • Study site

    Ogden, Utah, 84403

  • Study site

    Omaha, Nebraska

  • Study site

    Palos Verdes Estates, California, 90274

  • Study site

    Philadelphia, Pennsylvania, 19124

  • Study site

    Portland, Oregon, 97201

  • Study site

    Pottstown, Pennsylvania, 19464

  • Study site

    Providence, Rhode Island, 02908

  • Study site

    Rochester, New York, 14607

  • Study site

    Salem, Oregon, 97302

  • Study site

    Salisbury, Massachusetts, 01952

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92120

  • Study site

    Santa Barbara, California, 93105

  • Study site

    Santa Rosa, California, 95405

  • Study site

    South Bend, Indiana, 46601

  • Study site

    South Yarmouth, Massachusetts, 02664

  • Study site

    Staten Island, New York, 10305

  • Study site

    Tucson, Arizona, 85710

  • Study site

    Tulsa, Oklahoma, 74136

  • Study site

    Virginia Beach, Virginia, 23455

  • Study site

    Waltham, Massachusetts, 02453

  • Study site

    Wenatchee, Washington, 98801

  • Study site

    Wilmington, North Carolina, 28412

Other trials in United States

About this study

Official title: Pioglitazone Versus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia

Efficacy comparison of Pioglitazone, once daily (QD), to Rosiglitazone in participants with Type 2 Diabetes

Read the detailed description

At least two metabolic defects contribute to the development of type 2 diabetes mellitus: relative insulin insufficiency and insulin resistance. The majority of patients with type 2 diabetes mellitus demonstrate some degree of insulin resistance. Even in the absence of hyperglycemia (high blood sugar), insulin resistance is associated with a cluster of metabolic abnormalities that increase the risk for cardiovascular disease, including dyslipidemia (unhealthy blood fat), increased expression of inflammatory markers, activation of pro-coagulants (pro-clotting), hemodynamic changes, and endothelial dysfunction.

The dyslipidemia associated with insulin resistance and type 2 diabetes mellitus is characterized by elevated triglyceride levels and decreased high-density lipoprotein (good) cholesterol levels. Although low-density lipoprotein (bad) cholesterol levels may not be significantly elevated in patients with type 2 diabetes mellitus, an increase in the proportion of small, dense low-density lipoprotein cholesterol particles of increased atherogenicity (increased formation of lipid deposits in the arteries) is observed. When compared with individuals without type 2 diabetes mellitus, the risk of cardiovascular disease is 2- to 4-fold greater in patients with type 2 diabetes mellitus, and the dyslipidemia of diabetes is an important contributor to the increased risk in this population.

By targeting the insulin resistance underlying type 2 diabetes mellitus, the thiazolidinedione class of oral antihyperglycemic medications possesses both a glucose-lowering effect and the potential to alter lipid/lipoprotein metabolism. Two thiazolidinediones are currently available for the treatment of type 2 diabetes mellitus: pioglitazone hydrochloride (ACTOS, Takeda Pharmaceuticals North America, Inc, Lincolnshire, IL) and rosiglitazone maleate (Avandia, GlaxoSmithKline, Research Triangle Park, NC).

The purpose of this study is to evaluate the triglyceride-lowering effects of pioglitazone to rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia who are not receiving any other glucose- or lipid-lowering therapies at the same time as the study medications.

Individuals who participate in this study will provide written informed consent and will be required to commit to a screening visit and approximately 7 additional visits at the study center. Study participation is anticipated to be about 39 weeks (or approximately 8 months). Multiple procedures will occur at each visit which may include fasting, blood collection, physical examinations and electrocardiograms. Participants will be required to follow a diabetic diet, self-monitor their blood glucose and maintain a study diary for the duration of the study.

Being tested
Pioglitazone, Rosiglitazone
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, Dyslipidemias

What participants receive

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

  • PioglitazoneDrug

    Also called Actos, AD4833

    Pioglitazone 30 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to pioglitazone 45 mg, capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks

  • RosiglitazoneDrug

    Rosiglitazone 4 mg capsules, orally, once daily and placebo-matching capsules, orally, once daily for up to 12 weeks; increasing to rosiglitazone 4 mg, capsules, orally, twice daily for up to 12 weeks

Study groups in NCT00331487
Study groupRoleWhat they receive
Pioglitazone QDExperimentalNot described
Receives: Drug: Pioglitazone
Rosiglitazone QDActive comparatorNot described
Receives: Drug: Rosiglitazone

What is being measured

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

  1. Change in fasting triglyceride level

    Measured: Final Visit

Secondary outcomes (20)

  1. Change in fasting low-density lipoprotein cholesterol.

    Measured: Final Visit

  2. Change in fasting high-density lipoprotein cholesterol.

    Measured: Final Visit

  3. Change in fasting total cholesterol.

    Measured: Final Visit

  4. Change in fasting free fatty acids.

    Measured: Final Visit

  5. Change in plasminogen activator inhibitor 1

    Measured: Final Visit

  6. Change in high-sensitivity C-reactive protein

    Measured: Final Visit

  7. Change in fasting C-peptide.

    Measured: Final Visit

  8. Homeostasis model assessment-insulin resistance mode.

    Measured: Final Visit

  9. Change in fasting insulin.

    Measured: Final Visit

  10. Homeostasis model assessment-beta cell function.

    Measured: Final Visit

  11. Change in glycosylated hemoglobin.

    Measured: Final Visit

  12. Change in fasting plasma glucose.

    Measured: Final Visit

  13. Low-density lipoprotein particle concentration.

    Measured: Final Visit

  14. Low-density lipoprotein particle size.

    Measured: Final Visit

  15. High-density lipoprotein particle size.

    Measured: Final Visit

  16. Very low-density lipoprotein particle size.

    Measured: Final Visit

  17. Apolipoprotein A-I.

    Measured: Final Visit

  18. Apolipoprotein B

    Measured: Final Visit

  19. Lipoprotein a

    Measured: Final Visit

  20. Apolipoprotein C-III.

    Measured: 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 posted31 May 2006 (estimated)
  2. Study startSep 2000
  3. Primary completionMar 2004
  4. Study completionMar 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
719 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00331487
Sponsor's protocol ID
H6E-US-GLAI
Other IDs
U1111-1115-9039
Status last verified
Feb 2012
First submitted
30 May 2006
Last updated
28 Feb 2012
Results posted
No
Data monitoring committee
No

Publications

  • Goldberg RB, Kendall DM, Deeg MA, Buse JB, Zagar AJ, Pinaire JA, Tan MH, Khan MA, Perez AT, Jacober SJ; GLAI Study Investigators. A comparison of lipid and glycemic effects of pioglitazone and rosiglitazone in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2005 Jul;28(7):1547-54. doi: 10.2337/diacare.28.7.1547.

    PubMed 15983299

  • Tilden DP, Mariz S, O'Bryan-Tear G, Bottomley J, Diamantopoulos A. A lifetime modelled economic evaluation comparing pioglitazone and rosiglitazone for the treatment of type 2 diabetes mellitus in the UK. Pharmacoeconomics. 2007;25(1):39-54. doi: 10.2165/00019053-200725010-00005.

    PubMed 17192117

  • Deeg MA, Buse JB, Goldberg RB, Kendall DM, Zagar AJ, Jacober SJ, Khan MA, Perez AT, Tan MH; GLAI Study Investigators. Pioglitazone and rosiglitazone have different effects on serum lipoprotein particle concentrations and sizes in patients with type 2 diabetes and dyslipidemia. Diabetes Care. 2007 Oct;30(10):2458-64. doi: 10.2337/dc06-1903. Epub 2007 Jun 26.

    PubMed 17595355

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pioglitazone and Rosiglitazone in people with Diabetes Mellitus, run by Takeda at 67 sites in United States.

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 3 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: 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 67 sites in United States. 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 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 in fasting triglyceride level (time frame: 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 NCT00331487, which also lists 3 linked publications.

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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