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

NCT ID: NCT00672919

Last Updated: 2012-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 305 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-11-30
• Study Completion Date: 2004-08-31

Brief 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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pioglitazone QD

(and stable statin therapy)

Group Type: EXPERIMENTAL

Pioglitazone

Intervention Type: DRUG

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

Interventions

Pioglitazone

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

Intervention Type: DRUG

Other Intervention Names

ACTOS®; AD-4833

Eligibility Criteria

Inclusion Criteria

• 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%.

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

VP Clinical Science Strategy

Role: STUDY_DIRECTOR

Takeda

Locations

Birmingham, Alabama, United States

Tucson, Arizona, United States

Bellflower, California, United States

Burlingame, California, United States

Fresno, California, United States

La Jolla, California, United States

Long Beach, California, United States

Pasadena, California, United States

Arvada, Colorado, United States

Norwalk, Connecticut, United States

Waterbury, Connecticut, United States

Aventura, Florida, United States

Hollywood, Florida, United States

Jacksonville, Florida, United States

Miami, Florida, United States

North Miami Beach, Florida, United States

Tallahassee, Florida, United States

West Palm Beach, Florida, United States

Columbus, Georgia, United States

Idaho Falls, Idaho, United States

Chicago Heights, Illinois, United States

Evansville, Indiana, United States

Des Moines, Iowa, United States

Lafayette, Louisiana, United States

Fall River, Massachusetts, United States

Waltham, Massachusetts, United States

Tupelo, Mississippi, United States

Chesterfield, Missouri, United States

Omaha, Nebraska, United States

Staten Island, New York, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Centerville, Ohio, United States

Dayton, Ohio, United States

Medford, Oregon, United States

Meadville, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Warwick, Rhode Island, United States

Chattanooga, Tennessee, United States

Morristown, Tennessee, United States

Murfreesboro, Tennessee, United States

Nashville, Tennessee, United States

Arlington, Texas, United States

Houston, Texas, United States

Midland, Texas, United States

San Antonio, Texas, United States

Ogden, Utah, United States

Orange, Virginia, United States

Virginia Beach, Virginia, United States

Man, West Virginia, United States

Wausau, Wisconsin, United States

Carolina, , Puerto Rico

Ponce, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: BACKGROUND

PMID: 16784180 (View on PubMed)

Related Links

http://general.takedapharm.com/content/file/pi.pdf?applicationcode=ab2d7112-8eb3-465a-8fda-35018a9eafb0&fileTypeCode=ACTOSPI

ACTOS® Package Insert

Other Identifiers

U1111-1115-8914

Identifier Type: REGISTRY

Identifier Source: secondary_id

01-03-TL-OPI-523

Identifier Type: -

Identifier Source: org_study_id