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

NCT00672919 | Completed Phase 4

• 2 other identifiers: 01-03-TL-OPI-523U1111-1115-8914
• Study Type: interventional
• Target: 305
• Locations: 2 countries
• Sites: 53

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.

Conditions

Diabetes Mellitus

Keywords

Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Triglyceride Levels

  Weeks 8 and 17 or Final Visit

Secondary Outcomes (8)

• Change from Baseline in Total Cholesterol

  Weeks 8 and 17 or Final Visit

• Change from Baseline in direct Low Density Lipoprotein cholesterol

  Weeks 8 and 17 or Final Visit

• Change from Baseline in High Density Lipoprotein cholesterol

  Weeks 8 and 17 or Final Visit

• Change from Baseline in apolipoprotein B (apoB)

  Weeks 8 and 17 or Final Visit

• Change from Baseline in apolipoprotein A1 (apoA1)

  Weeks 8 and 17 or Final Visit

Study Arms (1)

Pioglitazone QD

EXPERIMENTAL

(and stable statin therapy)

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

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

Also known as: ACTOS®, AD-4833

Pioglitazone QD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (53)

Unknown Facility

Birmingham, Alabama, United States

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Tucson, Arizona, United States

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Bellflower, California, United States

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Burlingame, California, United States

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Fresno, California, United States

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La Jolla, California, United States

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Long Beach, California, United States

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Pasadena, California, United States

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Arvada, Colorado, United States

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Norwalk, Connecticut, United States

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Waterbury, Connecticut, United States

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Aventura, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Tallahassee, Florida, United States

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West Palm Beach, Florida, United States

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Columbus, Georgia, United States

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Idaho Falls, Idaho, United States

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Chicago Heights, Illinois, United States

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Evansville, Indiana, United States

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Des Moines, Iowa, United States

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Lafayette, Louisiana, United States

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Fall River, Massachusetts, United States

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Waltham, Massachusetts, United States

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Tupelo, Mississippi, United States

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Chesterfield, Missouri, United States

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Omaha, Nebraska, United States

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Staten Island, New York, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Centerville, Ohio, United States

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Dayton, Ohio, United States

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Medford, Oregon, United States

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Meadville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Morristown, Tennessee, United States

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Murfreesboro, Tennessee, United States

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Nashville, Tennessee, United States

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Arlington, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Orange, Virginia, United States

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Virginia Beach, Virginia, United States

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Man, West Virginia, United States

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Wausau, Wisconsin, United States

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Carolina, Puerto Rico

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Ponce, Puerto Rico

Location

Related Publications (1)

• 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.

  PMID: 16784180 BACKGROUND

Related Links

• ACTOS® Package Insert

MeSH Terms

Conditions

Diabetes Mellitus; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus, Lipoatrophic; Dyslipidemias

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• VP Clinical Science Strategy

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2008
• First Posted: May 6, 2008
• Study Start: November 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: February 28, 2012

Record last verified: 2012-02

Locations

US (51); PR (2)