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

Sponsor:	Takeda Global Research & Development Center, Inc.
Information provided by:	Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00672919

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: Pioglitazone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Statins

Drug Information available for: Pioglitazone Pioglitazone hydrochloride Rosiglitazone Rosiglitazone Maleate

U.S. FDA Resources

Further study details as provided by Takeda Global Research & Development Center, Inc.:

Primary Outcome Measures:

Change from Baseline in Triglyceride Levels [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in Total Cholesterol [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in direct Low Density Lipoprotein cholesterol [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in High Density Lipoprotein cholesterol [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in apolipoprotein B (apoB) [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in apolipoprotein A1 (apoA1) [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in Free Fatty Acids [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in Lipid Fractionation [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]
Change from Baseline in C-reactive Protein [ Time Frame: Weeks 8 and 17 or Final Visit ] [ Designated as safety issue: No ]

Enrollment:	305
Study Start Date:	November 2003
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pioglitazone QD (and stable statin therapy)	Drug: Pioglitazone Pioglitazone 30 mg to 45 mg, tablets, orally, once daily in combination with stable statin therapy for up to 17 weeks. Other Names: ACTOS® AD-4833

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672919

Show 53 Study Locations

Sponsors and Collaborators

Takeda Global Research & Development Center, Inc.

Investigators

Study Director:

VP Clinical Science Strategy

Takeda Global Research & Development Center, Inc.

More Information

Additional Information:

ACTOS® Package Insert This link exits the ClinicalTrials.gov site

FDA Safety Alerts and Recalls This link exits the ClinicalTrials.gov site

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. Erratum in: Diab Vasc Dis Res. 2006 Sep;3(2):71.

Responsible Party:	Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00672919 History of Changes
Other Study ID Numbers:	01-03-TL-OPI-523, U1111-1115-8914
Study First Received:	May 2, 2008
Last Updated:	July 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Takeda Global Research & Development Center, Inc.:

Glucose Metabolism Disorder
Dysmetabolic Syndrome
Type II Diabetes

Diabetes Mellitus, Lipoatrophic
Dyslipidemia
Drug Therapy

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Dyslipidemias
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

Lipid Metabolism Disorders
Pioglitazone
Rosiglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012