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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00672919
First received: May 2, 2008
Last updated: February 27, 2012
Last verified: February 2012
  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 4

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:


Further study details as provided by Takeda:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 53 Study Locations
Sponsors and Collaborators
Takeda
Investigators
Study Director: VP Clinical Science Strategy Takeda
  More Information

Additional Information:
Publications:
Responsible Party: Takeda
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: February 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
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 July 23, 2014