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

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT00672919

Collaborator

(none)

305

Enrollment

Locations

Arm

Duration (Months)

5.8

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Pioglitazone	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

305 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

Nov 1, 2003

Actual Primary Completion Date :

Aug 1, 2004

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Change from Baseline in Triglyceride Levels [Weeks 8 and 17 or Final Visit]

Secondary Outcome Measures

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]
Change from Baseline in Free Fatty Acids [Weeks 8 and 17 or Final Visit]
Change from Baseline in Lipid Fractionation [Weeks 8 and 17 or Final Visit]
Change from Baseline in C-reactive Protein [Weeks 8 and 17 or Final Visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	City	State	Country
1	Birmingham,	Alabama	United States
2	Tucson	Arizona	United States
3	Bellflower	California	United States
4	Burlingame	California	United States
5	Fresno,	California	United States
6	La Jolla	California	United States
7	Long Beach	California	United States
8	Pasadena	California	United States
9	Arvada	Colorado	United States
10	Norwalk	Connecticut	United States
11	Waterbury	Connecticut	United States
12	Aventura	Florida	United States
13	Hollywood	Florida	United States
14	Jacksonville	Florida	United States
15	Miami	Florida	United States
16	N. Miami Beach	Florida	United States
17	Tallahassee	Florida	United States
18	West Palm Beach	Florida	United States
19	Columbus,	Georgia	United States
20	Idaho Falls	Idaho	United States
21	Chicago Heights	Illinois	United States
22	Evansville,	Indiana	United States
23	Des Moines	Iowa	United States
24	Lafayette	Louisiana	United States
25	Fall River	Massachusetts	United States
26	Waltham	Massachusetts	United States
27	Tupelo	Mississippi	United States
28	Chesterfield	Missouri	United States
29	Omaha	Nebraska	United States
30	Staten Island	New York	United States
31	Raleigh	North Carolina	United States
32	Winston-Salem	North Carolina	United States
33	Centerville	Ohio	United States
34	Dayton	Ohio	United States
35	Medford	Oregon	United States
36	Meadville	Pennsylvania	United States
37	Pittsburgh	Pennsylvania	United States
38	Warwick	Rhode Island	United States
39	Chattanooga	Tennessee	United States
40	Morristown	Tennessee	United States
41	Murfreesboro	Tennessee	United States
42	Nashville	Tennessee	United States
43	Arlington	Texas	United States
44	Houston	Texas	United States
45	Midland	Texas	United States
46	San Antonio	Texas	United States
47	Ogden	Utah	United States
48	Orange	Virginia	United States
49	Virginia Beach,	Virginia	United States
50	Man	West Virginia	United States
51	Wausau	Wisconsin	United States
52	Carolina		Puerto Rico
53	PoncE		Puerto Rico