Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00331487
Status:
COMPLETED
Last Update Posted:
2012-02-28
First Post:
2006-05-30
Brief Title:
Study to Compare Pioglitazone and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Pioglitazone Versus Rosiglitazone in Subjects With Type 2 Diabetes Mellitus and Dyslipidemia
Status:
COMPLETED
Status Verified Date:
2012-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Efficacy comparison of Pioglitazone once daily QD to Rosiglitazone in participants with Type 2 Diabetes
Detailed Description:
At least two metabolic defects contribute to the development of type 2 diabetes mellitus relative insulin insufficiency and insulin resistance The majority of patients with type 2 diabetes mellitus demonstrate some degree of insulin resistance Even in the absence of hyperglycemia high blood sugar insulin resistance is associated with a cluster of metabolic abnormalities that increase the risk for cardiovascular disease including dyslipidemia unhealthy blood fat increased expression of inflammatory markers activation of pro-coagulants pro-clotting hemodynamic changes and endothelial dysfunction
The dyslipidemia associated with insulin resistance and type 2 diabetes mellitus is characterized by elevated triglyceride levels and decreased high-density lipoprotein good cholesterol levels Although low-density lipoprotein bad cholesterol levels may not be significantly elevated in patients with type 2 diabetes mellitus an increase in the proportion of small dense low-density lipoprotein cholesterol particles of increased atherogenicity increased formation of lipid deposits in the arteries is observed When compared with individuals without type 2 diabetes mellitus the risk of cardiovascular disease is 2- to 4-fold greater in patients with type 2 diabetes mellitus and the dyslipidemia of diabetes is an important contributor to the increased risk in this population
By targeting the insulin resistance underlying type 2 diabetes mellitus the thiazolidinedione class of oral antihyperglycemic medications possesses both a glucose-lowering effect and the potential to alter lipidlipoprotein metabolism Two thiazolidinediones are currently available for the treatment of type 2 diabetes mellitus pioglitazone hydrochloride ACTOS Takeda Pharmaceuticals North America Inc Lincolnshire IL and rosiglitazone maleate Avandia GlaxoSmithKline Research Triangle Park NC
The purpose of this study is to evaluate the triglyceride-lowering effects of pioglitazone to rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia who are not receiving any other glucose- or lipid-lowering therapies at the same time as the study medications
Individuals who participate in this study will provide written informed consent and will be required to commit to a screening visit and approximately 7 additional visits at the study center Study participation is anticipated to be about 39 weeks or approximately 8 months Multiple procedures will occur at each visit which may include fasting blood collection physical examinations and electrocardiograms Participants will be required to follow a diabetic diet self-monitor their blood glucose and maintain a study diary for the duration of the study
The dyslipidemia associated with insulin resistance and type 2 diabetes mellitus is characterized by elevated triglyceride levels and decreased high-density lipoprotein good cholesterol levels Although low-density lipoprotein bad cholesterol levels may not be significantly elevated in patients with type 2 diabetes mellitus an increase in the proportion of small dense low-density lipoprotein cholesterol particles of increased atherogenicity increased formation of lipid deposits in the arteries is observed When compared with individuals without type 2 diabetes mellitus the risk of cardiovascular disease is 2- to 4-fold greater in patients with type 2 diabetes mellitus and the dyslipidemia of diabetes is an important contributor to the increased risk in this population
By targeting the insulin resistance underlying type 2 diabetes mellitus the thiazolidinedione class of oral antihyperglycemic medications possesses both a glucose-lowering effect and the potential to alter lipidlipoprotein metabolism Two thiazolidinediones are currently available for the treatment of type 2 diabetes mellitus pioglitazone hydrochloride ACTOS Takeda Pharmaceuticals North America Inc Lincolnshire IL and rosiglitazone maleate Avandia GlaxoSmithKline Research Triangle Park NC
The purpose of this study is to evaluate the triglyceride-lowering effects of pioglitazone to rosiglitazone in patients with type 2 diabetes mellitus and dyslipidemia who are not receiving any other glucose- or lipid-lowering therapies at the same time as the study medications
Individuals who participate in this study will provide written informed consent and will be required to commit to a screening visit and approximately 7 additional visits at the study center Study participation is anticipated to be about 39 weeks or approximately 8 months Multiple procedures will occur at each visit which may include fasting blood collection physical examinations and electrocardiograms Participants will be required to follow a diabetic diet self-monitor their blood glucose and maintain a study diary for the duration of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1115-9039 | REGISTRY | WHO | None |