Efficacy of Pioglitazone and Fortamet Combination Therapy in Subjects With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT00754403|
Recruitment Status : Completed
First Posted : September 18, 2008
Last Update Posted : July 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Drug: Pioglitazone and metformin Drug: Metformin||Phase 4|
Pioglitazone (ACTOS®) is a member of a class of oral antidiabetic agents known as thiazolidinediones. The insulin-sensitizing actions of thiazolidinediones are at least partially mediated through the peroxisome proliferator-activated receptor gamma. These receptors are found primarily in adipocytes, vascular endothelial cells, monocytes, hepatocytes, and to a lesser extent myocytes.
Metformin was developed as an extended-release formulation of metformin hydrochloride and designed for once-a-day oral administration. Metformin is an antihyperglycemic agent, which improves glucose tolerance in patients with, type 2 diabetes, lowering both basal and postprandial plasma glucose.
On 15 July 1999, the FDA approved pioglitazone for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. Pioglitazone is indicated for monotherapy and for use in combination with sulfonylureas, metformin, or insulin when diet and exercise plus the single agent do not result in adequate glycemic control. On 26 November 2003, the FDA approved the combined use of pioglitazone with metformin.
This study is designed to evaluate the effect on glycemic control when pioglitazone and metformin are taken together. Individuals participating in this study will provide written informed consent and will be required to commit to a screening visit and approximately 5 additional visits at the study center. Study participation is anticipated to be about 31 weeks (or approximately 8 months). Multiple procedures will occur at each visit which may include fasting, blood collection, urine collection, physical examinations and electrocardiograms.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effects on Glycemic Control With Concomitantly Administered Pioglitazone HCl and Metformin HCl Extended Release (Fortamet®) in Subjects With Type 2 Diabetes|
|Study Start Date :||July 2005|
|Primary Completion Date :||October 2006|
|Study Completion Date :||October 2006|
|Experimental: Pioglitazone 30 mg QD + Metformin 1000 mg QD||
Drug: Pioglitazone and metformin
Pioglitazone 30 mg, tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.
|Active Comparator: Metformin 1000 mg QD||
Pioglitazone placebo-matching tablets, orally, once daily and metformin 1000 mg, tablets, orally once daily for up to 16 weeks.
Other Name: Fortamet
- Change from randomization in Glycosylated Hemoglobin [ Time Frame: Final Visit ]
- Change from randomization in Fasting Plasma Glucose [ Time Frame: Final Visit ]
- Change from randomization in Insulin [ Time Frame: Final Visit ]
- Change from randomization in Pro-Insulin [ Time Frame: Final Visit ]
- Change from randomization in Homeostasis Model Assessment [ Time Frame: Final Visit ]
- Change from randomization in Triglycerides [ Time Frame: Final Visit ]
- Change from randomization in Total Cholesterol [ Time Frame: Final Visit ]
- Change from randomization in Low-Density Lipoprotein Cholesterol [ Time Frame: Final Visit ]
- Change from randomization in high-density Lipoprotein Cholesterol [ Time Frame: Final Visit ]
- Change from randomization in Lipid Fractionation [ Time Frame: Final Visit ]
- Change from randomization in High Sensitivity C-Reactive Protein [ Time Frame: Final Visit ]
- Change from randomization in Creatine Phosphokinase [ Time Frame: Final Visit ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754403
|Study Director:||VP Clinical Science Strategy||Takeda|