Safety and Tolerability of Pioglitazone-Azilsartan in Subjects With Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT01124656|
Recruitment Status : Terminated (Formulation issues.)
First Posted : May 17, 2010
Last Update Posted : May 21, 2012
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Pioglitazone-Azilsartan||Phase 3|
AD-4833-536 is a combination of AD-4833 (pioglitazone) and TAK-536 (azilsartan). Pioglitazone is an oral antidiabetic agent that acts by reducing insulin resistance and approved for treatment of adult patients with type 2 diabetes mellitus. Azilsartan is a angiotensin II receptor blocker that modulates the renin-angiotensin-aldosterone system that regulates blood pressure. In a recent clinical trial conducted in subjects with moderately poor to poor control of their type 2 diabetes mellitus, azilsartan coadministered with pioglitazone showed a reduction in hemoglobin A1C and fasting plasma glucose levels.
After a one week screening period, subjects will be stratified to receive a starting dose of pioglitazone-azilsartan (30 mg + 20 mg or 45 mg + 20 mg).
The planned open-label treatment period was 52 weeks; however due to formulation issues, the study was prematurely discontinued and efficacy data were not analyzed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A One-Year Phase 3, Open-Label Study to Evaluate the Safety and Tolerability of AD 4833-536 in Subjects With Type 2 Diabetes|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Experimental: Pioglitazone-Azilsartan QD
(Dependent on glycosylated hemoglobin level at screening)
Pioglitazone-Azilsartan (30 mg + 20 mg) or (45 mg + 20 mg), tablets, orally, once daily for up to 52 weeks.
- Incidence of Adverse Events. [ Time Frame: On Occurrence (up to 52 Weeks). ]The Incidence of Treatment-Emergent Adverse Events, with an incidence > 5%.
- Change from Baseline for Glycosylated Hemoglobin. [ Time Frame: Baseline and Weeks 4, 8, 12, 16, 24, 32, 40, 48 and 52. ]The change between the value of Glycosylated Hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at each week indicated including final visit, and Glycosylated Hemoglobin collected at baseline.
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): NCT01124656
|Study Director:||VP, Clinical Science||Takeda|