Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS
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|ClinicalTrials.gov Identifier: NCT02683226|
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : May 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome Insulin Resistance||Drug: Vipdomet Drug: Incresync||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||July 2015|
Experimental: metformin and alogliptin
Vipdomet 12.5 mg/1000 mg tablets
Experimental: pioglitasone and alogliptin
Incresync 12,5 mg/30 mg tablets
- The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR). [ Time Frame: HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial. ]HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5.
- Primary outcome was change in beta cell function using adaptation index. [ Time Frame: Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial. ]Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator.
- Primary outcome was change in fasting concentration of glucose. [ Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. ]Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L.
- Primary outcome was change in fasting concentration of insulin. [ Time Frame: Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. ]Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L.
- Secondary outcome was change in body mass index (BMI). [ Time Frame: Patient's body weight were measured at the base point and every four weeks during the 12 weeks of clinical trial. Patient's height was measured at the basepoint ]Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683226
|University Medical Center Ljubljana|
|Ljubljana, Slovenia, 1000|