Comparison of Alogliptin Versus Alogliptin and Pioglitazone on Insulin Resistance of Metformin Treated Women With PCOS

Study Overview
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Brief Summary
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The purpose of this study was to determine whether dual treatment with metformin and alogliptin is more effective than treatment with metformin, alogliptin and pioglitazone in the treatment of obese women with polycystic ovary syndrome (PCOS) regarding insulin resistance and beta cell function.

Conditions
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Polycystic Ovary Syndrome, Insulin Resistance

Intervention / Treatment
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* Drug: Vipdomet
* Drug: Incresync


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old to menopause polycystic ovary syndrome (NICHD criteria) BMI of 30 kg/m² or higher Exclusion Criteria: type 1 or type 2 diabetes mellitus history of carcinoma Cushing's syndrome or congenital (non-classic) adrenal hyperplasia personal or family history of MEN 2 significant cardiovascular, kidney or hepatic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metformin and alogliptin<br>Vipdomet 12.5 mg/1000 mg tablets | Drug: Vipdomet<br> <br> |
| Experimental: pioglitasone and alogliptin<br>Incresync 12,5 mg/30 mg tablets | Drug: Incresync<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR). | HOMA IR was calculated as the product of the fasting glucose and insulin concentration divided by 22,5. | HOMA IR was calculated at the base point and at the endpoint of 12 weeks of clinical trial. | 
| Primary outcome was change in beta cell function using adaptation index. | Adaptation index was calculated using the product between prehepatic insulin delivery and oral glucose insulin sensitivity (OGIS), calculated using online calculator. | Adaptation index was calculated at the base point and at the endpoint of 12 weeks of clinical trial. | 
| Primary outcome was change in fasting concentration of glucose. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting glucose was measured in mmol/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. | 
| Primary outcome was change in fasting concentration of insulin. | Patient's blood was drawn between 8 and 9 a.m. Concentrations of fasting insulin was measured in mU/L. | Patient's fasting blood was drawn at the base point and at the endpoint of 12 weeks of clinical trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome was change in body mass index (BMI). | Patient's BMI was defined as the patient's body mass in kilograms divided by the square of their height in meters. | 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 |