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

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Interventions: Drug: Incresync; Drug: Vipdomet

• Registration Number: NCT02683226
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-02
• Study Start: 2015-03
• Primary Completion: 2015-06
• Study Completion: 2015-07
• Study First Submitted: 2016-02-11
• Study First Submitted QC: 2016-02-16
• Study First Posted: 2016-02-17
• Last Update Submitted: 2016-05-10
• Last Update Posted: 2016-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pioglitasone and alogliptin	Incresync	Incresync 12,5 mg/30 mg tablets
metformin and alogliptin	Vipdomet	Vipdomet 12.5 mg/1000 mg tablets

Primary Outcome Measures

Name	Time	Method
The main outcome was change in insulin resistance measured with homeostasis model assessment (HOMA IR).	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.	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.	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.	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 Measures

Name	Time	Method
Secondary outcome was change in body mass index (BMI).	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.

Trial Locations

Locations (1)

University Medical Center Ljubljana; 🇸🇮 Ljubljana, Slovenia