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

Insulin Resistance Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02683226
• Other study ID #: MTT
• Status: Completed
• Phase: Phase 4
• First received: February 11, 2016
• Last updated: May 10, 2016
• Start date: March 2015
• Est. completion date: July 2015

Study information

• Verified date: February 2015
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome

Intervention

Drug:
• Vipdomet

• Incresync

Locations

Country	Name	City	State
Slovenia	University Medical Center Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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.	No
Primary	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.	No
Primary	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.	No
Secondary	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	No