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

NCT02683226 | Completed Phase 4

• 1 other identifier: MTT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• 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

Study Arms (2)

metformin and alogliptin

EXPERIMENTAL

Vipdomet 12.5 mg/1000 mg tablets

Drug: Vipdomet

pioglitasone and alogliptin

EXPERIMENTAL

Incresync 12,5 mg/30 mg tablets

Drug: Incresync

Interventions

Vipdomet DRUG

metformin and alogliptin

Incresync DRUG

pioglitasone and alogliptin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old to menopause
• polycystic ovary syndrome (NICHD criteria)
• BMI of 30 kg/m² or higher

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Andrej Janez, MD, PhD

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: February 17, 2016
• Study Start: March 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: May 11, 2016

Record last verified: 2015-02

Locations

SL (1)