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Completed

NCT Number: NCT02683226

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Gonadal Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vipdomet

Drug

Incresync

Drug

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Feb 17, 2016
Registry last updated
May 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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