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

May 10, 2016 updated by: Andrej Janez, University Medical Centre Ljubljana
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Center Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.
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.
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.
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.
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.
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).
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 11, 2016

First Submitted That Met QC Criteria

February 16, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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