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

NCT ID: NCT02683226

Last Updated: 2016-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-07-31

Brief Summary

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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

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Conditions

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Polycystic Ovary Syndrome Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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metformin and alogliptin

Vipdomet 12.5 mg/1000 mg tablets

Group Type EXPERIMENTAL

Vipdomet

Intervention Type DRUG

pioglitasone and alogliptin

Incresync 12,5 mg/30 mg tablets

Group Type EXPERIMENTAL

Incresync

Intervention Type DRUG

Interventions

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Vipdomet

Intervention Type DRUG

Incresync

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Andrej Janez

Andrej Janez, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Center Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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MTT

Identifier Type: -

Identifier Source: org_study_id

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