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

U

University Medical Centre Ljubljana

Status and phase

Completed
Phase 4

Conditions

Insulin Resistance
Polycystic Ovary Syndrome

Treatments

Drug: Vipdomet
Drug: Incresync

Study type

Interventional

Funder types

Other

Identifiers

NCT02683226
MTT

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

metformin and alogliptin
Experimental group
Description:
Vipdomet 12.5 mg/1000 mg tablets
Treatment:
Drug: Vipdomet
pioglitasone and alogliptin
Experimental group
Description:
Incresync 12,5 mg/30 mg tablets
Treatment:
Drug: Incresync

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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