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

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)

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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