Sitagliptin Improved Beta Cell Function and Prevented a Conversion Rate to Impaired Glucose Tolerance and Type 2 Diabetes in Metformin Intolerant Obese Women With Polycystic Ovary Syndrome

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: PCOS

Treatments: Drug: Sitagliptin; Behavioral: Lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03122041

Metformin Intolerant PCOS

Details and patient eligibility

About

Metformin is the first-line therapy for PCOS with high metabolic risk, yet a large proportion of patients cannot tolerate it due to associated gastrointestinal adverse events. The alternative pharmacological strategy when metformin cannot be tolerated is not well established in this population. Our aim was to evaluate whether sitagliptin (SITA) preserves metabolic profile in metformin (MET) intolerant PCOS with high metabolic risk.

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 (ASRM-ESHRE Rotterdam criteria)
• BMI of 30 kg/m2 or higher

Exclusion criteria

• significant cardiovascular disease
• significant kidney or hepatic disease
• personal or family history of medullary thyroid carcinoma
• known history of gallbladder disease
• known history of pancreatitis

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

SITA

Experimental group

Description:

Sitagliptin (SITA) Lifestyle intervention and sitagliptin 100mg per day for 12 weeks

Treatment:

Behavioral: Lifestyle intervention

Drug: Sitagliptin

CON

Experimental group

Description:

Controls (CON) Lifestyle intervention

Treatment:

Behavioral: Lifestyle intervention