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

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Medical Centre Ljubljana
• Treatments: Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate

Criteria

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