Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome; Body Weight
• Interventions: Drug: sitagliptin and metformin; Drug: Metformin

• Registration Number: NCT02941445
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

Weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (PCOS), yet it is usually hardly achievable with lifestyle intervention alone. Glucagon-like peptide 1 (GLP-1) receptor agonist (RA) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. In addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. Although DPP-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with GLP-1 RAs if they were switched to DPP-4 inhibitor rather than placebo. The aim is to evaluate whether DPP-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese PCOS who had been previously treated with liraglutide.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-20
• Last Update Submitted: 2016-10-20
• Study First Posted: 2016-10-21
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• 18 years old to menopause
• polycystic ovary syndrome (NICHD criteria)
• BMI of 30kg/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 multiple endocrine neoplasia type 2
• significant cardiovascular, kidney or hepatic disease
• the use of statins, within 90 days prior to study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
COMBO (sitagliptin and metformin)	sitagliptin and metformin	metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks
MET (metformin)	Metformin	metformin 1000 mg BID

Primary Outcome Measures

Name	Time	Method
Change in body weight.	Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.

Secondary Outcome Measures

Name	Time	Method
Change in body mass indey (BMI).	Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.	The BMI was calculated as the body mass divided by the square of the body height (kg/m2)