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

University Medical Centre Ljubljana

Status and phase: Completed; Phase 4

Conditions: Polycystic Ovary Syndrome; Body Weight

Treatments: Drug: sitagliptin and metformin; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT02941445

SITA after LIRA

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

24 participants in 2 patient groups

COMBO (sitagliptin and metformin)

Experimental group

Description:

metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks

Treatment:

Drug: sitagliptin and metformin

MET (metformin)

Experimental group

Description:

metformin 1000 mg BID

Treatment:

Drug: Metformin