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

NCT ID: NCT02941445

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

Polycystic Ovary Syndrome; Body Weight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COMBO (sitagliptin and metformin)

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

Group Type: EXPERIMENTAL

sitagliptin and metformin

Intervention Type: DRUG

MET (metformin)

metformin 1000 mg BID

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

Interventions

sitagliptin and metformin

Intervention Type: DRUG

Metformin

Intervention Type: DRUG

Other Intervention Names

Janumet; Glucophage

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Medical Centre Ljubljana

OTHER

Sponsor Role: lead

Responsible Party

Andrej Janez

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrej Janež, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Centre Ljubljana

Other Identifiers

SITA after LIRA

Identifier Type: -

Identifier Source: org_study_id