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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Body Weight Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urogenital Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sitagliptin and metformin

Drug

Other names: Janumet

metformin

Drug

Other names: Glucophage

Primary outcomes

Change in body weight.

Time frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.

Secondary outcomes

Change in body mass indey (BMI).

Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 21, 2016
Registry last updated: Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed