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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02941445

Enrollment

Registered

2016-10-21

Start date

2015-10-31

Completion date

2016-08-31

Last updated

2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Weight, Polycystic Ovary Syndrome

Keywords

DPP4-inhibitors

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.

Interventions

DRUGsitagliptin and metformin

DRUGMetformin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026