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

Polycystic Ovary Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02941445
• Other study ID #: SITA after LIRA
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2016
• Last updated: October 20, 2016
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2015
• Source: University Medical Centre Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovenia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Polycystic Ovary Syndrome

Intervention

Drug:
• sitagliptin and metformin

• Metformin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight.		Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.	No
Secondary	Change in body mass indey (BMI).	The BMI was calculated as the body mass divided by the square of the body height (kg/m2)	Patient's body height was measured at the baseline. Body weight was measured at the baseline and after 12 weeks of clinical trial.	No