Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
Primary Purpose
Polycystic Ovary Syndrome, Body Weight
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
sitagliptin and metformin
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring DPP4-inhibitors
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
COMBO (sitagliptin and metformin)
MET (metformin)
Arm Description
metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks
metformin 1000 mg BID
Outcomes
Primary Outcome Measures
Change in body weight.
Secondary Outcome Measures
Change in body mass indey (BMI).
The BMI was calculated as the body mass divided by the square of the body height (kg/m2)
Full Information
NCT ID
NCT02941445
First Posted
October 18, 2016
Last Updated
October 20, 2016
Sponsor
University Medical Centre Ljubljana
1. Study Identification
Unique Protocol Identification Number
NCT02941445
Brief Title
Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Body Weight
Keywords
DPP4-inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
COMBO (sitagliptin and metformin)
Arm Type
Experimental
Arm Description
metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks
Arm Title
MET (metformin)
Arm Type
Experimental
Arm Description
metformin 1000 mg BID
Intervention Type
Drug
Intervention Name(s)
sitagliptin and metformin
Other Intervention Name(s)
Janumet
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage
Primary Outcome Measure Information:
Title
Change in body weight.
Time Frame
Patient's body weight was measured at the baseline and after 12 weeks of clinical trial.
Secondary Outcome Measure Information:
Title
Change in body mass indey (BMI).
Description
The BMI was calculated as the body mass divided by the square of the body height (kg/m2)
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrej Janež, MD PhD
Organizational Affiliation
University Medical Centre Ljubljana
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Weight Maintenance With Dipeptidyl Peptidase 4 (DPP4) Inhibitor Sitagliptin in Combination With Metformin After Liragludite Induced Weight Loss
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