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

Study Overview
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Brief Summary
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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
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Polycystic Ovary Syndrome, Body Weight

Intervention / Treatment
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* Drug: sitagliptin and metformin
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COMBO (sitagliptin and metformin)<br>metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks | Drug: sitagliptin and metformin<br> <br> * Other names: Janumet;|
| Experimental: MET (metformin)<br>metformin 1000 mg BID | Drug: Metformin<br> <br> * Other names: Glucophage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight. |  | Patient's body weight was measured at the baseline and after 12 weeks of clinical trial. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DPP4-inhibitors