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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
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring DPP4-inhibitors

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept 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

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

    First Posted
    October 18, 2016
    Last Updated
    October 20, 2016
    Sponsor
    University Medical Centre Ljubljana
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    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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