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

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ClinicalTrials.gov Identifier: NCT02941445
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Body Weight Drug: sitagliptin and metformin Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
Experimental: COMBO (sitagliptin and metformin)
metformin 1000 mg BID and sitagliptin 50mg BID for 12 weeks
Drug: sitagliptin and metformin
Other Name: Janumet

Experimental: MET (metformin)
metformin 1000 mg BID
Drug: Metformin
Other Name: Glucophage




Primary Outcome Measures :
  1. Change in body weight. [ Time Frame: Patient's body weight was measured at the baseline and after 12 weeks of clinical trial. ]

Secondary Outcome Measures :
  1. Change in body mass indey (BMI). [ 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. ]
    The BMI was calculated as the body mass divided by the square of the body height (kg/m2)



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02941445


Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Andrej Janež, MD PhD University Medical Centre Ljubljana

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Responsible Party: Andrej Janez, MD PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02941445     History of Changes
Other Study ID Numbers: SITA after LIRA
First Posted: October 21, 2016    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrej Janez, University Medical Centre Ljubljana:
DPP4-inhibitors

Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Body Weight
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Signs and Symptoms
Metformin
Sitagliptin Phosphate
Dipeptidyl-Peptidase IV Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action