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Low Dose Liraglutide and Metformin vs. High Dose Liraglutide Alone in Treatment of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02909933
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : September 21, 2016
Sponsor:
Information provided by (Responsible Party):
Andrej Janez, University Medical Centre Ljubljana

Brief Summary:

Weight reduction is the most important treatment target when polycystic ovary syndrome (PCOS) is linked to obesity. Liraglutide (LIRA) in dose of 3 mg was recently approved as an anti-obesity drug. Metformin could enhance weight lowering potential of liraglutide.

We investigates short term interventions with low dose liraglutide in combination with metformin and high dose liraglutide alone influence on significant weight reduction in obese women with PCOS.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Obesity Drug: liraglutide Drug: metformin and liraglutide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : July 2015
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: liraglutide
liraglutide 3 mg QD for 12 weeks
Drug: liraglutide
Other Name: Victoza

Experimental: metformin and liraglutide
metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks
Drug: metformin and liraglutide
Other Name: Glucophage and Victoza




Primary Outcome Measures :
  1. The main outcome was change in body weight. [ Time Frame: Patient's body weight was measured at the base point and after 12 weeks of clinical trial. ]

Secondary Outcome Measures :
  1. The secondary outcome was change in body mass index (BMI) [ Time Frame: Patient's body weight were measured at the base point and after 12 weeks of clinical trial. Patient's height was measured at the base point. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 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 30 kg/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 MEN 2
  • significant cardiovascular, kidney or hepatic disease
  • the use of medications known or suspected to affect reproductive or metabolic functions
  • 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): NCT02909933


Locations
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Slovenia
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Andrej Janez, MD PhD University Medical Centre Ljubljana
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrej Janez, MD PhD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02909933    
Other Study ID Numbers: COMBO - LIRA 3
First Posted: September 21, 2016    Key Record Dates
Last Update Posted: September 21, 2016
Last Verified: June 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists