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

Primary Purpose

Polycystic Ovary Syndrome, Obesity

Status

Completed

Phase

Phase 4

Locations

Slovenia

Study Type

Interventional

Intervention

liraglutide

metformin and liraglutide

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

University Medical Center Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

liraglutide

metformin and liraglutide

Arm Description

liraglutide 3 mg QD for 12 weeks

metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks

Outcomes

Primary Outcome Measures

The main outcome was change in body weight.

Secondary Outcome Measures

The secondary outcome was change in body mass index (BMI)

Full Information

NCT ID

NCT02909933

First Posted

September 13, 2016

Last Updated

September 16, 2016

Sponsor

University Medical Centre Ljubljana

1. Study Identification

Unique Protocol Identification Number

NCT02909933

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

July 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Medical Centre Ljubljana

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome, Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

liraglutide

Arm Type

Experimental

Arm Description

liraglutide 3 mg QD for 12 weeks

Arm Title

metformin and liraglutide

Arm Type

Experimental

Arm Description

metformin 1000 mg BID and liraglutide 1.2 mg QD for 12 weeks

Intervention Type

Drug

Intervention Name(s)

liraglutide

Other Intervention Name(s)

Victoza

Intervention Type

Drug

Intervention Name(s)

metformin and liraglutide

Other Intervention Name(s)

Glucophage and Victoza

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrej Janez, MD PhD

Organizational Affiliation

University Medical Centre Ljubljana

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Ljubljana

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

28143456

Citation

Jensterle M, Kravos NA, Goricar K, Janez A. Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial. BMC Endocr Disord. 2017 Jan 31;17(1):5. doi: 10.1186/s12902-017-0155-9.

Results Reference

derived

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

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