Skip to content

Trial · Interventional

CompletedPhase 4Registry data

Research of Exenatide for Overweight/Obese PCOS Patients With IGR

NCTNCT03352869 (opens ClinicalTrials.gov in a new tab)Other id[2017]077
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
183 participants (actual)
Sponsor
RenJi Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
28 Nov 2017
Primary completion
1 Jul 2018
Completion
31 Jul 2018
First posted
24 Nov 2017
Last update posted
11 Sept 2019
Conditions
Polycystic Ovary Syndrome · Overweight and Obesity · Disorder of Glucose Regulation

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019
  1. Ph 4

    Research of Exenatide for Overweight/Obese PCOS Patients With IGR

    NCT03352869

    28 Nov 2017 to 31 Jul 2018

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Compare the therapeutic effects of exenatide, metformin and their combination for 3 months on reproductive and metabolic improvements of overweight/obese PCOS patients with impaired glucose regulation.

Interventions

  • ExenatideDrug
  • MetforminDrug

Arms3

  • Experimental

    Exenatide

    Drug: Byetta Generic name: Exenatide Dosage form: 5ug and 10ug Dosage: 10-20ug/day Frequency: twice a day Duration: 3 months

  • Active comparator

    Metformin

    Drug: Glucophage Generic name: Metformin Dosage form: 500mg Dosage: 1500-2000mg/day Frequency: 500mg three times a day/1000mg twice a day Duration: 3 months

  • Experimental

    Combination

    Drug: Byetta and Glucophage Generic name: Exenatide Dosage form: Exenatide 5ug and 10ug; Metformin 500mg Dosage: Exenatide10-20ug/day; Metformin 1500-2000mg/day Frequency: Exenatide twice a day; Metformin 500mg three times a day/1000mg twice a day Duration: 3 months

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation

    Time frame · up to 12 weeks

    Registry description

    To compare the intravenous blood glucose of three groups 12 weeks after withdrawal. All patients discontinue after 12 weeks of treatment and only routine lifestyle intervention is performed after that. All patients receive 75 g OGTT test and insulin releasing test again 12 weeks after drug withdrawal to observe the IGR remission rate. To accurately assess the insulin secretion of islet β-cell, 13 patients would be randomly selected from MET group and from EX group respectively to receive the two-step hyperglycemic clamp before the intervention and after 12-week treatment. Remission rate = Number of patients who has normal glucose tolerance 12 weeks after withdrawal / Number of patients who completed treatments × 100%

Secondary outcomes(3)

  1. Improvement of hyperandrogenism

    Time frame · up to 12 weeks

    Registry description

    To compare the free androgen index (FAI =total serum testosterone x 100 / Sex Hormone Binding Globulin) of three groups after 12-week treatment

  2. Improvement of blood lipid

    Time frame · up to 12 weeks

    Registry description

    To compare the circulating lipid level(triglyceride, total cholesterol, HDL-C, LDL-C, etc.) of three groups after 12-week treatment

  3. Improvement of fatty liver

    Time frame · up to 12 weeks

    Registry description

    To compare the number of fatty liver patients diagnosed by ultrasonography of three groups after 12-week treatment

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

6 studies on this page

Indexing hint: Randomized controlled trial · 2021

5 results

Exenatide, Metformin, or Both for Prediabetes in PCOS: A Randomized, Open-label, Parallel-group Controlled Study.

Tao et al. 2021The Journal of clinical endocrinology and metabolismcited by 42

PMID 32995892PMC8244122DOI 10.1210/clinem/dgaa692PUB-32995892

Rights unknown5 results
Source linkSee results (5)

Indexing hint: Randomized controlled trial · 2017

8 results

Short-term effectiveness of low dose liraglutide in combination with metformin versus high dose liraglutide alone in treatment of obese PCOS: randomized trial.

Jensterle et al. 2017BMC endocrine disorderscited by 58

PMID 28143456PMC5286837DOI 10.1186/s12902-017-0155-9PUB-28143456

CC BY8 results
Download PDFSee results (8)

Indexing hint: Clinical trial · 2015

6 results

Short-term intervention with liraglutide improved eating behavior in obese women with polycystic ovary syndrome.

Jensterle et al. 2015Endocrine researchcited by 66

PMID 25330463DOI 10.3109/07435800.2014.966385PUB-25330463

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Clinical trial · 2015

16 results

The effects of treatment with liraglutide on atherothrombotic risk in obese young women with polycystic ovary syndrome and controls.

Kahal et al. 2015BMC endocrine disorderscited by 59

PMID 25880805PMC4389314DOI 10.1186/s12902-015-0005-6PUB-25880805

CC BY16 results
Download PDFSee results (16)

Indexing hint: Randomized controlled trial · 2014

15 results

Short-term combined treatment with liraglutide and metformin leads to significant weight loss in obese women with polycystic ovary syndrome and previous poor response to metformin.

Jensterle Sever et al. 2014European journal of endocrinologycited by 124

PMID 24362411PMC3922503DOI 10.1530/eje-13-0797PUB-24362411

CC BY15 results
Download PDFSee results (15)

Indexing hint: Randomized controlled trial · 2008

13 results

Comparison of single and combined treatment with exenatide and metformin on menstrual cyclicity in overweight women with polycystic ovary syndrome.

Elkind-Hirsch et al. 2008The Journal of clinical endocrinology and metabolismcited by 200

PMID 18460557DOI 10.1210/jc.2008-0115PUB-18460557

Full text at the publisher13 results
Publisher pageSee results (13)

More studies

1 study on this page

PubMed tag: none · 2014

Glucagon-like peptide-1 analogue, liraglutide, improves liver fibrosis markers in obese women with polycystic ovary syndrome and nonalcoholic fatty liver disease.

Kahal et al. 2014Clinical endocrinologycited by 60

PMID 24256515DOI 10.1111/cen.12369PUB-24256515

Full text at the publisher
Publisher page

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. have PCOS which is diagnosed according to 2003 Rotterdam criteria; 2. overweight / obesity diagnostic criteria is based on WHO-WPR ; 3. IGR diagnostic criteria is based on 1999 WHO diagnostic criteria; 4. have been treated with dietary and behavioral intervention for 3 months but are ineffective; 5. have no use of other hypoglycemic drugs before 3 months of treatment. Exclusion Criteria: * Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) * high blood pressure (\>160/100mmHg) * active infection * secondary diabetes * pregnancy * alcohol abuse * allergic to GLP-1 receptor agonist or metformin

PepBank is a research reference. Talk to a doctor before you use any peptide.