Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
Study on the Effect of Metformin vs Metformin Combined With GLP-1 RA (Exenatide) on Overweight/Obese Patients With Polycystic Ovary Syndrome (PCOS)
1 other identifier
interventional
80
1 country
1
Brief Summary
The purpose of this study was to determine whether metformin combined with exenatide once weekly (EQW) is more effective than metformin alone in the treatment of overweight/obese women with polycystic ovary syndrome (PCOS). Background therapies were Diane-35 or/and progesterone capsule. 80 participants were randomized to use either metformin or metformin+EQW for 12 weeks. Greater changes in body weight were anticipated in patients treated with EQW+metformin than metformin alone in those treated with metformin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2019
CompletedStudy Start
First participant enrolled
July 20, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJuly 23, 2019
July 1, 2019
7 months
July 8, 2019
July 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in body weight
Patient's body weight was measured at the baseline and after 12 weeks of clinical trial
Secondary Outcomes (27)
Proportion of subjects who lost ≥5% of their body weight
12 weeks
Proportion of subjects who lost ≥ 10% of their body weight
12 weeks
Change in body mass index (BMI)
12 weeks
Change in waist circumference(WC)
12 weeks
Change in hip circumference (HC)
12 weeks
- +22 more secondary outcomes
Study Arms (2)
Metformin
ACTIVE COMPARATORBackground therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d.
Metformin+EQW
EXPERIMENTALBackground therapy: Diane-35 one pill by mouth, once daily, beginning on Day 5 of the menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles (3 months) Metformin: Metformin was initiated at a dose of 250mg q.d. and increased by 250mg up to 500 mg t.i.d. EQW: Participants will receive long-acting Exenatide once a week for 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Females 18 years to 40 years of age
- Diagnosed as PCOS by the 2003 Rotterdam criteria.
- Overweight/obesity (BMI≥25 kg/m2)
- No pregnant plan in recent 6 months
- Written consent for participation in the study
You may not qualify if:
- type 1 or type 2 diabetes mellitus
- Subjects have other endocrine diseases, such as adrenal hyperplasias or tumor, androgen-secreting tumors, Cushing's syndrome, thyroid diseases, and hyperprolactinemia
- Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Serious systemic disease or malignant tumor
- History of pancreatitis (chronic, acute or recurrent)
- Body weight change ≥10% at 3 months before treatment
- Used oral contraceptives or sex hormone drugs in the past 1 month
- Used oral glucocorticoids in the past 1 month
- Substance (alcohol or drug) abuse or dependence within 3 months; Heavy smokers (smokers who smoke 20 or more cigarettes a day) or heavy drinkers (\>10g/d)
- Subjects have a severe systemic disease, such as cardiovascular system
- Renal impairment, eGFR\<60ml/min/1.73m2
- Increase of transaminases up to \< 2.5 times of upper limit of normal value
- Have a history of thromboembolic disease or thrombotic tendency
- Subjects in pregnant or lactating or within 1 year after delivery.
- Subjects have an allergic history to the drugs used in the study
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 1000730, China
Related Publications (2)
Xuesong D, Tao T, Weilu W, Wei X, Wei X, Yan D, Yanfang W, Ruilin M, Yingying G, Yue W, Perez-Lopez FR, Yang W. Combined metformin and exenatide versus only metformin treatments in polycystic ovary syndrome with abdominal obesity and network pharmacology of gene expression: evidence from a randomized clinical trial. Ther Adv Endocrinol Metab. 2025 Aug 19;16:20420188251355411. doi: 10.1177/20420188251355411. eCollection 2025.
PMID: 40843067DERIVEDMa RL, Deng Y, Wang YF, Zhu SY, Ding XS, Sun AJ. Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome. Chin Med J (Engl). 2021 Nov 3;134(23):2882-2889. doi: 10.1097/CM9.0000000000001712.
PMID: 34732660DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Aiju Sun
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 8, 2019
First Posted
July 23, 2019
Study Start
July 20, 2019
Primary Completion
February 28, 2020
Study Completion
December 31, 2020
Last Updated
July 23, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share