Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients

NCT ID: NCT04029272

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-20
• Study Completion Date: 2020-12-31

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Metformin

Background 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.

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

500 mg tid for 12 weeks

Metformin+EQW

Background 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

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

500 mg tid for 12 weeks

Exenatide 2 MG

Intervention Type: DRUG

Exenatide injection once weekly for 12 weeks

Interventions

Metformin

500 mg tid for 12 weeks

Intervention Type: DRUG

Exenatide 2 MG

Exenatide injection once weekly for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Glucophage; Bydureon

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subjects have participated in other clinical researches of medicine within 1 month prior to randomization.
• Use of metformin, glucagon-like peptide -1 receptor agonists, or weight loss medications (prescription or OTC) within 30 days before screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Aijun Sun

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Deng

Role: CONTACT

yanndeng@163.com

13167559763

Aiju Sun

Role: CONTACT

References

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.

Reference Type: DERIVED

PMID: 40843067 (View on PubMed)

Ma 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.

Reference Type: DERIVED

PMID: 34732660 (View on PubMed)

Other Identifiers

PCOS201907

Identifier Type: -

Identifier Source: org_study_id