Trial · Interventional

Status unknownPhase 4Registry data

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

NCTNCT04029272Other idPCOS201907

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Status unknown
Phase: Phase 4
Enrollment: 80 participants (estimated)
Sponsor: Peking Union Medical College Hospital · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 20 Jul 2019 (estimated)
Primary completion: 28 Feb 2020 (estimated)
Completion: 31 Dec 2020 (estimated)
First posted: 23 Jul 2019
Last update posted: 23 Jul 2019
Conditions: Polycystic Ovary Syndrome

Timeline

1 trial

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201920202021

Ph 4
Metformin vs Metformin Combined With GLP-1RA (Glucagon-like Peptide 1 Receptor Agonist) on Overweight/Obese PCOS Patients
NCT04029272
est. 20 Jul 2019 to est. 31 Dec 2020

Registry summary

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

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.

Interventions

MetforminDrug
Exenatide 2 MGDrug

Arms2

Active comparator
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.
Experimental
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

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in body weight
Time frame · Patient's body weight was measured at the baseline and after 12 weeks of clinical trial

Secondary outcomes(20)

Proportion of subjects who lost ≥5% of their body weight
Time frame · 12 weeks
Proportion of subjects who lost ≥ 10% of their body weight
Time frame · 12 weeks
Change in body mass index (BMI)
Time frame · 12 weeks
Change in waist circumference(WC)
Time frame · 12 weeks
Change in hip circumference (HC)
Time frame · 12 weeks
Changes in lipid accumulation product(LAP)
Time frame · 12 weeks
Registry description
LAP=(WC(cm)-58)×TG (mmol/L)
Changes in Visceral obesity index(VAI)
Time frame · 12 weeks
Registry description
VAI = (WC(cm)/39.68+(1.88×BMI))×(TG (mmol/l)/1.03)×(1.31/HDL (mmol/l))
Changes in blood pressure
Time frame · 12 weeks
Changes in Blood Glucose and Insulin During the oral glucose tolerance test (OGTT)
Time frame · 12 weeks
Registry description
glucose obtained at 0,30,60 and 120 minutes during the OGTT. HOMA-IR=Glu0(mmol/l)×Ins0(mU/ml)/22.5 Matsuda index=1000/ square(Ins0 (mU/ml) ×Glu0 (mmol/l)×mean Glu(mmol/l)×meanIns(mU/ml)\] QUICKI= 1/Log\[Glu0 (mU/ml) ×Ins0 (mmol/l)\] HOMA-β=20×Ins0 (mU/ml) /(Glu0 (mmol/l)-3.5) MBCI= Ins0 (mU/ml)×Glu0(mmol/l)／(Glu120(mmol/l)＋Glu60 (mmol/l)-2×Glu0 (mmol/l)） ΔI30/ΔG30 = (Ins30- Ins0)/( Glu30- Glu0)
Changes in total cholesterol (TC)
Time frame · 12 weeks
Changes in serum triglyceride (TG)
Time frame · 12 weeks
Changes in high-density lipoproteincholesterol (HDL-C)
Time frame · 12 weeks
Changes in low-density lipoproteincholesterol (LDL-C)
Time frame · 12 weeks
Changes in lipoprotein(a)
Time frame · 12 weeks
Changes in apolipoprotein a1(ApoA1)
Time frame · 12 weeks
Changes in apolipoprotein B(ApoB)
Time frame · 12 weeks
Changes in free fatty acid (FFA)
Time frame · 12 weeks
Changes in high sensitivity C reactive protein(hsCRP)
Time frame · 12 weeks
Frequency of menstrual cycle
Time frame · 12 weeks
Registry description
The number of menstrual cycles during the previous year was recorded and the menstrual cycle ratio calculated by dividing 12 by the number of menstrual cycles in the previous year . During the study period, the patients in a menstrual diary recorded vaginal bleeding over 12 weeks. The effects of treatment intervention on menstrual cycle interval was calculated evaluated by dividing 3 by the number of menstrual cycles recorded in each patient's menstrual cycle diary.
Changes in testosterone
Time frame · 12 weeks

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.

A trial that is still running, or that stopped early, may post results later.

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

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

7 results

Short-term combined treatment with exenatide and metformin for overweight/obese women with polycystic ovary syndrome.

Ma et al. 2021Chinese medical journalcited by 47

PMID 34732660PMC8667970DOI 10.1097/cm9.0000000000001712PUB-34732660

Free to read · publisher termsCC BY-NC-ND7 results

Read at source See results (7)

More studies

1 study on this page

PubMed tag: none · 2025

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.

Xuesong et al. 2025Therapeutic advances in endocrinology and metabolismcited by 2

PMID 40843067PMC12365428DOI 10.1177/20420188251355411PUB-40843067

Free to read · publisher termsCC BY-NC

Read at source

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 40 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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