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

Last updated: July 21, 2019
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Polycystic Ovarian Syndrome

Reproductive Health

Obesity

Treatment

N/A

Clinical Study ID

NCT04029272
PCOS201907
  • Ages 18-40
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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, andhyperprolactinemia

  • Diagnosed with or have a family history of medullary thyroid carcinoma (MTC) orMultiple 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 monthprior to randomization.

  • Use of metformin, glucagon-like peptide -1 receptor agonists, or weight lossmedications (prescription or OTC) within 30 days before screening.

Study Design

Total Participants: 80
Study Start date:
July 20, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 1000730
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.