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

• Status: Unknown status
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Exenatide; Glucagon; Glucagon-Like Peptide 1; Metformin

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.