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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Unknown; Phase 4

Conditions: Polycystic Ovary Syndrome

Treatments: Drug: Metformin; Drug: Exenatide 2 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04029272

PCOS201907

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Metformin

Active Comparator group

Description:

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.

Treatment:

Drug: Metformin

Metformin+EQW

Experimental group

Description:

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

Treatment:

Drug: Exenatide 2 MG

Drug: Metformin