SGLT2 Inhibitors in Patients With PCOS

Phase 4

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: SGLT2 inhibitors; Drug: Metformin

• Registration Number: NCT04700839
• Lead Sponsor: Shanghai 10th People's Hospital

Brief Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder, with a prevalence of 5% to 15% in premenopausal women. Patients with PCOS presents as abnormal menstruation, ovulation disorders and/or hyperandrogenemia, and often accompanied by insulin resistance and other metabolic abnormalities. Metformin has been clarified as an option in patients with PCOS. However, the clinical responses to metformin are limited and different. Sodium glucose co-transporter 2 (SGLT2) inhibitors are novel drugs for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits. Limited data is available on the efficacy of SGLT2 inhibitors in patients with PCOS.

Detailed Description

This clinical study aims to determine the safety and efficacy of canagliflozin vs metformin in Polycystic Ovary Syndrome (PCOS) patients with insulin resistance (IR). Methods: A single center, prospective, randomized open-label study (ratio 1:1), non-inferiority trial was conducted in the department of endocrinology, Shanghai Tenth People's Hospital between July 2019 and April 2021. PCOS women aged 18-45 years with IR were enrolled and randomly assigned to either canagliflozin 100 mg (n = 33) or metformin 1500-2000 mg (n = 35) daily for 12 weeks. The primary outcome was changes in HOMA-IR after 12 weeks treatment. The secondary outcomes included changes in anthropometric, menstrual frequency, sex hormone and metabolic parameters.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-30
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

• Women who are pregnant or have a pregnancy plan within six months; ·Congenital adrenocortical hyperplasia;
• Hyperprolactinemia;
• Hyperthyroidism or hypothyroidism;
• Abnormal liver function (≥ 3 times of the upper limit of normal range);
• Abnormal renal function (GFR<60ml/min/1.73m2);
• Adrenal or ovarian tumors secreting androgens;
• Used contraceptives, metformin, GLP-1RA, SGLT2I, pioglitazone and contraceptives in the last 3 month.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGLT2 inhibitors group	SGLT2 inhibitors	Intervention with SGLT2 inhibitors (100mg/d) for 3 months
Metformin group	Metformin	Intervention with metformin (1500-2000mg/d) for 3 months

Primary Outcome Measures

Name	Time	Method
HOMA-IR	3 months	Homeostatic model assessment insulin resistance index

Secondary Outcome Measures

Name	Time	Method
CR	3 months	Creatinine in umol/L
WC	3 months	Waist Circumference (cm）
HC	3 months	Hip Circumference（cm）
ALT	3 months	alanine aminotransferase in U/L
UA	3 months	Uric acid in umol/L
Menstrual cycles	3 months	annual number of menstrual cycles
FBG	3 months	fasting blood-glucose in mmol/L
AST	3 months	Aspartate aminotransferase in U/L
PBG	3 months	postprandial blood-glucose in mmol/L
LDL-c	3 months	low-density lipoprotein cholesterol in mmol/L
HDL-c	3 months	high-density lipoprotein cholesterol in mmol/L
TC	3 months	Total Cholesterol in mmol/L
TG	3 months	Triglyceride in mmol/L
TT	3 months	total testosterone in nmol/L
FSH	3 months	follicle-stimulating hormone in IU/L）
male pattern baldness	3 months	male pattern baldness
E2	3 months	Estradiol in pmol/L、PRL(Prolactin in uIU/ml)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	3 months	Adverse events and Safety data in two treatment groups.
DHEAS	3 months	Dehydroepiandrosterone Sulfate in ug/dl
AD	3 months	Androstenedione in ng/ml
Metabonomics	3 months	the change of Metabonomics after the treatment
Ferriman-Gallwey score	3 months	Ferriman-Gallwey score、acne, male pattern baldness
FT	3 months	Free testosterone in pg/ml
BMI	3 months	body mass index in kg/m\^2
acne score	3 months	male pattern baldness
HOMA- ISI	3 months	Homeostatic model assessment insulin sensitivity index
LH	3 months	Luteinizing hormone in IU/L
WHR	3 months	Waist/hip Ratio
FINS	3 months	fasting serum insulin in mU/L
PINS	3 months	Postprandial insulin in mU/L
PRL	3 months	Prolactin in uIU/ml
SHBG	3 months	sex hormone binding globulin in nmol/L

Trial Locations

Locations (1)

Shanghai Tenth People' Hospital; 🇨🇳 Shanghai, Shanghai, China