SGLT2 Inhibitors in Patients With PCOS

Polycystic Ovary Syndrome Clinical Trial

— PCOS  

Official title:

The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04700839
• Other study ID #: SGLT2i PCOS
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: September 2022
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: April 30, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion criteria:

• Fmale aged 18- 45;

• Meet Rotterdam criteria;

• Insulin Rsistance

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• SGLT2 inhibitors
Sodium-glucose cotransporters inhibitors (SGLT2i) are novel hypoglycemic drugs with unique hypoglycemic mechanisms, which are completely independent of islet ß-cell function or insulin sensitivity. Previous studies have shown that SGLT2i may improve IR by inhibiting glucotoxicity, reducing body weight, reducing inflammation, improving islet ß-cell function, and reducing oxidative stress.
• Metformin
Metformin is a classic drug for the treatment of polycystic ovary syndrome, which can improve the degree of insulin resistance in PCOS patients.

Locations

Country	Name	City	State
China	Shanghai Tenth People' Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

Javed Z, Papageorgiou M, Deshmukh H, Rigby AS, Qamar U, Abbas J, Khan AY, Kilpatrick ES, Atkin SL, Sathyapalan T. Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: A randomized controlled study. Clin Endocrinol (Oxf). 2019 Jun — View Citation

Outcome

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

External Links

•   Effects of empagliflozin on metabolic parameters in polycystic ovary syndrome: a randomized controlled study
•   Efficacy of canagliflozin versus metformin in women with polycystic ovary syndrome: A randomized, open-label, noninferiority trial