Clinical trial NCT04700839: SGLT2 Inhibitors in Patients With PCOS
Official title: The Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome: A Randomized, Open Label Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome (PCOS);
Insulin resistance (IR)
Sodium-glucose co-transporter-2 inhibitors (SGLT-2i)
Canagliflozin
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 68
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HOMA-IR
timeFrame: 3 months
Secondary outcomes:
measure: WHR
timeFrame: 3 months
measure: WC
timeFrame: 3 months
measure: HC
timeFrame: 3 months
measure: Menstrual cycles
timeFrame: 3 months
measure: FBG
timeFrame: 3 months
measure: PBG
timeFrame: 3 months
measure: FINS
timeFrame: 3 months
measure: PINS
timeFrame: 3 months
measure: ALT
timeFrame: 3 months
measure: AST
timeFrame: 3 months
measure: UA
timeFrame: 3 months
measure: CR
timeFrame: 3 months
measure: LDL-c
timeFrame: 3 months
measure: HDL-c
timeFrame: 3 months
measure: TC
timeFrame: 3 months
measure: TG
timeFrame: 3 months
measure: TT
timeFrame: 3 months
measure: LH
timeFrame: 3 months
measure: FSH
timeFrame: 3 months
measure: E2
timeFrame: 3 months
measure: PRL
timeFrame: 3 months
measure: Metabonomics
timeFrame: 3 months
measure: Ferriman-Gallwey score
timeFrame: 3 months
measure: acne score
timeFrame: 3 months
measure: male pattern baldness
timeFrame: 3 months
measure: HOMA- ISI
timeFrame: 3 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 3 months
measure: BMI
timeFrame: 3 months
measure: SHBG
timeFrame: 3 months
measure: FT
timeFrame: 3 months
measure: DHEAS
timeFrame: 3 months
measure: AD
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People' Hospital
state: Shanghai
Study officials:
affiliation: Shang hai Tenth People's Hospital
name: Shen Qu, Dr
role: STUDY_CHAIR
References:
citation: 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;90(6):805-813. doi: 10.1111/cen.13968. Epub 2019 Apr 2.