Dapagliflozin Efficacy and Action in PCOS

Phase 3

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Drug: Placebo; Drug: Dapagliflozin

• Registration Number: NCT04213677
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

The purpose of this study is to assess the efficacy and safety of dapagliflozin on improving insulin resistance and hyperandrogenemia in obesity women with polycystic ovary syndrome.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-26
• Study First Posted: 2019-12-30
• Study Start: 2020-03-20
• Primary Completion: 2022-10-01
• Study Completion: 2022-11-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 165

Inclusion Criteria

1. women aged 18 to 45 years;
2. Subjects with PCOS diagnosed by according to the Rotterdam criteria;
3. BMI ≥24 kg/m2 and/ or Homeostatic model assessment of insulin resistance (HOMA-IR) with a cutoff ≥2.5;
4. No pregnancy plan within the next 6 months;

Exclusion Criteria

1. Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary;
2. Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes;
3. Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis;
4. Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month;
5. Taking letrozole, clomiphene, oral contraceptive, glucocorticoid, gonadotropin, gonadotropin releasing hormone agonist, anti-androgen drug (spironolactone, cycloproterenone acetate, Flutamide etc.) and/or other drugs for PCOS in the past three months;
6. History of recurrent urinary tract infection;
7. History of malignant tumor;
8. Currently participating in weight loss programs or weight change in the past 3 months (> 5% current body weight) or have a history of gastrointestinal surgery.
9. Serious liver dysfunction or chronic kidney disease (AST or ALT > 3 times the upper limit of normal, or eGFR<30 ml/min/1.73 m2);
10. Women who are pregnant or plan to become pregnant;
11. Subject is, in the judgment of the Investigator, unlikely to comply with the protocol or has any severe concurrent medical or psychological condition that may affect the interpretation of efficacy or safety data;
12. Participation in other clinical trial in the 4 weeks before randomization;
13. Patients who are unwilling or unable to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo (Participants will receive placebo po qd)
Dapagliflozin	Dapagliflozin	Dapagliflozin (Participants will receive dapagliflozin 10mg po qd).

Primary Outcome Measures

Name	Time	Method
Improvement in insulin resistance over 12 weeks	Baseline and 12 weeks	Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)
Improvement in serum androgen level over 12 weeks	Baseline and 12 weeks	Change in androgen level assessed by free testosterone index(FAI)

Secondary Outcome Measures

Name	Time	Method
Change in serum free testosterone(FT)	Baseline to 12 week
Net change in BMI	Baseline to 12 week
Net change in glucose	Baseline to 12 week
Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)	Baseline to 12 week
Net change in androstenedione(AD) level	Baseline and 12 weeks
Net change in waist circumference	Baseline to 12 week
Net Change in liver fat	Baseline to 12 week	Liver fat will be assessed by liver fibroscan.
Net change in body weight	Baseline to 12 week
Change in serum sex hormone binding globulin(SHBG)	Baseline to 12 week
Net change in total testosterone (TT) level	Baseline and 12 weeks
Net change in dehydroepiandrosterone-sulfate(DHEAS) level	Baseline and 12 weeks
Net change in luteinzing hormone(LH) level	Baseline and 12 weeks
Change in ovulation rate assessed by serum progesterone	Baseline to 12 week

Trial Locations

Locations (1)

Nanfang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China