Dapagliflozin Efficacy and Action in PCOS

Polycystic Ovary Syndrome Clinical Trial

— DEAP  

Official title:

Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04213677
• Other study ID #: NFEC-2019-243
• Status: Completed
• Phase: Phase 3
• Start date: March 20, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: January 2023
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Dapagliflozin
Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.
• Placebo
Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Locations

Country	Name	City	State
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in insulin resistance over 12 weeks	Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)	Baseline and 12 weeks
Primary	Improvement in serum androgen level over 12 weeks	Change in androgen level assessed by free testosterone index(FAI)	Baseline and 12 weeks
Secondary	Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)		Baseline to 12 week
Secondary	Change in serum free testosterone(FT)		Baseline to 12 week
Secondary	Change in serum sex hormone binding globulin(SHBG)		Baseline to 12 week
Secondary	Net change in total testosterone (TT) level		Baseline and 12 weeks
Secondary	Net change in dehydroepiandrosterone-sulfate(DHEAS) level		Baseline and 12 weeks
Secondary	Net change in androstenedione(AD) level		Baseline and 12 weeks
Secondary	Net change in luteinzing hormone(LH) level		Baseline and 12 weeks
Secondary	Net change in waist circumference		Baseline to 12 week
Secondary	Net Change in liver fat	Liver fat will be assessed by liver fibroscan.	Baseline to 12 week
Secondary	Change in ovulation rate assessed by serum progesterone		Baseline to 12 week
Secondary	Net change in body weight		Baseline to 12 week
Secondary	Net change in BMI		Baseline to 12 week
Secondary	Net change in glucose		Baseline to 12 week