DEAP: Dapagliflozin Efficacy and Action in PCOS

Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04213677
Collaborator
(none)
165
1
2
24.4
6.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
165 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial
Actual Study Start Date :
Mar 20, 2020
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dapagliflozin

Dapagliflozin (Participants will receive dapagliflozin 10mg po qd).

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

Placebo Comparator: Placebo

Placebo (Participants will receive placebo po qd)

Drug: Placebo
Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.

Outcome Measures

Primary Outcome Measures

  1. Improvement in insulin resistance over 12 weeks [Baseline and 12 weeks]

    Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)

  2. 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

  1. Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT) [Baseline to 12 week]

  2. Change in serum free testosterone(FT) [Baseline to 12 week]

  3. Change in serum sex hormone binding globulin(SHBG) [Baseline to 12 week]

  4. Net change in total testosterone (TT) level [Baseline and 12 weeks]

  5. Net change in dehydroepiandrosterone-sulfate(DHEAS) level [Baseline and 12 weeks]

  6. Net change in androstenedione(AD) level [Baseline and 12 weeks]

    sulfate(DHEAS), luteinzing hormone(LH), androstenedione(AD)

  7. Net change in luteinzing hormone(LH) level [Baseline and 12 weeks]

  8. Net change in waist circumference [Baseline to 12 week]

  9. Net Change in liver fat [Baseline to 12 week]

    Liver fat will be assessed by liver fibroscan.

  10. Change in ovulation rate assessed by serum progesterone [Baseline to 12 week]

  11. Net change in body weight [Baseline to 12 week]

  12. Net change in BMI [Baseline to 12 week]

  13. Net change in glucose [Baseline to 12 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanfang Hospital of Southern Medical University Guangzhou Guangdong China 510515

Sponsors and Collaborators

  • Nanfang Hospital of Southern Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huijie Zhang, Professor, Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT04213677
Other Study ID Numbers:
  • NFEC-2019-243
First Posted:
Dec 30, 2019
Last Update Posted:
Feb 22, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Huijie Zhang, Professor, Nanfang Hospital of Southern Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 22, 2022