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Dapagliflozin Efficacy and Action in PCOS (DEAP)

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Dapagliflozin

Placebo

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, SGLT2 inhibitor

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary;
Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes;
Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis;
Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month;
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;
History of recurrent urinary tract infection;
History of malignant tumor;
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.
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);
Women who are pregnant or plan to become pregnant;
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;
Participation in other clinical trial in the 4 weeks before randomization;
Patients who are unwilling or unable to give informed consent.

Sites / Locations

Nanfang Hospital of Southern Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dapagliflozin

Placebo

Arm Description

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

Placebo (Participants will receive placebo po qd)

Outcomes

Primary Outcome Measures

Improvement in insulin resistance over 12 weeks

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

Improvement in serum androgen level over 12 weeks

Change in androgen level assessed by free testosterone index(FAI)

Secondary Outcome Measures

Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)

Change in serum free testosterone(FT)

Change in serum sex hormone binding globulin(SHBG)

Net change in total testosterone (TT) level

Net change in dehydroepiandrosterone-sulfate(DHEAS) level

Net change in androstenedione(AD) level

Net change in luteinzing hormone(LH) level

Net change in waist circumference

Net Change in liver fat

Liver fat will be assessed by liver fibroscan.

Change in ovulation rate assessed by serum progesterone

Net change in body weight

Net change in BMI

Net change in glucose

Full Information

NCT ID

NCT04213677

First Posted

December 4, 2019

Last Updated

January 11, 2023

Sponsor

Nanfang Hospital, Southern Medical University

1. Study Identification

Unique Protocol Identification Number

NCT04213677

Brief Title

Dapagliflozin Efficacy and Action in PCOS

Acronym

DEAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

March 20, 2020 (Actual)

Primary Completion Date

October 1, 2022 (Actual)

Study Completion Date

November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

Polycystic Ovary Syndrome, SGLT2 inhibitor

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

165 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dapagliflozin

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (Participants will receive placebo po qd)

Intervention Type

Drug

Intervention Name(s)

Dapagliflozin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in insulin resistance over 12 weeks

Description

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

Time Frame

Baseline and 12 weeks

Title

Improvement in serum androgen level over 12 weeks

Description

Change in androgen level assessed by free testosterone index(FAI)

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)

Time Frame

Baseline to 12 week

Title

Change in serum free testosterone(FT)

Time Frame

Baseline to 12 week

Title

Change in serum sex hormone binding globulin(SHBG)

Time Frame

Baseline to 12 week

Title

Net change in total testosterone (TT) level

Time Frame

Baseline and 12 weeks

Title

Net change in dehydroepiandrosterone-sulfate(DHEAS) level

Time Frame

Baseline and 12 weeks

Title

Net change in androstenedione(AD) level

Time Frame

Baseline and 12 weeks

Title

Net change in luteinzing hormone(LH) level

Time Frame

Baseline and 12 weeks

Title

Net change in waist circumference

Time Frame

Baseline to 12 week

Title

Net Change in liver fat

Description

Liver fat will be assessed by liver fibroscan.

Time Frame

Baseline to 12 week

Title

Change in ovulation rate assessed by serum progesterone

Time Frame

Baseline to 12 week

Title

Net change in body weight

Time Frame

Baseline to 12 week

Title

Net change in BMI

Time Frame

Baseline to 12 week

Title

Net change in glucose

Time Frame

Baseline to 12 week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: women aged 18 to 45 years; Subjects with PCOS diagnosed by according to the Rotterdam criteria; BMI ≥24 kg/m2 and/ or Homeostatic model assessment of insulin resistance (HOMA-IR) with a cutoff ≥2.5; No pregnancy plan within the next 6 months; Exclusion Criteria: Congenital adrenal hyperplasia such as 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, androgen-producing tumors of the adrenal gland or ovary; Other endocrine diseases include poorly controlled thyroid diseases (hyperthyroidism or hypothyroidism), acromegaly, type 2 diabetes; Patients with a history of acute / chronic infection, severe cardio-cerebrovascular diseases and acute / chronic pancreatitis; Taking any antidiabetic medication that would affect insulin resistance or hyperandrogenemia (i.e. TZD, GLP-1RA, DPP-4i, metformin) in the past one month; 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; History of recurrent urinary tract infection; History of malignant tumor; 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. 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); Women who are pregnant or plan to become pregnant; 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; Participation in other clinical trial in the 4 weeks before randomization; Patients who are unwilling or unable to give informed consent.

Facility Information:

Facility Name

Nanfang Hospital of Southern Medical University

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510515

Country

China

12. IPD Sharing Statement

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Dapagliflozin Efficacy and Action in PCOS

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