Polycystic Ovary SyndromePhase 3DEAPNCT04213677
Dapagliflozin Efficacy and Action in PCOS
A Phase 3 study testing Dapagliflozin in people with Polycystic Ovary Syndrome, run by Nanfang Hospital, Southern Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Dapagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteChina
- Study dates
- 20 Mar 2020to 1 Nov 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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;
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
About this study
Official title: Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial
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.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Dapagliflozin, Placebo
- Keywords
- Polycystic Ovary Syndrome, SGLT2 inhibitor
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.
PlaceboDrug
Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin | Experimental | Dapagliflozin (Participants will receive dapagliflozin 10mg po qd). Receives: Drug: Dapagliflozin |
| Placebo | Placebo comparator | Placebo (Participants will receive placebo po qd) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in insulin resistance over 12 weeks
Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)
Measured: Baseline and 12 weeks
Improvement in serum androgen level over 12 weeks
Change in androgen level assessed by free testosterone index(FAI)
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)
Measured: Baseline to 12 week
Change in serum free testosterone(FT)
Measured: Baseline to 12 week
Change in serum sex hormone binding globulin(SHBG)
Measured: Baseline to 12 week
Net change in total testosterone (TT) level
Measured: Baseline and 12 weeks
Net change in dehydroepiandrosterone-sulfate(DHEAS) level
Measured: Baseline and 12 weeks
Net change in androstenedione(AD) level
Measured: Baseline and 12 weeks
Net change in luteinzing hormone(LH) level
Measured: Baseline and 12 weeks
Net change in waist circumference
Measured: Baseline to 12 week
Net Change in liver fat
Liver fat will be assessed by liver fibroscan.
Measured: Baseline to 12 week
Change in ovulation rate assessed by serum progesterone
Measured: Baseline to 12 week
Net change in body weight
Measured: Baseline to 12 week
Net change in BMI
Measured: Baseline to 12 week
Net change in glucose
Measured: Baseline to 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start20 Mar 2020
- Primary completion1 Oct 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huijie Zhang, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213677
- Sponsor's protocol ID
- NFEC-2019-243
- Acronym
- DEAP
- Status last verified
- Jan 2023
- First submitted
- 4 Dec 2019
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dapagliflozin in Polycystic Ovary Syndrome: a Multicentre, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04213677
- Acronym / sponsor ID
- DEAP / NFEC-2019-243
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic Ovary Syndrome, SGLT2 inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 30 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin | Experimental | Drug: DapagliflozinDapagliflozin (Participants will receive dapagliflozin 10mg po qd). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (Participants will receive placebo po qd) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinParticipants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education. | Drug | Dapagliflozin |
| PlaceboParticipants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education. | Drug | Placebo |
Primary outcome
Improvement in insulin resistance over 12 weeks
Time frame: Baseline and 12 weeks
Change in insulin resistance assessed by insulin sensitivity index(HOMA-IR)
Improvement in serum androgen level over 12 weeks
Time frame: Baseline and 12 weeks
Change in androgen level assessed by free testosterone index(FAI)
13 secondary outcomes
Change in AUC (area under a curve) of glucose and insulin during the oral glucose tolerant test (OGTT)
Time frame: Baseline to 12 week
Change in serum free testosterone(FT)
Time frame: Baseline to 12 week
Change in serum sex hormone binding globulin(SHBG)
Time frame: Baseline to 12 week
Net change in total testosterone (TT) level
Time frame: Baseline and 12 weeks
Net change in dehydroepiandrosterone-sulfate(DHEAS) level
Time frame: Baseline and 12 weeks
Net change in androstenedione(AD) level
Time frame: Baseline and 12 weeks
Net change in luteinzing hormone(LH) level
Time frame: Baseline and 12 weeks
Net change in waist circumference
Time frame: Baseline to 12 week
Net Change in liver fat
Time frame: Baseline to 12 week
Change in ovulation rate assessed by serum progesterone
Time frame: Baseline to 12 week
Net change in body weight
Time frame: Baseline to 12 week
Net change in BMI
Time frame: Baseline to 12 week
Net change in glucose
Time frame: Baseline to 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dapagliflozin in people with Polycystic Ovary Syndrome, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in insulin resistance over 12 weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.