Type 2 DiabetesPhase 4NCT02235298
Dapagliflozin Effects on Epicardial Fat
A Phase 4 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Dapagliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 10 Sep 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Type 2 diabetes, as defined by ADA criteria
- HbA1c < 8% measured at least 1 week prior to the study
- BMI ≥27 kg/m2
- Pre-treatment with Metformin as monotherapy
- Age > 18 and < 65 years old
- Normal and stable hemodynamic status
Who cannot join
- Known contra-indications to Farxiga, in accordance with risks and safety information included in the latest updated Prescribing Information
- Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- Insulin dependent or treated type 2 diabetes
- Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors
- Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
- Signs or symptoms of hypovolemia
Show all 18Show fewer
- Patients with poor glycemic control (HbA1c ≥ 8%) will be excluded to maximize long-term patient retention without need
- History of diabetes ketoacidosis
- Patients with active bladder cancer or with a prior history of bladder cancer
- Acute or chronic infective, including genital mycotic infections
- Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure
- Clinical or laboratory evidences of chronic active liver diseases
- Acute or chronic infective diseases
- Cancer or chemotherapy
- Current use of systemic corticosteroids or in the 3 months prior this study
- Known or suspected allergy to Dapagliflozin, excipients, or related products
- Pregnant, breast-feeding or the intention of becoming pregnant
- Females of childbearing potential who are not using adequate contraceptive methods
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
The purpose of this research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
- Conditions
- Type 2 Diabetes
- Being tested
- Dapagliflozin, Metformin, Placebo
- Keywords
- epicardial fat, diabetes, dapagliflozin
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Farxiga
5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.
MetforminDrug
500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
PlaceboDrug
Placebo pill taken once daily to mimic Dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin and Metformin Group | Experimental | Participants in this group will receive Dapagliflozin in addition to Metformin for 6 months. Receives: Drug: Dapagliflozin; Drug: Metformin |
| Metformin and Placebo Group | Active comparator | Participants in this group will receive Metformin and Placebo for 6 months. Receives: Drug: Metformin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicardial Fat Thickness
Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks
Measured: At Baseline, 12 weeks, 24 weeks
Secondary outcomes (1)
Left Ventricular Mass (LVM)
LVM will be measured in g/m^2 by treating physician using echocardiography at baseline, Week 12 and Week 24
Measured: At Baseline, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study startSep 2015
- Primary completion10 Sep 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Gianluca Iacobellis, University of Miami
- Investigators
- Gianluca Iacobellis, MD, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235298
- Sponsor's protocol ID
- 20140671
- Status last verified
- Jan 2021
- First submitted
- 4 Sep 2014
- Last updated
- 16 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dapagliflozin on Epicardial Fat in Subjects With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02235298
- Acronym / sponsor ID
- 20140671
- Conditions
- Type 2 Diabetes
- Keywords
- epicardial fat, diabetes, dapagliflozin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2015 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- 10 Sep 2020 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 16 Feb 2021
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 research study is to learn about the effect of Dapagliflozin (Farxiga) on the fat of the heart.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin and Metformin Group | Experimental | Drug: Dapagliflozin, Drug: MetforminParticipants in this group will receive Dapagliflozin in addition to Metformin for 6 months. |
| Metformin and Placebo Group | Active comparator | Drug: Metformin, Drug: PlaceboParticipants in this group will receive Metformin and Placebo for 6 months. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Type 2 diabetes, as defined by ADA criteria
- HbA1c < 8% measured at least 1 week prior to the study
- BMI ≥27 kg/m2
- Pre-treatment with Metformin as monotherapy
- Age > 18 and < 65 years old
Key exclusion criteria (18 listed)
- Known contra-indications to Farxiga, in accordance with risks and safety information included in the latest updated Prescribing Information
- Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria
- Insulin dependent or treated type 2 diabetes
- Current use of other SGLT2 inhibitors, Glucagon Like Peptide -1 (GLP- 1) analogs or Dipeptidyl Peptidase 4 (DPP4) inhibitors
- Glomerular Filtration Rate (GFR) < 60 mL/min/1.73 m2
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 |
|---|---|---|
| DapagliflozinAlso: Farxiga5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily. | Drug | Dapagliflozin and Metformin Group |
| Metformin500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL | Drug | Dapagliflozin and Metformin Group, Metformin and Placebo Group |
| PlaceboPlacebo pill taken once daily to mimic Dapagliflozin | Drug | Metformin and Placebo Group |
Primary outcome
Epicardial Fat Thickness
Time frame: At Baseline, 12 weeks, 24 weeks
Epicardial fat thickness will be measured in millimeters by treating physician using echocardiography at Baseline, 12 weeks, 24 weeks
1 secondary outcome
Left Ventricular Mass (LVM)
Time frame: At Baseline, Week 12 and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Gianluca Iacobellis, MD, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin and Metformin in people with Type 2 Diabetes, run by University of Miami at 1 site in United States.
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 6 inclusion and 18 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 16 Feb 2021. 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 United States. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Epicardial Fat Thickness (time frame: At Baseline, 12 weeks, 24 weeks). 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 16 Feb 2021.