Diabetes Mellitus, Type 2Phase 4NCT02981966
Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects
A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to 31 May 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25-35 kg/m^2
- Normal Glucose Tolerance subjects (24)
- Type 2 Diabetic Subjects (24)
- Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
- Diabetic subjects must have HbA1c <8.0%
- Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
- Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.
Who cannot join
- Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
- Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center
San Antonio, Texas, 78229
About this study
Official title: Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
Read the detailed description
Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Dapagliflozin, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Farxiga
dapagliflozin, 10mg tablet
PlaceboDrug
Placebo for dapagliflozin
| Study group | Role | What they receive |
|---|---|---|
| T2DM individuals on Dapagliflozin | Active comparator | Individuals with type 2 diabetes mellitus - dapagliflozin Receives: Drug: Dapagliflozin |
| T2DM individuals on Placebo | Placebo comparator | Individuals with type 2 diabetes mellitus on placebo Receives: Drug: Placebo |
| Normal Glucose Tolerance (NGT) on Dapagliflozin | Active comparator | Individuals with normal glucose tolerance - dapagliflozin Receives: Drug: Dapagliflozin |
| Normal Glucose Tolerance (NGT) Placebo | Placebo comparator | Individuals with normal glucose tolerance - on placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous Glucose Production Measurement
Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.
Measured: 3 weeks
Secondary outcomes (1)
Renal Glucose Production Measurement of Change
Renal Glucose Production in T2DM and NGT subjects before and after dapagliflozin/placebo administration from baseline to 240 minutes.
Measured: Baseline to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2016 (estimated)
- Study start23 May 2019
- Primary completion30 Apr 2022
- Study completion31 May 2023
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Eugenio Cersosimo, MD,PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02981966
- Sponsor's protocol ID
- HSC20160596H
- Status last verified
- Feb 2024
- First submitted
- 30 Nov 2016
- Last updated
- 4 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)
- ClinicalTrials.gov ID
- NCT02981966
- Acronym / sponsor ID
- HSC20160596H
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 23 May 2019 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 5 Dec 2016 (estimated)
- Results
- Posted 6 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
Detailed description
Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| T2DM individuals on Dapagliflozin | Active comparator | Drug: DapagliflozinIndividuals with type 2 diabetes mellitus - dapagliflozin |
| T2DM individuals on Placebo | Placebo comparator | Drug: PlaceboIndividuals with type 2 diabetes mellitus on placebo |
| Normal Glucose Tolerance (NGT) on Dapagliflozin | Active comparator | Drug: DapagliflozinIndividuals with normal glucose tolerance - dapagliflozin |
| Normal Glucose Tolerance (NGT) Placebo | Placebo comparator | Drug: PlaceboIndividuals with normal glucose tolerance - on placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 25-35 kg/m^2
- Normal Glucose Tolerance subjects (24)
- Type 2 Diabetic Subjects (24)
- Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
- Diabetic subjects must have HbA1c <8.0%
Key exclusion criteria (2 listed)
- Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
- Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.
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: Farxigadapagliflozin, 10mg tablet | Drug | Normal Glucose Tolerance (NGT) on Dapagliflozin, T2DM individuals on Dapagliflozin |
| PlaceboPlacebo for dapagliflozin | Drug | Normal Glucose Tolerance (NGT) Placebo, T2DM individuals on Placebo |
Primary outcome
Endogenous Glucose Production Measurement
Time frame: 3 weeks
Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.
1 secondary outcome
Renal Glucose Production Measurement of Change
Time frame: Baseline to 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- 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.
Eugenio Cersosimo, MD,PhD principal investigator
The University of Texas Health Science Center at San Antonio
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 in people with Diabetes Mellitus, Type 2, run by The University of Texas Health Science Center at San Antonio 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 7 inclusion and 2 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 4 Mar 2024. 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. 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 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 6 Jun 2023). 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?
Endogenous Glucose Production Measurement (time frame: 3 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 4 Mar 2024.