Diabetes Mellitus, Type 2Phase 2EMPOXNCT02890745
The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
A Phase 2 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Henrik Enghusen Poulsen at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Empagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2016to 22 Jan 2020
- Phase
- Phase 2
- 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 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes
- HbA1c: 6.5-9.0%
- Capable of understanding oral- and written information
- Caucasian
Who cannot join
- Estimated glomerular filtration rate (eGFR) < 60 mL/hour/1.73 m2
- Currently receiving insulin treatment
- Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
- Genital infection within 14 days
- Plasma alanine aminotransferase ≥3 times upper normal limit
- Treatment with sodium glucose cotransporter (SGLT) -2 inhibitor within 2 months
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- Hyperglycaemic symptoms
- Psychiatric disorder
- Intolerance to empagliflozin or other agents relevant to study
- Non-compliant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Empagliflozin, Placebo
- Keywords
- Empagliflozin, Oxidative stress, Oxidative nucleic acid modifications, 8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxo-7,8-dihydroguanosine
- 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.
EmpagliflozinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | One tablet 25 mg empagliflozin every morning for 14 days Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | One tablet placebo every morning for 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
Measured: Change from baseline after fourteen days of intervention
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
Measured: Change from baseline after fourteen days of intervention
Secondary outcomes (2)
Plasma levels of malondialdehyde
Measured: Change from baseline after fourteen days of intervention
Plasma levels of iron, ferritin, transferrin and transferrin saturation
Measured: Measured at baseline and after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startNov 2016
- Primary completion22 Jan 2020
- Study completion22 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henrik Enghusen Poulsen
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, University of Copenhagen
- Responsible party
- Sponsor-investigator, Henrik Enghusen Poulsen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890745
- Sponsor's protocol ID
- 2016-100
- Acronym
- EMPOX
- Status last verified
- Jun 2021
- First submitted
- 31 Aug 2016
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Larsen EL, Andersen A, Kjaer LK, Eickhoff MK, Frimodt-Moller M, Persson F, Rossing P, Lykkesfeldt J, Knop FK, Vilsboll T, Rungby J, Poulsen HE. Effects of two- and twelve-weeks sodium-glucose cotransporter 2 inhibition on DNA and RNA oxidation: two randomized, placebo-controlled trials. Free Radic Res. 2023 Feb;57(2):140-151. doi: 10.1080/10715762.2023.2213820. Epub 2023 May 19.
PubMed 37171199Larsen EL, Cejvanovic V, Kjaer LK, Vilsboll T, Knop FK, Rungby J, Poulsen HE. The effect of empagliflozin on oxidative nucleic acid modifications in patients with type 2 diabetes: protocol for a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2017 May 9;7(5):e014728. doi: 10.1136/bmjopen-2016-014728.
PubMed 28490557
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOX - A Randomised, Double-blinded, Placebo Controlled Study That Evaluates the Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02890745
- Acronym / sponsor ID
- EMPOX / 2016-100
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Empagliflozin, Oxidative stress, Oxidative nucleic acid modifications, 8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxo-7,8-dihydroguanosine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Henrik Enghusen PoulsenUniversity, hospital or other
- Collaborators
- University Hospital, Gentofte, Copenhagen, University of Copenhagen
- Study start
- Nov 2016 (actual)
- Primary completion
- 22 Jan 2020 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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 investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes. The association is examined by comparing the difference in oxidative modifications before and after 14 days treatment with 25 mg empagliflozin compared to placebo treatment. The study is randomised, double-blinded, and placebo controlled. Each treatment group consists of 17 males with type 2 diabetes. Oxidative modifications are measured by urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine and 8-oxo-7,8-dihydroguanosine. A student t-test will be performed to compare the drug treatment with placebo. The results will be published in a peer-review journal.
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 |
|---|---|---|
| Empagliflozin | Experimental | Drug: EmpagliflozinOne tablet 25 mg empagliflozin every morning for 14 days |
| Placebo | Placebo comparator | Drug: PlaceboOne tablet placebo every morning for 14 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with type 2 diabetes
- HbA1c: 6.5-9.0%
- Capable of understanding oral- and written information
- Caucasian
Key exclusion criteria (10 listed)
- Estimated glomerular filtration rate (eGFR) < 60 mL/hour/1.73 m2
- Currently receiving insulin treatment
- Coronary artery bypass grafting, percutaneous coronary intervention, acute coronary syndrome, stroke, lung embolism, deep vein thrombosis, or transitory cerebral ischemia within 6 months
- Genital infection within 14 days
- Plasma alanine aminotransferase ≥3 times upper normal limit
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 |
|---|---|---|
| Empagliflozin | Drug | Empagliflozin |
| Placebo | Drug | Placebo |
Primary outcome
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
Time frame: Change from baseline after fourteen days of intervention
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
Time frame: Change from baseline after fourteen days of intervention
2 secondary outcomes
Plasma levels of malondialdehyde
Time frame: Change from baseline after fourteen days of intervention
Plasma levels of iron, ferritin, transferrin and transferrin saturation
Time frame: Measured at baseline and after intervention
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 10 Jun 2021.
- Derived from this study: PubMed 37171199Larsen EL, Andersen A, Kjaer LK, Eickhoff MK, Frimodt-Moller M, Persson F, Rossing P, Lykkesfeldt J, Knop FK, Vilsboll T, Rungby J, Poulsen HE. Effects of two- and twelve-weeks sodium-glucose cotransporter 2 inhibition on DNA and RNA oxidation: two randomized, placebo-controlled trials. Free Radic Res. 2023 Feb;57(2):140-151. doi: 10.1080/10715762.2023.2213820. Epub 2023 May 19.
- Derived from this study: PubMed 28490557Larsen EL, Cejvanovic V, Kjaer LK, Vilsboll T, Knop FK, Rungby J, Poulsen HE. The effect of empagliflozin on oxidative nucleic acid modifications in patients with type 2 diabetes: protocol for a randomised, double-blinded, placebo-controlled trial. BMJ Open. 2017 May 9;7(5):e014728. doi: 10.1136/bmjopen-2016-014728.
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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 2 study testing Empagliflozin in people with Diabetes Mellitus, Type 2, run by Henrik Enghusen Poulsen at 1 site in Denmark.
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 10 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 10 Jun 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h) (time frame: Change from baseline after fourteen days of intervention). 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?
On the ClinicalTrials.gov record for NCT02890745, which also lists 2 linked publications.
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 10 Jun 2021.