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The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes (EMPOX)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Empagliflozin
Placebo
Sponsored by
Henrik Enghusen Poulsen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Empagliflozin, Oxidative stress, Oxidative nucleic acid modifications, 8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxo-7,8-dihydroguanosine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with type 2 diabetes
  • HbA1c: 6.5-9.0%
  • Capable of understanding oral- and written information
  • Caucasian

Exclusion Criteria:

  • 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
  • Hyperglycaemic symptoms
  • Psychiatric disorder
  • Intolerance to empagliflozin or other agents relevant to study
  • Non-compliant

Sites / Locations

  • Center for Diabetes Research, Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Empagliflozin

Placebo

Arm Description

One tablet 25 mg empagliflozin every morning for 14 days

One tablet placebo every morning for 14 days

Outcomes

Primary Outcome Measures

Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)

Secondary Outcome Measures

Plasma levels of malondialdehyde
Plasma levels of iron, ferritin, transferrin and transferrin saturation

Full Information

First Posted
August 31, 2016
Last Updated
June 9, 2021
Sponsor
Henrik Enghusen Poulsen
Collaborators
University Hospital, Gentofte, Copenhagen, University of Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT02890745
Brief Title
The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes
Acronym
EMPOX
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
January 22, 2020 (Actual)
Study Completion Date
January 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Henrik Enghusen Poulsen
Collaborators
University Hospital, Gentofte, Copenhagen, University of Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Empagliflozin, Oxidative stress, Oxidative nucleic acid modifications, 8-oxo-7,8-dihydro-2'-deoxyguanosine, 8-oxo-7,8-dihydroguanosine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Empagliflozin
Arm Type
Experimental
Arm Description
One tablet 25 mg empagliflozin every morning for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
One tablet placebo every morning for 14 days
Intervention Type
Drug
Intervention Name(s)
Empagliflozin
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Urinary excretion of 8-oxo-7,8-dihydro-2'-deoxyguanosine (nmol/24h)
Time Frame
Change from baseline after fourteen days of intervention
Title
Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)
Time Frame
Change from baseline after fourteen days of intervention
Secondary Outcome Measure Information:
Title
Plasma levels of malondialdehyde
Time Frame
Change from baseline after fourteen days of intervention
Title
Plasma levels of iron, ferritin, transferrin and transferrin saturation
Time Frame
Measured at baseline and after intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with type 2 diabetes HbA1c: 6.5-9.0% Capable of understanding oral- and written information Caucasian Exclusion Criteria: 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 Hyperglycaemic symptoms Psychiatric disorder Intolerance to empagliflozin or other agents relevant to study Non-compliant
Facility Information:
Facility Name
Center for Diabetes Research, Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28490557
Citation
Larsen 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.
Results Reference
derived

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The Effect Effect of Empagliflozin on Oxidative Stress in Patients With Type 2 Diabetes

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