NCT02890745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2016

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2020

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

3.2 years

First QC Date

August 31, 2016

Last Update Submit

June 9, 2021

Conditions

Diabetes Mellitus, Type 2

Keywords

EmpagliflozinOxidative stressOxidative nucleic acid modifications8-oxo-7,8-dihydro-2'-deoxyguanosine8-oxo-7,8-dihydroguanosine

Outcome Measures

Primary Outcomes (2)

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

    Change from baseline after fourteen days of intervention

  • Urinary excretion of 8-oxo-7,8-dihydroguanosine (nmol/24h)

    Change from baseline after fourteen days of intervention

Secondary Outcomes (2)

  • Plasma levels of malondialdehyde

    Change from baseline after fourteen days of intervention

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

    Measured at baseline and after intervention

Study Arms (2)

Empagliflozin

EXPERIMENTAL

One tablet 25 mg empagliflozin every morning for 14 days

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

One tablet placebo every morning for 14 days

Drug: Placebo

Interventions

EmpagliflozinDRUG
Empagliflozin
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Diabetes Research, Gentofte Hospital

Hellerup, 2900, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 37171199DERIVED

  • 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.

    PMID: 28490557DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, DMSc, chief physician

Study Record Dates

First Submitted

August 31, 2016

First Posted

September 7, 2016

Study Start

November 1, 2016

Primary Completion

January 22, 2020

Study Completion

January 22, 2020

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

DK(1)