NCT02383238

Brief Summary

Dapagliflozin leads to improved vascular function in the micro- and macrocirculation by action on various cardiovascular risk factors, in particular by effectively controlling hyperglycemia, arterial hypertension and reducing whole sodium content amongst others.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at below P25 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2014

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

Study Start

First participant enrolled

March 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 24, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

May 11, 2018

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

July 24, 2014

Last Update Submit

May 9, 2018

Conditions

Diabetes Mellitus Type 2

Keywords

Dapagliflozindiabetes mellitusvascular

Outcome Measures

Primary Outcomes (1)

  • Microcirculation

    To analyse the effects after 6 weeks of treatment with dapagliflozin on retinal capillary flow (given as AU) as the key measurement of vascular remodeling in the microcirculation compared to placebo.

    6 weeks

Secondary Outcomes (1)

  • Macrovascular circulation

    6 weeks

Study Arms (2)

Dapagliflozin

ACTIVE COMPARATOR

Dapagliflozin, 10 mg/day, oral administration, 6 weeks

Drug: Dapagliflozin

Placebo

PLACEBO COMPARATOR

Placebo, oral administration, 6 weeks

Drug: Placebo

Interventions

DapagliflozinDRUG

10 mg, oral for 6 weeks

Also known as: Forxiga
Dapagliflozin
PlaceboDRUG

oral for 6 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • HbA1c \> 6.5%
  • age \> 18 years
  • male and females

You may not qualify if:

  • age \> 75 years
  • HbA1c \> 10 %,
  • reduced renal function (eGFR \< 60 ml/min/1.73 m²).
  • insulin therapy, or any antidiabetic medication other than metformin.
  • uncontrolled hypertension (\> 180/\>110 mmHg)
  • cardiovascular event within the last 3 months
  • Use of loop diuretics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Erlangen-Nuernberg

Erlangen, 91054, Germany

Location

Related Publications (6)

  • Karg MV, Bosch A, Kannenkeril D, Striepe K, Ott C, Schneider MP, Boemke-Zelch F, Linz P, Nagel AM, Titze J, Uder M, Schmieder RE. SGLT-2-inhibition with dapagliflozin reduces tissue sodium content: a randomised controlled trial. Cardiovasc Diabetol. 2018 Jan 4;17(1):5. doi: 10.1186/s12933-017-0654-z.

    PMID: 29301520RESULT

  • Staef M, Ott C, Kannenkeril D, Striepe K, Schiffer M, Schmieder RE, Bosch A. Determinants of arterial stiffness in patients with type 2 diabetes mellitus: a cross sectional analysis. Sci Rep. 2023 Jun 2;13(1):8944. doi: 10.1038/s41598-023-35589-4.

    PMID: 37268640DERIVED

  • Gessner A, Gemeinhardt A, Bosch A, Kannenkeril D, Staerk C, Mayr A, Fromm MF, Schmieder RE, Maas R. Effects of treatment with SGLT-2 inhibitors on arginine-related cardiovascular and renal biomarkers. Cardiovasc Diabetol. 2022 Jan 6;21(1):4. doi: 10.1186/s12933-021-01436-x.

    PMID: 34991562DERIVED

  • Kannenkeril D, Jung S, Harazny J, Striepe K, Ott C, Dahlmann A, Kopp C, Schiffer M, Linz P, Nagel AM, Uder M, Schmieder RE. Tissue sodium content correlates with hypertrophic vascular remodeling in type 2 diabetes. J Diabetes Complications. 2021 Dec;35(12):108055. doi: 10.1016/j.jdiacomp.2021.108055. Epub 2021 Sep 29.

    PMID: 34620556DERIVED

  • Kannenkeril D, Bosch A, Harazny J, Karg M, Jung S, Ott C, Schmieder RE. Early vascular parameters in the micro- and macrocirculation in type 2 diabetes. Cardiovasc Diabetol. 2018 Sep 19;17(1):128. doi: 10.1186/s12933-018-0770-4.

    PMID: 30231923DERIVED

  • Ott C, Jumar A, Striepe K, Friedrich S, Karg MV, Bramlage P, Schmieder RE. A randomised study of the impact of the SGLT2 inhibitor dapagliflozin on microvascular and macrovascular circulation. Cardiovasc Diabetol. 2017 Feb 23;16(1):26. doi: 10.1186/s12933-017-0510-1.

    PMID: 28231831DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Roland Schmieder, Prof.

    Department of Medicine 4, University of Erlangen-Nuernberg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Roland E. Schmieder

Study Record Dates

First Submitted

July 24, 2014

First Posted

March 9, 2015

Study Start

March 1, 2014

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

May 11, 2018

Record last verified: 2018-05

Locations

DE(1)