Effect of Empagliflozin on Macrovascular and Microvascular Circulation and on Endothelium Function

NCT02471963 | Completed Phase 3 DMC

• 1 other identifier: CRC2014EMPA
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Empagliflozin may lead to improved vascular and endothelial function in the macro- (pulse wave reflection) and microcirculation (retinal circulation) and improve cardiovascular risk factors, imparticular by effectively controlling hyperglycemia, arterial hypertension and obesity.

Conditions

Diabetes Mellitus Type 2

Keywords

Empagliflozin; Diabetes mellitus; Macro- and Microcirculation; Vascular Improvement; Endothelium function

Outcome Measures

Primary Outcomes (1)

• Effect of empagliflozin after 6 weeks of treatment on macrocirculation

  To analyse the effect of empagliflozin after 6 weeks of treatment on macrocirculation as assessed by the pulse wave reflection in the peripheral arterial tree with the composite parameters: central (aortic) systolic pressure, central (aortic) pulse pressure, augmentation pressure, forward wave amplitude, backward wave amplitude and the ratio of forward and backward (pulse wave velocity) compared to placebo.

  6 weeks

Secondary Outcomes (3)

• Effect of empagliflozin after 6 weeks of treatment on microcirculation

  6 weeks

• Endothelium Function

  6 weeks

• Biomarkers

  6 weeks

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

Empagliflozin, 25 mg/day, oral administration, 6 weeks

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

Placebo, oral administration, 6 weeks

Drug: Placebo

Interventions

Empagliflozin DRUG

Also known as: Jardiance

Empagliflozin

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus defined by fasting glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or on blood glucose lowering medication
• Age of 18 - 75 years
• Male and Female patients (females of child bearing potential must be using adequate contraceptive precautions)
• Females of childbearing potential or within two years of the menopause must have a negative urine pregnancy test at screening visit
• Informed consent (§ 40 Abs. 1 Satz 3 Punkt 3 AMG) has to be given in written form.

You may not qualify if:

• Any other form of diabetes mellitus than type 2 diabetes mellitus
• Use of insulin, glitazone, gliptine or SGLT-2 inhibitor within the past 3 months
• Patients with more than one oral blood glucose lowering medication
• Any other oral antidiabetic drug that cannot be discontinued for the study period
• HbA1c ≥ 10%
• Fasting plasma glucose \> 240 mg/dl
• UACR ≥ 300 mg/g (early morning spot urine)
• eGFR \< 60 ml/min/1.73m²
• Uncontrolled arterial hypertension (RR ≥ 180/110 mmHg)
• Congestive heart failure (CHF) NYHA stage III and IV
• Severe disorders of the gastrointestinal tract or other diseases which interfere the pharmacodynamics and pharmakinetics of study drugs
• Significant laboratory abnormalities such as SGOT or SGPT levels more than 3 x above the upper limit of normal range
• Drug or alcohol abusus
• Pregnant or breast-feeding patients
• Use of loop diuretics

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

University of Erlangen-Nuremberg

Erlangen, Bavaria, 91054, Germany

Location

Related Publications (5)

• Striepe K, Jumar A, Ott C, Karg MV, Schneider MP, Kannenkeril D, Schmieder RE. Effects of the Selective Sodium-Glucose Cotransporter 2 Inhibitor Empagliflozin on Vascular Function and Central Hemodynamics in Patients With Type 2 Diabetes Mellitus. Circulation. 2017 Sep 19;136(12):1167-1169. doi: 10.1161/CIRCULATIONAHA.117.029529. No abstract available.

  PMID: 28923906 RESULT

• 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: 37268640 DERIVED

• 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: 34991562 DERIVED

• Bosch A, Ott C, Jung S, Striepe K, Karg MV, Kannenkeril D, Dienemann T, Schmieder RE. How does empagliflozin improve arterial stiffness in patients with type 2 diabetes mellitus? Sub analysis of a clinical trial. Cardiovasc Diabetol. 2019 Mar 29;18(1):44. doi: 10.1186/s12933-019-0839-8.

  PMID: 30922297 DERIVED

• 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: 30231923 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Roland E 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. med. Roland E. Schmieder

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: June 15, 2015
• Study Start: December 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: May 15, 2018

Record last verified: 2018-05

Locations

DE (1)