EUCTR2014-003053-34-DE
Active, not recruiting
Not Applicable
Randomized, double-blind, placebo controlled, crossover clinical study to analyse the effect of empagliflozin on microvascular circulation - Impact of Empagliflozin on microvascular circulation
ConditionsType 2 diabetes mellitusMedDRA version: 17.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
DrugsJardiance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 diabetes mellitus
- Sponsor
- IPPMed – Institut für Pharmakologie und Präventive Medizin GmbH
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •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
- •Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
- •UACR \= 300 mg/g (early morning spot urine)
- •eGFR \< 60 ml/min/1\.73m²
- •Uncontrolled arterial hypertension (RR \= 180/110 mmHg)
Outcomes
Primary Outcomes
Not specified
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