Clinical study with randomly into groups divided patients (investigational or ineffective control medication), where neither the doctor nor the patient's know the assignment, to determine the effect of the investigational product (Empagliflozin) on the circulation in the smallest vessels of the body.

• Conditions: Type 2 diabetes mellitus; MedDRA version: 17.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-003053-34-DE
• Lead Sponsor: IPPMed – Institut für Pharmakologie und Präventive Medizin GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-19
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
F.1.3.1 Number of subjects for this age range

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)
•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
•History of repetitive urogenital infection per year
•Body mass index > 40 kg/m²
•Triglyceride levels > 1000 mg/dl
•HDL-cholesterol levels < 25 mg/dl
•Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
•History of epilepsia or history of seizures
•Patients being treated for severe auto immune disease e.g. lupus
•Participation in another clinical study within 30 days prior to visit 1
•Individuals at risk for poor protocol or medication compliance
•Subject who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified