Effects of Linagliptin on Renal Endothelium Function in Patients with Type 2 Diabetes.

• Conditions: Diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10012613Term: Diabetes mellitus non-insulin-dependentSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-002278-30-DE
• Lead Sponsor: niversity Hospital Erlangen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-14
• Last Update Posted: 17 February 2014

Recruitment & Eligibility

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

Inclusion Criteria

• Age between 18 and 70 years
• Type 2 diabetes without diabetic nephropathy (definition see exclusion criteria)
• Male and Female patients are eligible. Females of child bearing potential or within two years of the menopause are only eligible if pregnancy test at the screening visit is negative and they use adequate contraceptive precautions during the trial.

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
• Patients with more than on one blood glucose lowering medication or on one antidiabetic drug that can not be discontinued for the study period.
• Use of insulin, glitazone or gliptine within the past 3 months
• Any history of stroke, transient ischemic attack, instable angina pectoris, or myocardial infarction within the last 6 months prior to study inclusion
• Urinary albumin excretion (UACR) > 100 mg/g (early morning spot urine)
• eGFR <45 ml/min/1.73m² (MDRD Formula)
• Uncontrolled arterial hypertension (RR =180/ =110mmHg)
• HbA1c = 10%
• Fasting plasma glucose = 240 mg/dl
• Body mass index = 40 kg/m²
• Triglyceride levels = 1000 mg/dl
• HDL-cholesterol levels <25 mg/dl
• Overt congestive heart failure (CHF) or history of CHF
• 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, serum creatinine > 2mg/dl
• Drug or alcohol abusus
• Pregnant or breast-feeding patients
• Any patient currently receiving chronic (>30 consecutive days) treatment with an oral corticosteroid
• 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