Diabetes mellitus MedDRA version: 14.1 Level: LLT Classification code 10012613 Term: Diabetes mellitus non-insulin-dependent System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Trajenta
Product Name: Trajenta
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Linagliptin
CAS Number: 668270-12-0
Other descriptive name: LINAGLIPTIN
Concentration unit: mg
Sponsors
University Hospital Erlangen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of linagliptin compared to placebo on basal production and release of nitric oxide (NO) from renal vasculature, as assessed by changes of renal plasma flow due to L-NMMA infusion. ;Secondary Objective: To determine the effects of linagliptin compared to placebo on - other renal hemodynamic parameters: RPF, GFR and FF, RVR, calculated intraglomerular pressure. - UACR and tubular markers (e.g. NGAL). - markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP). - metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol) To determine the effect of linagliptin compared to baseline on - the change of RPF due to L-NMMA-infusion - other renal hemodynamic parameters: RPF, GFR and FF, RVR, calculated intraglomerular pressure. - UACR and tubular markers (e.g. NGAL). - markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP). - metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol) To determine the relationship between changes of renal endothelial function with metabolic changes and changes of isoprostanes. ;Primary end point(s): Absolute change of L-NMMA on renal plasma flow between placebo and linagliptin.;Timepoint(s) of evaluation of this end point: After 4 weeks treatment with placebo and linagliptin. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - the effects of linagliptin compared to placebo on other renal hemodynamic parameters: Renal plasma flow, glomerular filtration rate and filtration fraction, renal vascular resistance, calculated intraglomerular pressure. - the effect of linagliptin compared to placebo on urinary albumin creatinine ratio and tubular markers (e.g. NGAL). - the effect of linagliptin compared to placebo on markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP). - the effect of linagliptin compared to placebo on metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol) - the effect of linagliptin compared to baseline on the change of renal plasma flow due to L-NMMA-infusion - the effects of linagliptin compared to baseline on other renal hemodynamic parameters: Renal plasma flow, glomerular filtration rate and filtration fraction, renal vascular resistance, calculated intraglomerular pressure. - the effect of linagliptin compared to baseline on urinary albumin creatinine ratio and tubular markers (e.g. NGAL). - the effect of linagliptin compared to baseline on markers of oxidative stress (e.g. isoprostanes) and inflammation (e.g. hsCRP). - the effect of linagliptin compared to baseline on metabolic parameters (fasting glucose, fasting insulin, triglycerides, total-, LDL- and HDL-cholesterol) - the relationship between changes of renal endothelial function with metabolic changes and changes of isoprostanes. ;Timepoint(s) of evaluation of this end point: Baseline and after 4 weeks treatment with linagliptin and placebo | — |
Countries
Germany
Contacts
Public ContactClinical Research Center
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen
Outcome results
None listed