Diastolic Dysfunction (Diast Dysfkt)
Examination of the effect of Linagliptin versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography.
Furthermore the effect on serum levels of NT-pro BNP as a biomarker of heart failure will be investigated.
Diabetes Mellitus Type 2 (T2DM),
Left Ventricular Diastolic Dysfunction
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus|
- Change in left ventricular diastolic function [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Change in left ventricular diastolic function between baseline and after 6 month as determined by 2D and novel 3D parameter global Strain Rate E Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrial (LA) volume
- Change in serum NT-pro BNP levels [ Time Frame: baseline and 6 months ] [ Designated as safety issue: No ]Change in serum NT-pro BNP levels
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Linagliptin
Linagliptin 5 mg (tablets) once daily for 6 month
Other Name: Trade name Trajenta® by Boehringer Ingelheim (BI) Pharma GmbH & Co KG, Biberach, Germany
Placebo Comparator: Placebo
Placebo (tablets) once daily for 6 month
The Patients will receive Linagliptin 5 mg QD or placebo for a period of 6 months.
The echocardiography and 24h RR measurement will be performed at baseline and 6 months after initiation of the therapy.
The blood chemistry (Glucose, HbA1c, BNP) will be evaluated at baseline as well as 3 and 6 months after initiation of the therapy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01888796
|Contact: Nikolaus Marx, Univ.-Prof.||+49 241 80 firstname.lastname@example.org|
|Contact: Michael Lehrke, PD Dr. med.||+49 241 email@example.com|
|Department of Internal Medicine I, University Hospital||Recruiting|
|Aachen, Germany, 52074|
|Contact: Nikolaus Marx, Univ.-Prof. +49 241 80 89301 firstname.lastname@example.org|
|Contact: Angela Sudhoff, M.Sc. +49 241 80 37429 email@example.com|
|Principal Investigator:||Nikolaus Marx, Univ.-Prof.||Department of Internal Medicine I, RWTH Aachen University Hospital|