Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus (Diast Dysfkt)
|ClinicalTrials.gov Identifier: NCT01888796|
Recruitment Status : Terminated (bad recruitment of suitable participants, just 8 patients in one year)
First Posted : June 28, 2013
Last Update Posted : April 12, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Type 2 (T2DM) Left Ventricular Diastolic Dysfunction||Drug: Linagliptin Drug: placebo||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
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
- Change in left ventricular diastolic function [ Time Frame: baseline and 6 months ]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 ]Change in serum NT-pro BNP levels
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888796
|Department of Internal Medicine I, University Hospital|
|Aachen, Germany, 52074|
|Principal Investigator:||Nikolaus Marx, Univ.-Prof.||Department of Internal Medicine I, RWTH Aachen University Hospital|