Effekt von Linagliptin auf die myokardiale diastolische Dysfunktion in Patienten mit Diabetes mellitus Typ 2

Phase 1

• Conditions: Patients with type 2 diabetes mellitus and diastolic dysfunction; MedDRA version: 17.0Level: HLGTClassification code 10019280Term: Heart failuresSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 17.0Level: PTClassification code 10012601Term: Diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-003858-81-DE
• Lead Sponsor: RWTH Aachen, Medizinische Fakultät

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-04-22
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Diabetes mellitus Type 2
2.Age > 18 years
3.HbA1c > 7%
4.Left ventricular diastolic dysfunction determined by echocardiography as é < 8 in addition to
-E/A < 0.8 (Grade I) or
-E/A 0.8-2 and left atrial volume = 34 ml/m2 (Grade II) or
-E/A = 2 (Grade III)
5.Stable anti-diabetic medication for the last 6 weeks which should include a maximal tolerated dose of metformin (unless contraindication or intolerance to metformin does exist)
6.Indication to increase anti-diabetic medication as judged by the investigator
7.Written informed consent prior to study participation

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Subjects, fulfilling one or more of the following exclusion criteria will not be included in the study:
1.Diabetes mellitus type 1
2.Echocardiography:
-decreased left ventricular systolic function, ejection fraction (EF) <45%
-regional wall motion abnormalities
-Hypertrophic cardiomyopathy (septum >15mm)
-Severe valvular dysfunction
3.Uncontrolled hypertension
4.Paroxysmal atrial fibrillation during the last two months
5.Use of DPP-4 Inhibitor (Dipeptidyyl-peptidase IV Inhibitor), GLP-1 agonists
6.Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis
7.Active malignant disease
8.HbA1c > 10%
9.Recent (<6 weeks) clinically significant coronary or cerebral vascular event, current angina pectoris or ischemia on stress tests
10.Pregnant females as determined by positive [serum or urine] hCG test at Screening or prior to dosing. Participants of child-bearing age should use adequate contraception as defined in the study protocol.
11.Lactating females
12.The subject has a history of any other illness, which, in the opinion of the Investigator, might pose an unacceptable risk by administering study medication.
13.The subject received an investigational drug within 30 days prior to inclusion into this study
14.The subject has any current or past medical condition and/or required medication to treat a condition that could affect the evaluation of the study
15.The subject is unwilling or unable to follow the procedures outlined in the protocol
16.The subject is mentally or legally incapacitated
17. Patients with a history of pancreatitis

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine the effect of Linagliptin 5mg qd versus placebo on diastolic function in patients with type 2 diabetes mellitus and diastolic dysfunction as assessed by transthoracic echocardiography.;Secondary Objective: To examine the effect of Linagliptin 5 mg qd versus placebo on serum levels of NT-pro BNP as a biomarker of heart failure. ;Primary end point(s): -Change in left ventricular diastolic function between baseline and after 6 month as determined by 2D and novel 3D parameter global Strain Rate E<br>-Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrium (LA) volume<br>;Timepoint(s) of evaluation of this end point: after 6 month

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): -Change in serum NT-pro BNP levels;Timepoint(s) of evaluation of this end point: after 6 month