Patients with type 2 diabetes mellitus and diastolic dysfunction MedDRA version: 17.0 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders MedDRA version: 17.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Trajenta 5 mg Filmtabletten
Product Name: Trajenta 5 mg coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Linagliptin
CAS Number: 668270-12-0
Other descriptive na
Sponsors
RWTH Aachen, Medizinische Fakultät
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diabetes mellitus Type 2 2. Age > 18 years 3. HbA1c > 7% 4. Left ventricular diastolic dysfunction determined by echocardiography as é =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 -Change in left ventricular diastolic function between baseline and after 6 month as determined by standardized parameter E/é and left atrium (LA) volume ;Timepoint(s) of evaluation of this end point: after 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Change in serum NT-pro BNP levels;Timepoint(s) of evaluation of this end point: after 6 month | — |
Countries
Germany
Contacts
Public ContactClinical Trial Center
Clinical Trial Center Aachen (CTC-A)
Outcome results
None listed