Diabetes Mellitus Type 2 (T2DM), Left Ventricular Diastolic Dysfunction
Conditions
Keywords
T2DM, diastolic dysfunction
Brief summary
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.
Detailed description
Treatment: 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.
Interventions
DRUGplacebo
DRUGLinagliptin
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diabetes mellitus Type 2 2. Age \> 50 years 3. HbA1c \> 7% 4. Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2 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
Exclusion criteria
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. Atrial fibrillation 5. Obstructive sleep apnea syndrome 6. Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione 7. Kidney disease CKD 4 and more (GFR \< 30 ml/min/1.73) 8. Liver disease (ALT or AST \> 3 times the upper limit of norm) or known liver cirrhosis 9. Active malignant disease 10. HbA1c \> 8.5% 11. Recent (\<3 months) clinically significant coronary or cerebral vascular event 12. 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. 13. Lactating females 14. 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. 15. The subject received an investigational drug within 30 days prior to inclusion into this study 16. 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 17. The subject is unwilling or unable to follow the procedures outlined in the protocol 18. The subject is mentally or legally incapacitated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in left ventricular diastolic function | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum NT-pro BNP levels | baseline and 6 months | Change in serum NT-pro BNP levels |
Countries
Germany
Outcome results
None listed