Clinical trial NCT01888796: Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus
Official title: Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2 (T2DM)
Left Ventricular Diastolic Dysfunction
Keywords: T2DM
diastolic dysfunction
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2013-06-28
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in left ventricular diastolic function
timeFrame: baseline and 6 months
Secondary outcomes:
measure: Change in serum NT-pro BNP levels
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Internal Medicine I, University Hospital
Study officials:
affiliation: Department of Internal Medicine I, RWTH Aachen University Hospital
name: Nikolaus Marx, Univ.-Prof.
role: PRINCIPAL_INVESTIGATOR
References: