Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus (Diast Dysfkt)

RWTH Aachen University

Status and phase: Terminated; Phase 3

Conditions: Left Ventricular Diastolic Dysfunction; Diabetes Mellitus Type 2 (T2DM)

Treatments: Drug: Linagliptin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01888796

12-025

EK 113/13 (Other Identifier)

2012-003858-81 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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8 participants in 2 patient groups, including a placebo group

Linagliptin

Active Comparator group

Description:

Linagliptin 5 mg (tablets) once daily for 6 month

Treatment:

Drug: Linagliptin

Placebo

Placebo Comparator group

Description:

Placebo (tablets) once daily for 6 month

Treatment:

Drug: placebo