Diastolic Dysfunction in Patients With Type 2 Diabetes Mellitus

Left Ventricular Diastolic Dysfunction Clinical Trial

— Diast Dysfkt  

Official title:

Effect of Linagliptin Therapy on Myocardial Diastolic Function in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01888796
• Other study ID #: 12-025
• Secondary ID: 2012-003858-81EK
• Status: Terminated
• Phase: Phase 3
• First received: June 20, 2013
• Last updated: April 10, 2017
• Start date: September 2013
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 (T2DM)
• Diabetes Mellitus, Type 2
• Left Ventricular Diastolic Dysfunction
• Ventricular Dysfunction, Left

Intervention

Drug:
• Linagliptin

• placebo

Locations

Country	Name	City	State
Germany	Department of Internal Medicine I, University Hospital	Aachen

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in left ventricular diastolic function	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	baseline and 6 months
Secondary	Change in serum NT-pro BNP levels	Change in serum NT-pro BNP levels	baseline and 6 months