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

R

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

Diabetes mellitus Type 2 Age > 50 years HbA1c > 7% Left ventricular diastolic dysfunction determined by echocardiography as average E/é ≥13 or average E/é≥8 and LA volume ≥34ml/m2 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). Indication to increase anti-diabetic medication as judged by the investigator Written informed consent prior to study participation

Exclusion criteria

Diabetes mellitus type 1 Echocardiography: decreased left ventricular systolic function, ejection fraction (EF) <45% regional wall motion abnormalities hypertrophic cardiomyopathy (septum >15mm) severe valvular dysfunction Uncontrolled hypertension Atrial fibrillation Obstructive sleep apnea syndrome Use of DPP-4 Inhibitor (Dipeptidyl-peptidase IV Inhibitor), GLP 1 agonists, Thiazolindinedione Kidney disease CKD 4 and more (GFR < 30 ml/min/1.73) Liver disease (ALT or AST > 3 times the upper limit of norm) or known liver cirrhosis Active malignant disease HbA1c > 8.5% Recent (<3 months) clinically significant coronary or cerebral vascular event 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. Lactating females 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. The subject received an investigational drug within 30 days prior to inclusion into this study 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 The subject is unwilling or unable to follow the procedures outlined in the protocol The subject is mentally or legally incapacitated

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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