Overview

Effects of Linagliptin on Left Ventricular Myocardial DYsfunction in Patients With Type 2 DiAbetes Mellitus and Concentric Left Ventricular Geometry

Status:
Completed
Trial end date:
2019-07-02
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the study is to evaluate the effect of linagliptin 5 mg daily versus the corresponding placebo on the LV systolic function (measured by midwall shortening analysis) in patients with T2DM and a documented baseline concentric LV geometry and LV systolic dysfunction.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Heart Care Foundation
Collaborators:
Fondazione dell'Associazione Medici Diabetologi
Fondazione dell’Associazione Medici Diabetologi
Treatments:
Dipeptidyl-Peptidase IV Inhibitors
Linagliptin
Criteria
Inclusion Criteria:

- Men and women aged equal to or more than 40 years at screening.

- Patients with history of T2DM lasting at least six month prior to the screening visit.

- HbA1c ≤ 8.0% (≤ 64 mmol/mol) at screening.

- Evidence of sinus rhythm at screening ECG evaluation

- No clinical signs/symptoms of a cardiac disease and no evidence of coronary artery
disease on the basis of clinical, electrocardiographic and echocardiographic
evaluation at screening.

- Evidence at baseline echocardiographic examination of concentric left ventricular
geometry, defined as relative wall thickness ≥ 0.42. Relative wall thickness was
calculated as the end-diastolic ratio 2* posterior wall thickness/LV diameter.

- Evidence at baseline echocardiographic examination of LV systolic dysfunction defined
as Midwall shortening (MFS) ≤15%

- Obtained informed consent

Exclusion Criteria:

- Patients with a confirmed indication for an incretin treatment

- Uncontrolled diabetes: HbA1c >8.0% (> 64 mmol/mol) or Fasting Plasma Glucose > 300
mg/dL measured at screening visit.

- Glitazones within the last three months

- Permanent atrial fibrillation

- Uncontrolled hypertension (defined as systolic blood pressure>160 and/or diastolic
blood pressure >90)

- Unstable dosage and changes in type of antihypertensive, lipid lowering and
antidiabetic drugs within 4 weeks before the screening visit.

- Severe chronic renal dysfunction (defined as estimated glomerular filtration rate < 30
ml/min/1.73 m2).

- Previous or current documented history of untreated (by using CPAP) obstructive sleep
apnea syndrome

- Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis.

- Previous or current documented history of malignant disease

- Pregnancy and breast feeding

- Documented alcohol and drug abuse

- Anticipated poor compliance

- Current participation in a clinical trial with other investigational products