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