Effects of linagliptin on left ventricular myocardial DYsfunction in patients with type 2 DiAbetes mellitus.

Phase 1

• Conditions: Type 2 Diabetes mellitus; MedDRA version: 17.1Level: HLGTClassification code 10018424Term: Glucose metabolism disorders (incl diabetes mellitus)System Organ Class: 10014698 - Endocrine disorders; MedDRA version: 17.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 17.1Level: SOCClassification code 10027433Term: Metabolism and nutrition disordersSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 17.1Level: HLTClassification code 10012602Term: Diabetes mellitus (incl subtypes)System Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2014-004683-38-IT
• Lead Sponsor: Fondazione per il Tuo cuore onlus-ANMCO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-03
• Last Update Posted: 23 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 186

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 130
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified