Type 2 Diabetes
Conditions
Interventions
Trade Name: Galvus
Product Name: vildagliptin
Product Code: LAF237
Pharmaceutical Form: Tablet
INN or Proposed INN: vildagliptin
CAS Number: 274901-16-5
Current Sponsor code: LAF237A
Concentration uni
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must give written informed consent before any assessment is performed. 2. Patients 18-85 years old (inclusive) at Visit 1. 3. Patients with T2DM, diagnosed at least 3 months prior to Visit 1, either untreated (defined as not taking anti-diabetic therapy for at least 8 weeks prior to Visit 1) or treated with anti-diabetic therapy (defined as sulfonylurea, insulin, alpha-glucosidase inhibitors, or glinides as monotherapy or combination therapy for at least 8 weeks prior to Visit 1) and maintaining dietary advice and exercise habits during the full course of the study. 4. Stable dose of anti-diabetic therapy over the past 4 weeks prior to Visit 1 (stable insulin therapy is defined as ± 20% of total daily units) for patients on anti-diabetic treatment. 5. CHF (NYHA Class I, Class II, or Class III) at Visit 1. • Treatment of heart failure should be according to local/national guidelines; beta-blockers are allowed unless specifically contraindicated. 6. LVEF =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Fasting Plasma Glucose (FPG) = 270 mg/dL (15 mmol/L) at Visit 1. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL). 3. A history of: • type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes, e.g. Cushing’s syndrome and acromegaly. • acute metabolic diabetic complications such as ketoacidosis or hyperosmolar state (coma) within the past 6 months. 4. Patients that have been enrolled in a vildagliptin clinical trial or taken other DPP-4 inhibitor, GLP-1 mimetics (e.g. exenatide), GLP-1 analogues (e.g. liraglutide) studies within 6 months prior to visit 1. 5. Patients taking vildagliptin at any time. 6. Patients taking thiazolidinediones (TZDs). TZDs given up to 12 months prior to Visit 1 are allowed. 7. Acute infections which may affect blood glucose control within 4 weeks prior to visit 1 and other concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study 8. Any of the following within the past 6 months: • myocardial infarction (MI) (if the visit 1 ECG reveals patterns consistent with a MI and the date of the event cannot be determined, then the patient can enter the study at the discretion of the investigator and the sponsor); • coronary artery bypass surgery or percutaneous coronary intervention • unstable angina • stroke 9. Any of the following ECG abnormalities: • Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation • second degree AV block (Mobitz 1 and 2); patients with pacemakers are not excluded. • third degree AV block; patients with pacemakers are not excluded. • prolonged QTc (> 500 ms) 10. GFR (estimated by Cockcroft-Gault formula) < 30 mL/min at Visit 1. For detailed exclusion criteria, please refer to the full protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the effect of vildagliptin on left ventricular function in patients with T2DM and CHF (NYHA class I-III) by showing that vildagliptin is at least not inferior to placebo with respect to change in left ventricular ejection fraction (LVEF) after 52 weeks of treatment.;Secondary Objective: • To evaluate the overall safety and tolerability of vildagliptin versus placebo in patients with T2DM and CHF (NYHA class I – III) over 52 weeks of treatment with special regards to signs and symptoms of heart failure. • To evaluate the efficacy of vildagliptin in patients with T2DM and CHF (NYHA class I-III) by assessing the HbA1c reduction with vildagliptin compared to placebo after 16 weeks of treatment. ;Primary end point(s): The primary outcome variable is change from baseline in LVEF (%) at Week 52, regardless of rescue medication use. Baseline is the measurement obtained on the day of Screening (Week -2, Visit 1). | — |
Countries
Czech Republic, Denmark, Estonia, Germany, Greece, Italy, Latvia, Lithuania, Slovakia
Contacts
Public ContactInformacní služba - klin. hodnocení
Novartis s.r.o.
Outcome results
None listed