Type 2 Diabetes mellitus
Conditions
Interventions
Product Code: LAF237
Pharmaceutical Form: Tablet
INN or Proposed INN: vildagliptin
Current Sponsor code: LAF237
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: Male or female (non-fertile or using a medically approved birth control method); age range 18-78 years inclusive; patients with type 2 diabetes who have received metformin for at least three months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks prior to visit 1; agreement to maintain the same dose of metformin throughout the study; body mass index (BMI) in the range of 22-45 kg/m2 inclusive; HbA1c 7.5% to 11% inclusive; FPG ? 15 mmol/L (270 mg/dL); and agreement to maintain prior diet and exercise. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: Pregnant or lactating female; a history of type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of diabetes; acute metabolic diabetic complications within the past 6 months; evidence of significant diabetic complications; acute infections which may affect blood glucose control within 4 weeks prior to visit 1; a history of Torsades de pointes, sustained and clinically relevant ventricular tachycardia or ventricular fibrillation; percutaneous coronary intervention within the past 3 months; myocardial infarction, coronary artery bypass surgery, unstable angina, or stroke within the past 6 months; congestive heart failure requiring pharmacologic treatment; second degree AV block (Mobitz 1 and 2), third degree AV block, prolonged QTc; malignancy including leukemia and lymphoma (not including basal cell skin cancer) within the last 5 years; liver disease; renal disease or renal dysfunction; acromegaly or treatment with growth hormone or similar drugs; concurrent medical condition that may interfere with the interpretation of efficacy and safety data during the study; donation of one unit (500 mL) or more of blood, significant blood loss equaling to at least one unit of blood within the past 2 weeks or a blood transfusion within the past 8 weeks; contraindications and warnings according to the country specific label for metformin or gliclazide not listed in the other exclusion criteria; known sensitivity to gliclazide or other sulfur containing drugs; treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1; chronic insulin treatment (> 4 weeks of treatment in the absence of an intercurrent illness) within the past 6 months; chronic oral or parenteral corticosteroid treatment within 8 weeks prior to visit 1; treatment with class Ia, Ib and Ic or III anti-arrhythmics; investigational drug treatment within 4 weeks prior to visit 1 unless local health authority guidelines mandate a longer period; treatment with any drug with a known and frequent toxicity to a major organ system within the past 3 months; any of the following significant laboratory abnormalities: ALT, AST greater than 3 times the upper limit of the normal range, direct bilirubin greater than 1.3 times the upper limit of the normal range, serum creatinine levels = 132 ?mol/L (1.5 mg/dL) males, = 123?mol/L (1.4 mg/dL) females, or a history of abnormal creatinine clearance, TSH outside of normal range at visit 1, clinically significant laboratory abnormalities confirmed by repeat measurement (other than hyperglycemia, hyperinsulinemia, and glycosuria), fasting triglycerides ? 7.9 mmol/L (> 700 mg/dL); history of active substance abuse (including alcohol) within the past 2 years; and potentially unreliable patients, and those judged by the investigator to be unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To confirm the efficacy of add-on therapy with LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the HbA1c reduction with LAF237 is not inferior to that with gliclazide after 52 weeks of treatment.;Secondary Objective: Critical 1- To demonstrate safety of LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by showing that add-on therapy with LAF237 has a similar adverse event profile compared to gliclazide after 52 weeks of treatment. 2- To demonstrate efficacy of add-on therapy with LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by testing the hypothesis that the FPG reduction with LAF237 is not inferior to that with gliclazide after 52 weeks of treatment. 3- To demonstrate efficacy of add-on therapy with LAF237 in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy by showing that the responder rates with LAF237 are similar to those with gliclazide after 52 weeks of treatment.;Primary end point(s): Primary efficacy parameters HbA1c measured by ion exchange High Performance Liquid Chromatography (HPLC). | — |
Countries
Czech Republic, Denmark, Hungary, Italy, Slovakia, Spain, United Kingdom
Outcome results
None listed