Type 2 Diabetes
Conditions
Interventions
Product Code: LAF237A
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Tablet
Route of administra
Sponsors
Novartis Sverige AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female (non-fertile or using a medically approved birth control method); age =18 years; drug naïve patients with type 2 diabetes, diagnosed at least 8 weeks prior to visit 1; body mass index of 22-45 kg/m2 inclusive; HbA1c 6.2-7.5% inclusive 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: 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 NYHA class III or IV; 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; 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; 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 (> 7 consecutive days of 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 > 2.5 mg/dL (220 ?mol/L), TSH outside normal range at visit 1, clinically significant laboratory abnormalities, confirmed by repeat measurement (other than hyperglycemia, hyperinsulinemia, and glycosuria), fasting triglycerides ?700 mg/dL (>7.9 mmol/L); history of active substance abuse (including alcohol) within the past 2 years; potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of LAF237 in patients with type 2 diabetes and mild hyperglycemia (HbA1c 6.2-7.5%) by testing the hypothesis that the HbA1c reduction with LAF237 50 mg qd is superior to that with placebo after 52 weeks of treatment.;Primary end point(s): Primary efficacy parameters HbA1c measured by ion exchange High Performance Liquid Chromatography (HPLC) ;Secondary Objective: Critical: 1. To demonstrate safety of LAF237 in patients with type 2 diabetes and mild hyperglycemia by showing that LAF237 50 mg qd has a similar adverse event profile to placebo after 52 weeks of treatment. 2. To demonstrate efficacy of LAF237 in patients with type 2 diabetes and mild hyperglycemia by showing that the initial responder rates at 12 weeks and the responder rates at 52 weeks with LAF237 50 mg qd are greater than those with placebo. 3. To demonstrate efficacy of LAF237 in patients with type 2 diabetes and mild hyperglycemia by testing the hypothesis that the FPG reduction with LAF237 50 mg qd is superior to that with placebo after 52 weeks of treatment. 4. To demonstrate durability of effect of LAF237 in patients with type 2 diabetes and mild hyperglycemia by testing the hypothesis that the coefficient of failure for HbA1c of LAF237 between Week 24 and Week 52 is lower than that of placebo | — |
Countries
Finland, Spain, Sweden
Outcome results
None listed