Patients with type 2 diabetes
Conditions
Interventions
Product Code: LAF237
Pharmaceutical Form: Tablet
Concentration unit: mg milligram(s)
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Amaryl 4 m
Sponsors
Novartis Finland Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria: male or female (non-fertile or of childbearing potential using a medically approved birth control method) patients with type 2 diabetes, previously treated with a sulfonylurea for at least 3 months, aged 18-80 years, body mass index of 22-45 kg/m2, HbA1c 7.5-11% inclusive, FPG =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a history of type 1 diabetes, diabetes that is a result of pancreatic injury or secondary forms of diabetes, acute metabolic diabetic complications within past 6 months; evidence of significant diabetic complications; acute infections which may affect blood glucose control within the past 4 weeks; Torsades de Pointes, ventricular tachycardia, ventricular fibrillation; percutaneous coronary intervention in the past 3 months; myocardial infarction, coronary artery bypass surgery, or unstable angina 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 within the last 5 years; liver disease; acromegaly or treatment with growth hormone; known sensitivity to glimepiride; treatment with any oral antidiabetic other than sulfonylureas within the past 3 months; chronic insulin treatment within the past 6 months; chronic oral or parenteral corticosteroid treatment within the past 8 weeks; treatment with class Ia, Ib, Ic, or III anti-arrhythmics; significant laboratory abnormalities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of add-on therapy with LAF237 to glimepiride in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy by testing the hypothesis that the HbA1c reduction with LAF237 (50 mg qd or bid) is superior to that with placebo after 24 weeks of treatment.;Secondary Objective: To demonstrate the efficacy and safety of add-on therapy with LAF237 to glimepiride with prior sulfonylurea monotherapy by testing the hypothesis that the FPG reduction with LAF237 (50 mg qd or bid) is superior or that safety is comparable to that with placebo after 24 weeks of treatment. The efficacy of add-on therapy with LAF237 to glimepiride with prior sulfonylurea monotherapy by showing that the responder rates (see Section 7.4 for definitions) with LAF237 (50 mg qd or bid) are greater than those with placebo after 24 weeks of treatment. The efficacy of add-on therapy with LAF237 to glimepiride with prior sulfonylurea monotherapy across baseline HbA1c subgroups to assess whether or not the therapeutic efficacy of LAF237 (lowering of HbA1c with 50 mg qd or bid vs placebo) is greater in patients with high baseline HbA1c (>9%) than patients with lower baseline HbA1c (= 9%) after 24 weeks of treatment. ;Primary end point(s): To demonstrate the efficacy of add-on therapy with LAF237 to glimepiride in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy by testing the hypothesis that the HbA1c reduction with LAF237 (50 mg qd or bid) is superior to that with placebo after 24 weeks of treatment. | — |
Countries
Finland, Lithuania, Sweden
Outcome results
None listed