A multicenter, double-blind, randomized, parallel-group study to compare the effect of 24 weeks treatment with LAF237 (50 mg qd or bid) to placebo as add-on therapy to glimepiride in patients with type 2 diabetes inadequately controlled with sulfonylurea monotherapy

• Conditions: Patients with type 2 diabetes

• Registration Number: EUCTR2004-001546-32-LT
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-27
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 345

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 < 270 mg/dL (15 mmol/L) 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

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.

Study & Design

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