A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 52 Weeks Treatment with LAF237 50 mg qd to Placebo in Drug-Naïve Patients with Type 2 Diabetes and Mild Hyperglycemia

• Conditions: Type 2 Diabetes

• Registration Number: EUCTR2004-000539-27-FI
• Lead Sponsor: ovartis Finland Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-08-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

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

Study & Design

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