E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 < 270 mg/dL (15 mmol/L) and agreement to maintain prior diet and exercise. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |