E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
type 2 diabetic patients with insufficient glycaemic control |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10049746 |
E.1.2 | Term | Insulin-requiring type II diabetes mellitus |
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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 investigate the efficacy, safety and tolerability of BI 1356 (5 mg once daily) versus placebo administered for 24 weeks as monotherapy in patients with type 2 diabetes mellitus and insufficient glycaemic control defined as HbA1c >=7% and <=10%. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will be evaluated by the followings enpoints: The occurrence of a treat to target efficacy response, that is an HbA1c under treatment of <7.0% or <6.5% after 24 weeks of treatment Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 24 weeks of treatment HBA1c reduction from baseline by Visit over time The change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment Meal Tolerance Test (MTT): change from baseline of two-hour postprandial glucose (2hPPG) after 24 weeks of treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Male and female patients with a diagnosis of type 2 diabetes mellitus, either treatment naive or treated with one antidiabetic medication. Antidiabetic therapy has to be unchanged for 10 weeks prior to the informed consent -Diagnosis of type 2 diabetes mellitus prior to informed consent -Glycosylated haemoglobin A1 (HbA1c) at Visit 1a (Screening) For patients undergoing washout of previous medication: HbA1c >=6.5 to <=9.0%. For patients not undergoing wash out of previous medication: HbA1c >=7.0 to <=10.0% -Glycosylated haemoglobin A1 (HbA1c) >=7.0 to <=10.0% at Visit 2 (Start of Runin) -Age >=18 and <80 years at Visit 1a (Screening) -BMI <=40 kg/m**2 (Body Mass Index) at Visit 1a (Screening) -Signed and dated written informed consent by date of Visit 1a in accordance with GCP and local legislation |
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E.4 | Principal exclusion criteria |
-Myocardial infarction, stroke or TIA within 6 months prior to informed consent -Impaired hepatic function, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined at Visit 1a -Known hypersensitivity or allergy to the investigational product or its excipients -Treatment with more than one antidiabetic drug within 10 weeks prior to informed consent -Treatment with rosiglitazone or pioglitazone within 3 months prior to informed consent -Treatment with GLP-1 analogues (e.g. exenatide) within 3 months prior to informed consent -Treatment with insulin within 3 months prior to informed consent -Treatment with anti-obesity drugs (e.g. sibutramine, orlistat, rimonabant) within 3 months prior to informed consent -Alcohol abuse within the 3 months prior to informed consent that would interfere with trial participation or drug abuse -Participation in another trial with an investigational drug within 2 months prior to informed consent -Pre-menopausal women (last menstruation <= 1 year prior to informed consent) who: - are nursing or pregnant - or are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence and vasectomised partner. No exception will be made -Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
the change from baseline in HbA1c (HbA1c 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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
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 | No |
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
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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 | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |