E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type 2 diabetes with insufficient glycaemic control (HbA1c 7.0-10%) despite background therapy with a sulfonylurea drug |
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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 | 10012601 |
E.1.2 | Term | 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 |
• HbA1c change from baseline at 18 weeks |
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E.2.2 | Secondary objectives of the trial |
• Fasting plasma glucose (FPG) change from baseline at 18 weeks • Occurrence of a treat-to-target response (i.e., an HbA1c during treatment of <7.0%) • Occurrence of relative efficacy response (HbA1c lowering by at least 0.5% after 18 weeks of treatment) • HbA1c reduction from baseline by visit over time • The change from baseline in fasting plasma glucose (FPG) by visit over time • The occurrence of treat to target efficacy response, that is an HbA1c under treatment of <6.5% after 18 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 and previously treated with sulfonylurea drug alone or with not more than one other antidiabetic drug • Antidiabetic therapy has to be unchanged for 10 weeks prior to informed consent and patients should receive standard diet and exercise counselling • Sulfonylurea dose of at least ½ the maximum dose (or less if documented as maximum tolerated dose of at least 12 weeks) • Diagnosis of type 2 diabetes prior to informed consent • HbA1c at Visit 1a (Screening): o For patients undergoing wash out of previous medication: HbA1c ≥7.0 to ≤9.0% o For patients not undergoing wash-out of previous medication: HbA1c ≥7.5 to ≤10.0% • Glycosylated haemoglobin A1 (HbA1c) ≥7.5 to ≤10 % at Visit 2 (Start of Run in) • Age 18-80 years at Visit 1a (Screening) • BMI (body mass index) ≤40 kg/m2 at Visit 1a (Screening)
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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), or elevated total bilirubin above 3xULN, as determined at Visit 1a • Known hypersensitivity or allergy to the investigational product or its excipients or the patients’ sulfonylurea drug or placebo • Treatment with thiazolidinediones (e.g., rosiglitazone, pioglitazone) within 3 months prior to informed consent • Treatment with an injectable GLP-1 analogue (e.g., exenatide) within 3 months prior to informed consent • Chronic daily 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 or drug abuse within the 3 months prior to informed consent that would interfere with trial participation. • 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, double barrier method, female surgical sterilization, or vasectomised partner. • Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent. • Renal failure or renal impairment (calculated glomerular filtration rate [GFR] <30 mL/min as determined at Visit 1a) • Unstable or acute congestive heart failure • Hereditary galactose intolerance
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E.5 End points |
E.5.1 | Primary end point(s) |
change from baseline in HbA1c (HbA1c after 18 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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 11 |
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 | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 10 |