E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | 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 |
The primary objective of this study is to assess whether insulin detemir, when injected once-daily at an individually appropriate time (either before breakfast or at bedtime), can provide superior blood glucose control to insulin glargine injected indiscriminantly at bedtime, in people who had clearly different dose requirements, day and night, when their insulin was previously given as a twice-daily regimen.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives will include the assessment of any between-treatment differences in single point plasma glucose levels or multi-point blood glucose profile, HbA1c, incidence of hypoglycaemia, blood glucose variability, weight change, or lipid profile. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient criteria to be eligible for this study will consist of the following: • Males and females aged ≥18 years, diagnosed with type 2 diabetes, who are willing to give informed consent • Patients currently receiving treatment with two insulin injections daily (morning and evening) of either NPH, or a fixed ratio human insulin or insulin analogue premix (such as 30% soluble / 70% protaminated), with or without concomitant use of oral glucose-lowering medication (OGLDs), which will be left unchanged during the trial. • Insulin treatment as described above to have been taken for a duration of at least 2 months • Patients able and willing to perform self-monitoring of plasma glucose
Patients will be screened for the following inclusion criteria: • A ratio of morning insulin dose:evening insulin dose >1.3:1 (peripheral insulin resistance substudy) or • A ratio of evening insulin dose:morning insulin dose >1.3:1 (hepatic glucose output substudy).
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E.4 | Principal exclusion criteria |
Patients to be excluded from this study will include: • Patients with HbA1c >9.0 or <6.5 % at entry visit • Patients with body mass index >40.0 kg/m2 at entry visit • Patients who are pregnant or for whom pregnancy during the trial is a possibility • Patients currently receiving treatment with thiazolidinediones or meglitinide derivatives, that cannot be stopped for the duration of the trial • Patients with high insulin dose requirements >100 U/day at entry visit • Patients on mixed insulin regimens, such as NPH insulin and a premixed insulin, or different ratios of premixed insulin morning and evening • Patients with known or suspected allergy to trial products or related products • Any condition that the local investigator feels would interfere with trial participation or the evaluation of results
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients (responders) achieving average pre-breakfast plasma glucose < 6.5 mmol/l and pre-dinner plasma glucose < 6.5 mmol/l in the last week of study, without hypoglycaemia in the last 4 weeks of the study confirmed by a blood glucose reading of < 3.5 mmol/l. |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 7 |
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 | 7 |