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 | 9.1 |
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 aim of the study is to compare two -basal insulin regimens as insulin therapy initiation in ageing type 2 diabetic patients with insulin detemir versus NPH insulin given once daily in the morning. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this trial are to compare insulin detemir to NPH insulin therapy according to the following criteria, measured at 4 and 7 months (except for Quality of Life related measures which will be assessed at baseline and end of study) •Quality of Life (treatment satisfaction, health status, behavioural and psychosocial scoring) •Efficacy objectives - Percentage of subjects with HbA1c ≤ 8.0% - Glycaemic control as measured by 3-point Self Measured Plasma Glucose (SMPG) (Fasting, prelunch and predinner Plasma Glucose) - Within-subject variation of body weight during the trial - Percentage of patients achieving Fasting Plasma Glucose ≤8.8 mmol/L (160 mg/dL) - Within-subject variation of Plasma Glucose during the trial - Incidence of Hyperglycaemic episodes •Safety objectives - Incidence of hypoglycaemic episodes - Occurrence of adverse events during the trial •Insulin dose requirements
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Informed Consent must be obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). 2.Type 2 diabetes, 3.Subject ≥ 70 years old, 4.Subject insulin naïve and optimally treated by oral antidiabetics drugs (OAD) at maximum tolerated dose for at least 3 months and not achieving therapeutic targets 5.8.0% ≤ HbA1c ≤ 10.5% (local dosage within the last 6 months) 6.Able to comply with the requirements of the trial.
Moreover, the metabolic control appropriate for the patients to be included should target an HbA1c between 7.0% and 8.0%. Concomitant treatment: in case of previous metformin treatment, metformin will be continued at optimal dose, providing renal clearance assessed by MDRD > 60 ml/mn and no renal impairment occurs throughout the study. Thiazolidinediones must be discontinued at least 2 weeks before randomisation. Sulfonylureas and alpha-glucosidase inhibitors must be discontinued at randomisation. Elderly patients living in specific medical institutions are authorized to take part in the study, as judged by the Investigator, if they are able to give their informed consent, to understand and comply with the study procedures and if there is a benefit for the subject in taking part in the study.
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E.4 | Principal exclusion criteria |
1.Secondary diabetes, MODY (Maturity Onset Diabetes of the Young), 2.Previous treatment with insulin (except for short-term treatment with insulin for intercurrent illness as judged by the Investigator), 3.Proliferative retinopathy, maculopathy requiring treatment, 4.Hypoglycaemia unawareness as judged by the Investigator, recurrent major hypoglycaemia, 5.End stage liver disease (increased liver enzymes 4 fold), end stage renal disease assessed by MDRD < 30 ml/min or dialysed patient, acute heart failure, any acute cardiovascular event or cerebrovascular event less than 6 months, 6.Acute disease withpoor prognosis, 7.History of alcoholism, drug abuse, or psychiatric disease or personality disorders likely to invalidate voluntary consent or to prevent good compliance with the trial protocol, 8.Mental incapacity, unwillingness or language barrier precluding adequate understanding or co-operation (patients having a score of less than 15 in a previous MMSE in the last six months) and any conditions as judged by the investigator, 9.Legal incapacity or limited legal capacity (patients under guardianship or curatorship), 10.Concomitant medication for Alzheimer's treatment (Memantine, Anticholinesterasique treatment), 11.Participation in another clinical trial less than one month before inclusion in this trial, 12.Illness requiring repeated hospitalisation, 13.Known or suspected allergy to the insulin or any compositional component, 14.Anticipated change or new use in concomitant medication known to interfere with glucose metabolism, such as systemic corticotherapy more than 5 mg/day (prednisone) 15.Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, 16.Terminal illness
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E.5 End points |
E.5.1 | Primary end point(s) |
•Efficacy objectives at 4 months and 7 months - Glycaemic control as measured by centrally measured HbA1c - Glycaemic control as measured by mean self measurement of fasting plasma glucose (FPG), pre-lunch and pre-dinner plasma glucose - Percentage of subjects achieving HbA1c ≤8.0% - Percentage of subjects achieving HbA1c ≤8.0% without hypoglycaemia - Percentage of patients achieving mean fasting capillary glycaemia ≤8.8 mmol/L (160mg/d) - Within-subject variation in pre-breakfast, pre-lunch and pre-dinner capillary plasma glucose level (SMPG) during the trial - Incidence of hyperglycaemic episodes •Safety objectives - Incidence of hypoglycaemic episodes reported by the patient (all, major hypoglycaemic episodes when assistance to treat is required, minor hypoglycaemic episodes when plasma glucose is < 56 mg/dL (3.1mmol/L) and when the subject is able to deal with the episode himself or any symptom of hypoglycaemia if not confirmed by a plasma glucose measurement) during the trial (nocturnal and over the entire day), - Incidence of hypoglycaemic episodes defined as a self measured plasma glucose less than 56 mg/dL (3.1 mmol/L) - Occurrence of adverse events during the trial •Insulin doses requirements: total daily doses measured at 4 and 7 months in both groups
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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 | 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) | 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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 60 |
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 | 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 | 4 |