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 | 10045228 |
E.1.2 | Term | Type I 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 the trial is to compare the safety of insulin detemir produced by the NN729 process with insulin detemir produced by the current process (NN304), as measured by development of insulin cross-reacting antibodies, in subjects with type 1 diabetes during 12 months of treatment on a basal-bolus regimen with insulin detemir as basal insulin and insulin aspart as bolus. |
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E.2.2 | Secondary objectives of the trial |
•To compare the safety profiles by measurement of insulin antibody levels (the sum of insulin detemir specific antibodies and cross-reacting antibodies) and measurement of insulin detemir specific antibodies during 12 months treatment. •To compare the safety profiles by occurrence of adverse events during 12 months of treatment (including application site disorders). •To compare the safety profiles as measured by standard safety parameters (haematology, biochemistry), fundoscopy/fundusphotography, vital signs and weight during and/or after 12 months of treatment. •To compare the incidence of hypoglycaemic episodes during 12 months of treatment. Efficacy: •Glycaemic control as measured by HbA1c •Fasting Plasma Glucose (FPG) •9-point Plasma Glucose (PG) Profiles
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Informed consent 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.Subjects with type 1 diabetes according to clinical judgement 3.Duration of type 1 diabetes ≥12 months 4.Basal-bolus treatment for ≥3 months 5.Age ≥18 years of age 6.Body Mass Index (BMI) ≤ 35.0 kg/m2 7.HbA1c ≤ 12.0% at screening, based on analysis from central laboratory 8.Willing and able to perform self-monitoring of PG 9.Willing and able to adhere to the trial specific insulin regimen for the entire trial period
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E.4 | Principal exclusion criteria |
1.Subjects with proliferative retinopathy or maculopathy requiring acute treatment within the last six months 2.Recurrent major hypoglycaemia that may interfere with trial participation as judged by the Investigator 3.Impaired hepatic or renal function that according to the Investigator will interfere with trial participation 4.Cardiac problems as judged by the Investigator 5.Uncontrolled hypertension (treated and untreated) as judged by the Investigator 6.Known or suspected allergy to trial products or related products 7.Previous participation in this trial. Participation is defined as randomisation 8.Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures required by country specific law or practice. (For Germany the following contraceptive measures are regarded as adequate: Implants, injectables, combined oral contraceptives, hormonal intrauterine device (IUD), sexual abstinence and vasectomized partner). 9.Receipt of any trial drug within 1 month prior to this trial 10.Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
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E.5 End points |
E.5.1 | Primary end point(s) |
The change from baseline to week 52 of insulin cross-reacting antibodies.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | 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 | 14 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | 3 |
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 | 3 |