E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
Metabolic disease in which a person has high blood sugar because the body does not produce enough insulin |
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E.1.1.2 | Therapeutic area | Diseases [C] - Hormonal diseases [C19] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10012608 |
E.1.2 | Term | Diabetes mellitus insulin-dependent |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 compare the pharmacokinetic response (based on the time to maximum observed serum insulin concentration) of rapid acting insulin aspart after sub-cutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with type 1 diabetes. |
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E.2.2 | Secondary objectives of the trial |
To characterize and compare the pharmacokinetic and pharmacodynamic profiles of rapid acting insulin aspart after sub-cutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with T1DM. To assess the safety and tolerability of rapid acting insulin aspart after subcutaneous injection of a defined dose (volume) at 1 versus 9 injection sites in patients with T1DM.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Informed consent obtained after being advised of the nature of the study Male or female aged 18-60 years (both inclusive) Type 1 diabetes treated with multiple daily insulin injection or continuous subcutaneous insulin infusion for 12 months Fasting C-peptide < 0.3nmol/L Body mass index 20.0-28.0 kg/m² (both inclusive) HbA1c < 10%
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E.4 | Principal exclusion criteria |
Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods Skin pathology or condition prohibiting needle insertion/insulin administration as judged by the investigator History of bleeding disorder Current participation in another clinical study Significant acute or chronic illness that might interfere with subject safety or integrity of results as judged by the investigator Smoker (defined as >5 cigarettes/d) Lipodystrophy Current treatment with systemic (oral or i.v.) corticosteroids, monoamine oxidase (MAO) inhibitors, non-selective beta-blockers, growth hormone, herbal products or non-routine vitamins. Furthermore, thyroid hormones are not allowed unless the use of these has been stable during the past 3 months. Significant history of alcoholism or drug abuse or a positive result in urine drug/alcohol screen.
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Pharmacokinetic Endpoint: tmax(ins), time to maximum observed serum insulin aspart concentration |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Secondary Pharmacokinetic Endpoints: t10%max(ins), time to reach 10% of maximum observed serum insulin aspart concentration t50%max(ins), time to reach 50% of maximum observed serum insulin aspart concentration Cmax(ins), maximum observed serum insulin aspart concentration AUC0-8(ins), area under the serum insulin aspart concentration-time curve from 0-8 hours AUC0-0.5h(ins), AUC0-1h(ins), AUC0-2h(ins), AUC0-4h(ins), AUC0-6h(ins), area under the serum insulin aspart concentration-time curve for different time frames AUC0-tmax(ins), area under the serum insulin aspart concentration-time curve from 0 to timepoint of maximum observed serum insulin aspart concentration AUC0-∞(ins), area under the serum insulin aspart concentration-time curve from 0 to infinity Onset of appearance, time from trial product administration until the first time serum insulin aspart concentration > 30 pmol/L after dosing
Secondary Pharmacodynamic Endpoints: tmax(GIR), time to maximum glucose infusion rate t10% max(GIR), time to reach 10% of maximum glucose infusion rate t50% max(GIR), time to reach 50% of maximum glucose infusion rate GIRmax, maximum glucose infusion rate AUC0-8h(GIR), area under the glucose infusion rate curve from 0-8 hours AUC0-0.5h(GIR), AUC0-1h(GIR), AUC0-2h(GIR), AUC0-4h(GIR), AUC0-6h(GIR), area under the glucose infusion rate curve for different time frames AUC0-tmax(GIR), area under the glucose infusion rate curve from 0 to time to maximum glucose infusion rate AUC0-∞(GIR), area under the glucose infusion rate curve from 0 ti infinity Onset of action, defined as time from trial product administration until plasma glucose concentration has decreased at least 5mg/dl from baseline (t=0) Duration of action, defined as time from onset of action until plasma glucose exceeds 150mg/dl without any glucose infusion
Safety Endpoints: Adverse events Laboratory safety variable Onset of appearance, time from trial product administration until the first time serum insulin aspart concentration > 30 pmol/L after dosing |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.6 | Cross over | Yes |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Novorapid single vs. multiple injection sites |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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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Drop-outs will be replaced. The study is considered as complete if 8 eligible patients complete the whole study. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |