E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Body processes [G] - Metabolic Phenomena [G03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
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 |
|
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 phase IIa trial is to assess the non-inferiority of BioChaperone® rhInsulin in comparison to insulin aspart with regard to the onset of absorption after 3 injections of each product. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the pharmacodynamic profile of BioChaperone® rhInsulin in comparison to insulin aspart. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female subjects. 2. Age: 18 –50 years. 3. Diabetes mellitus type 1 (with intensified insulin therapy or pump therapy) (C-Peptide < 1 ng/mL) 4. BMI 18-29 kg/m2 5. HbA1c < 8.5 % 6. Informed consent must be obtained for all volunteers in writing 7. Subject consents that his family physician will be informed of trial participation
|
|
E.4 | Principal exclusion criteria |
1. Diabetes mellitus 2 2. Poor glycemic control or recent changes (within 3 months) in baseline diabetes treatment 3. History of hypersensitivity to the study drugs or to drugs with similar chemical structures 4. History of severe or multiple allergies 5. Evidence of severe secondary complications of diabetes (neuropathy, nephropathy or proliferative retinopathy, macro and micro-angiopathies) as judged by investigator 6. Any systemic treatment with drugs known to interfere with glucose metabolism , and diabetes progression such as systemic or local corticoids, non-selective beta-blockers, and monoamine oxidase (MAO) inhibitors within 3 months prior to randomization 7. Blood donation within the last 3 months. 8. Excessive physical activities in the last 24 hrs before the dosing visits. 9. History of drug or alcohol abuse within the last five years prior to screening. 10. Treatment with any other investigational drug within 3 months prior to screening. 11. Progressive fatal disease. 12. History of significant cardiovascular, respiratory, gastrointestinal, hepatic (ALAT and/or ASAT > 3 times the normal reference range), renal (creatinine >1.5 mg/dl in men and > 1.1 mg/dl in female), uncontrolled cholesterol (LDL>1g/L) neurological, psychiatric and/or hematological disease as judged by the investigator. 13. Uncontrolled hypertension (HTA>140/80mm Hg) 14. HIV1, HIV2, Hepatitis B, Hepatitis C positive. 15. Sexually active women of childbearing potential not consistently and correctly practicing birth control by implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner. 16. Pregnancy or breast feeding 17. Lack of compliance or other similar reason that according to investigator precludes satisfactory participation in the study 18. History or evidence of use of any tobacco – or nicotine-containing product within 6 months of screening 19. Clinical or surgical scares in the intended abdominal region 20. Daily insulin requirement (> 60 IU) 21. Patients with increased thrombosis risk |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Time to reach Maximal Insulin Concentration (TINSmax) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
End of study (after approx. three months) |
|
E.5.2 | Secondary end point(s) |
- Variability of the GIR-AUC (0-6h) - Maximal GIR (GIRmax) - as determined by the euglycemic glucose clamp technique - Time to maximal GIR (TGIRmax) - Time to halfmaximal GIR before and after Tmax (TGIR0.5max, TGIR-0.5max) - GIR AUC: AUC-GIR (0-3h) and AUC-GIR (0-6h) - Time to reach baseline GIR - Maximal Insulin Concentration (INSmax) - Variability of INS-AUC (0-6 h) - Other PK parameters (TINS-0.5max) - AUC-INS (0-1h), AUC-INS (0-3h), AUC-INS (0-6h)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
End of study (after approx. three months) |
|
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 | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | 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 | No |
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
|
Trial timelines as outlined in the protocol: - Last patient out is planned for July 2011 |
|
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 | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |