Diabetes mellitus MedDRA version: 13.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 13.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: BioChaperone® rhInsulin
Product Code: BioChaperone® rhInsulin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN HUMAN
Concentration unit: IU/ml international uni
Sponsors
Adocia SA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: The secondary objective is to compare the pharmacodynamic profile of BioChaperone® rhInsulin in comparison to insulin aspart.;Primary end point(s): - Time to reach Maximal Insulin Concentration (TINSmax);Timepoint(s) of evaluation of this end point: End of study (after approx. three months) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) ;Timepoint(s) of evaluation of this end point: End of study (after approx. three months) | — |
Countries
Germany
Contacts
Public ContactCRO
ikfe CRO GmbH
Outcome results
None listed