Type 1 and Type 2 Diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012614 Term: Diabetes mellitus NOS
Conditions
Interventions
Trade Name: NovoRapid
Product Name: NovoRapid FlexPen 100 U/ml, solution for injection in a prefilled pen
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Insulinaspart
Concentration u
Sponsors
ikfe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before conduct of any study-related activities (a study related activity is any procedure that would not have been performed during normal clinical management of the patient) 2. Patients with diabetes mellitus type 1 or type 2 3. Male or female, aged = 18 years (only patients with type 1 diabetes); male or female aged = 45 years (only patients with type 2 diabetes) 4. Pharmacological antidiabetic treatment with at least two oral antidiabetic drugs for at least 2 years (only for type 2 diabetic patients) 5. Type 1 and type 2 diabetes duration = 2 years 6. HbA1c in between and including the values of 6.6 and 10.9%. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of known hypersensitivity to any of the components in the study medication 2. Use of tobacco within the last 6 months 3. History of severe or multiple allergies 4. Treatment with any other investigational drug within the last 30 days before study entry 5. Progressive disease likely to prove fatal 6. History of malignant disease within the past 5 years 7. History of drug / alcohol abuse within the past 5 years 8. A woman who is breast feeding 9. Pregnant women or women intending to become pregnant during the study 10. A sexually active woman of childbearing potential not actively and consistently practicing birth control by using a medically accepted device or therapy 11. History of use of insulin for a consecutive period of at least 5 days (only for patients with type 2 diabetes) 12. Severe neuropathy, visual impairment and/or motor disabilities as judged by the investigator 13. Mental or physical incapacity, unwillingness or language barriers precluding adequate understanding or co-operation 14. A history of lack of compliance with medical instructions 15. Clinically significant physical or laboratory findings excluding the patient from the study participation as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the impact of insulin delivery by subcutaneous injection of insulin aspart with the FlexPen® vs. inhalation of Exubera® on pharmakokinetic and pharmacodynamic profile (e.g. AUC[GIR]) in patients with type 1 and type 2 diabetes.;Secondary Objective: To show patient preference or equal ranking respectively of insulin injection with NovoRapid® FlexPen® against inhaled insulin Exubera®.;Primary end point(s): | — |
Countries
Germany
Outcome results
None listed