Pharmacokinetics and Pharmacodynamics of subcutaneous applied insulin aspart administered with the FlexPen® insulin pen compared to inhaled insulinadministered with the Exubera® device

• Conditions: Type 1 and Type 2 Diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10012614Term: Diabetes mellitus NOS

• Registration Number: EUCTR2007-002060-10-DE
• Lead Sponsor: ikfe GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-31
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified