Status:
COMPLETED
A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro
Lead Sponsor:
Biodel
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
19-70 years
Phase:
PHASE2
Brief Summary
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
Eligibility Criteria
Inclusion
- Established diagnosis of type 1 diabetes for not less than 5 years
- HbA1c values of not more than 9%
- Age: 19 to 70 years
- Sex: Male or Female
- Body Mass Index: 18 - 28 kg/m2
- Informed consent must be obtained in writing for all volunteers.
Exclusion
- Type 2 Diabetes mellitus.
- History of hypersensitivity to any of the components in the study medication.
- History of severe or multiple allergies.
- Treatment with any other investigational drug in the last 1 month before study entry.
- Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
- Progressive disease likely to prove fatal (e.g. malignancies).
- Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
- Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
- Blood donation within the last 30 days.
- A women who is lactating.
- Pregnant women or women intending to become pregnant during the study.
- A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
- Positive Serology for HIV, Hepatitis B or Hepatitis C.
- Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
- A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01000922
Start Date
June 1 2006
End Date
January 1 2008
Last Update
July 29 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States, 91911