A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro
NCT ID: NCT01000922
Last Updated: 2015-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
24 participants
INTERVENTIONAL
2006-06-30
2008-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Regular Human Insulin
Single injection
Regular Human Insulin
Individual dose of RHI administered subcutaneously
Lispro
Single injection
Lispro
Individual dose of lispro administered subcutaneously
VIAject
Single injection
VIAject
Individual dose of VIAject administered subcutaneously
VIAject 50%
Single injection
VIAject 50%
Individual dose of VIAject 50% administered subcutaneously
VIAject/Insulin glargine
Single injection
VIAject/Insulin Glargine
VIAject mixed wiht insulin glargine and administered subcutaneously
Insulin Glargine/VIAject
Single injection
Insulin Glargine/VIAject
Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously
Interventions
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Regular Human Insulin
Individual dose of RHI administered subcutaneously
Lispro
Individual dose of lispro administered subcutaneously
VIAject
Individual dose of VIAject administered subcutaneously
VIAject 50%
Individual dose of VIAject 50% administered subcutaneously
VIAject/Insulin Glargine
VIAject mixed wiht insulin glargine and administered subcutaneously
Insulin Glargine/VIAject
Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously
Eligibility Criteria
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Inclusion Criteria
2. HbA1c values of not more than 9%
3. Age: 19 to 70 years
4. Sex: Male or Female
5. Body Mass Index: 18 - 28 kg/m2
6. Informed consent must be obtained in writing for all volunteers.
Exclusion Criteria
2. History of hypersensitivity to any of the components in the study medication.
3. History of severe or multiple allergies.
4. Treatment with any other investigational drug in the last 1 month before study entry.
5. Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
6. Progressive disease likely to prove fatal (e.g. malignancies).
7. Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
8. Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
9. Blood donation within the last 30 days.
10. A women who is lactating.
11. Pregnant women or women intending to become pregnant during the study.
12. A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
13. Positive Serology for HIV, Hepatitis B or Hepatitis C.
14. Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
15. A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
19 Years
70 Years
ALL
No
Sponsors
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Biodel
INDUSTRY
Responsible Party
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Principal Investigators
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Marcus Hompesch, MD
Role: PRINCIPAL_INVESTIGATOR
Profil Institute for Clinical Research, Inc.
Locations
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Profil Institute for Clinical Research, Inc. (PICR)
Chula Vista, California, United States
Countries
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Other Identifiers
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VIAJECT™-010JM
Identifier Type: -
Identifier Source: org_study_id
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