A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro

Completed · Phase 2

Conditions studied: Diabetes Mellitus

In brief

Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.

Key facts

Study ID

NCT01000922

Run by

Biodel

People needed

24

Starts

2006-06-01

Expected to finish

2008-01-01

Last updated by the study team

2015-07-29

Who can join

Age: 19 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Profil Institute for Clinical Research, Inc. (PICR) — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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