Trial | NCT01000922  Report issue

Title

A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro
A Single Center, Randomized, Open-Label, Crossover Study, Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro Either in Combination With a Basal Insulin Infusion or With Insulin Glargine Relative to a Standardized Meal in Patients With Type 1 Diabetes

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
Study Started
Jun 30
2006
Primary Completion
Jan 31
2008
Study Completion
Jan 31
2008
Last Update
Jul 29
2015
Estimate

Drug Regular Human Insulin

Individual dose of RHI administered subcutaneously

Drug Lispro

Individual dose of lispro administered subcutaneously

Drug VIAject

Individual dose of VIAject administered subcutaneously

Drug VIAject 50%

Individual dose of VIAject 50% administered subcutaneously

Drug VIAject/Insulin Glargine

VIAject mixed wiht insulin glargine and administered subcutaneously

Drug Insulin Glargine/VIAject

Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

Regular Human Insulin Experimental

Single injection

Lispro Experimental

Single injection

VIAject Experimental

Single injection

VIAject 50% Experimental

Single injection

VIAject/Insulin glargine Experimental

Single injection

Insulin Glargine/VIAject Experimental

Single injection

Criteria 

Inclusion Criteria:

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 Criteria:

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.
No Results Posted