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

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

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Drug: Regular Human Insulin
* Drug: Lispro
* Drug: VIAject
* Drug: VIAject 50%
* Drug: VIAject/Insulin Glargine
* Drug: Insulin Glargine/VIAject


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regular Human Insulin<br>Single injection | Drug: Regular Human Insulin<br>* Individual dose of RHI administered subcutaneously<br>|
| Experimental: Lispro<br>Single injection | Drug: Lispro<br>* Individual dose of lispro administered subcutaneously<br>|
| Experimental: VIAject<br>Single injection | Drug: VIAject<br>* Individual dose of VIAject administered subcutaneously<br>|
| Experimental: VIAject 50%<br>Single injection | Drug: VIAject 50%<br>* Individual dose of VIAject 50% administered subcutaneously<br>|
| Experimental: VIAject/Insulin glargine<br>Single injection | Drug: VIAject/Insulin Glargine<br>* VIAject mixed wiht insulin glargine and administered subcutaneously<br>|
| Experimental: Insulin Glargine/VIAject<br>Single injection | Drug: Insulin Glargine/VIAject<br>* Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments |  | 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments. |  | 8 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mealtime Insulin, Rapid acting insulin, Ultra fast VIAject, prandial insulin