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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01000922

Enrollment

Registered

2009-10-23

Start date

2006-06-30

Completion date

2008-01-31

Last updated

2015-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Mealtime Insulin, Rapid acting insulin, Ultra fast VIAject, prandial insulin

Brief summary

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

Interventions

DRUGRegular Human Insulin

Individual dose of RHI administered subcutaneously

DRUGLispro

Individual dose of lispro administered subcutaneously

DRUGVIAject

Individual dose of VIAject administered subcutaneously

DRUGVIAject 50%

Individual dose of VIAject 50% administered subcutaneously

DRUGVIAject/Insulin Glargine

VIAject mixed wiht insulin glargine and administered subcutaneously

DRUGInsulin Glargine/VIAject

Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

Study design

Allocation

NON_RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 70 Years

Healthy volunteers

Inclusion criteria

1. Established diagnosis of type 1 diabetes for not less than 5 years 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

1. Type 2 Diabetes mellitus. 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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026