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

Biodel

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: VIAject/Insulin Glargine; Drug: VIAject 50%; Drug: VIAject; Drug: Insulin Glargine/VIAject; Drug: Regular Human Insulin; Drug: Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT01000922

VIAJECT™-010JM

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 6 patient groups

Regular Human Insulin

Experimental group

Description:

Single injection

Treatment:

Drug: Regular Human Insulin

Lispro

Experimental group

Description:

Single injection

Treatment:

Drug: Lispro

VIAject

Experimental group

Description:

Single injection

Treatment:

Drug: VIAject

VIAject 50%

Experimental group

Description:

Single injection

Treatment:

Drug: VIAject 50%

VIAject/Insulin glargine

Experimental group

Description:

Single injection

Treatment:

Drug: VIAject/Insulin Glargine

Insulin Glargine/VIAject

Experimental group

Description:

Single injection

Treatment:

Drug: Insulin Glargine/VIAject