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

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

Sponsors

Lead sponsor: Biodel

Source Biodel
Brief Summary

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

Overall Status Completed
Start Date June 2006
Completion Date January 2008
Primary Completion Date January 2008
Phase Phase 2
Study Type Interventional
Primary Outcome
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 Outcome
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
Enrollment 24
Condition
Intervention

Intervention type: Drug

Intervention name: Regular Human Insulin

Description: Individual dose of RHI administered subcutaneously

Arm group label: Regular Human Insulin

Intervention type: Drug

Intervention name: Lispro

Description: Individual dose of lispro administered subcutaneously

Arm group label: Lispro

Intervention type: Drug

Intervention name: VIAject

Description: Individual dose of VIAject administered subcutaneously

Arm group label: VIAject

Intervention type: Drug

Intervention name: VIAject 50%

Description: Individual dose of VIAject 50% administered subcutaneously

Arm group label: VIAject 50%

Intervention type: Drug

Intervention name: VIAject/Insulin Glargine

Description: VIAject mixed wiht insulin glargine and administered subcutaneously

Arm group label: VIAject/Insulin glargine

Intervention type: Drug

Intervention name: Insulin Glargine/VIAject

Description: Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

Arm group label: Insulin Glargine/VIAject

Eligibility

Criteria:

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.

Gender: All

Minimum age: 19 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Marcus Hompesch, MD Principal Investigator Profil Institute for Clinical Research, Inc.
Location
facility Profil Institute for Clinical Research, Inc. (PICR)
Location Countries

United States

Verification Date

July 2015

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 6
Arm Group

Arm group label: Regular Human Insulin

Arm group type: Experimental

Description: Single injection

Arm group label: Lispro

Arm group type: Experimental

Description: Single injection

Arm group label: VIAject

Arm group type: Experimental

Description: Single injection

Arm group label: VIAject 50%

Arm group type: Experimental

Description: Single injection

Arm group label: VIAject/Insulin glargine

Arm group type: Experimental

Description: Single injection

Arm group label: Insulin Glargine/VIAject

Arm group type: Experimental

Description: Single injection

Study Design Info

Allocation: Non-Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov