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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000922
• Other study ID #: VIAJECT™-010JM
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2009
• Last updated: July 28, 2015
• Start date: June 2006
• Est. completion date: January 2008

Study information

• Verified date: July 2015
• Source: Biodel
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Regular Human Insulin
Individual dose of RHI administered subcutaneously
• Lispro
Individual dose of lispro administered subcutaneously
• VIAject
Individual dose of VIAject administered subcutaneously
• VIAject 50%
Individual dose of VIAject 50% administered subcutaneously
• VIAject/Insulin Glargine
VIAject mixed wiht insulin glargine and administered subcutaneously
• Insulin Glargine/VIAject
Individual dose of VIAject and Insulin Glargine administered seperately and subcutaneously

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research, Inc. (PICR)	Chula Vista	California

Sponsors (1)

Lead Sponsor	Collaborator
Biodel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments		8 hours	No
Secondary	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	No