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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Regular Human Insulin; Drug: Lispro; Drug: VIAject; Drug: VIAject 50%; Drug: VIAject/Insulin Glargine; Drug: Insulin Glargine/VIAject

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Chula Vista, California, United States, 91911
      • Profil Institute For Clinical Research, Inc. (Picr)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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 Measures

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

Collaborators and Investigators

• Sponsor: Biodel

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): January 1, 2008

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: October 22, 2009
• First Posted (Estimate): October 23, 2009

Study Record Updates

• Last Update Posted (Estimate): July 29, 2015
• Last Update Submitted That Met QC Criteria: July 28, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: prandial insulin; Mealtime Insulin; Rapid acting insulin; Ultra fast VIAject
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Glargine
• Other Study ID Numbers: VIAJECT™-010JM