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

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Regular Human Insulin; Drug: Lispro; Drug: VIAject; Drug: VIAject 50%; Drug: VIAject/Insulin Glargine; Drug: Insulin Glargine/VIAject

• Registration Number: NCT01000922
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-22
• Study First Posted: 2009-10-23
• Status Verified: 2015-07
• Disposition First Submitted: 2015-07-28
• Disposition First Submitted QC: 2015-07-28
• Last Update Submitted: 2015-07-28
• Disposition First Posted: 2015-07-29
• Last Update Posted: 2015-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Regular Human Insulin	Regular Human Insulin	Single injection
Lispro	Lispro	Single injection
VIAject	VIAject	Single injection
VIAject 50%	VIAject 50%	Single injection
VIAject/Insulin glargine	VIAject/Insulin Glargine	Single injection
Insulin Glargine/VIAject	Insulin Glargine/VIAject	Single injection

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Profil Institute for Clinical Research, Inc. (PICR); 🇺🇸 Chula Vista, California, United States