A Study Comparing the Pharmacodynamic Properties of Insulin VIAJECT™, Regular Human Insulin, and Insulin Lispro
This study has been completed.
Sponsor:
Biodel
Information provided by (Responsible Party):
Biodel
ClinicalTrials.gov Identifier:
NCT01000922
First received: October 21, 2009
Last updated: October 4, 2011
Last verified: August 2010
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Purpose
Evaluation of post-prandial blood glucose excursions after a standardized meal and pre meal injections of individual doses of the study insulins.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Regular Human Insulin Drug: Lispro Drug: VIAject Drug: VIAject 50% Drug: VIAject/Insulin Glargine Drug: Insulin Glargine/VIAject |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Biodel:
Primary Outcome Measures:
- To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To compare the ppGlucmax for all treatments, the ppTGluc-max, the AUCGluc 0-180 and the AUCGluc 0-360, CGluc-baseline for all treatments. [ Time Frame: 8 hours ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | June 2006 |
| Study Completion Date: | January 2008 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 19 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Established diagnosis of type 1 diabetes for not less than 5 years
- HbA1c values of not more than 9%
- Age: 19 to 70 years
- Sex: Male or Female
- Body Mass Index: 18 - 28 kg/m2
- Informed consent must be obtained in writing for all volunteers.
Exclusion Criteria:
- Type 2 Diabetes mellitus.
- History of hypersensitivity to any of the components in the study medication.
- History of severe or multiple allergies.
- Treatment with any other investigational drug in the last 1 month before study entry.
- Treatment with any concomitant medication that in the judgment of the investigator. would interfere with the study results.
- Progressive disease likely to prove fatal (e.g. malignancies).
- Current drug or alcohol abuse, or a history which in the opinion of the Investigator will impair subject safety or protocol compliance.
- Having a significant cardiovascular, respiratory, gastrointestinal, hepatic, renal, neurological, psychiatric and/or hematological disease as evaluated by the investigator.
- Blood donation within the last 30 days.
- A women who is lactating.
- Pregnant women or women intending to become pregnant during the study.
- A sexually active woman of childbearing age not actively practicing birth control by using a medically accepted device or therapy.
- Positive Serology for HIV, Hepatitis B or Hepatitis C.
- Abnormal ECG, safety lab or physical examination results that are deemed clinically significant by the investigator.
- A lack of compliance or other reasons which, in the opinion of the investigator, prevent the participation of the subject in the study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01000922
Locations
| United States, California | |
| Profil Institute for Clinical Research, Inc. (PICR) | |
| Chula Vista, California, United States, 91911 | |
Sponsors and Collaborators
Biodel
Investigators
| Principal Investigator: | Marcus Hompesch, MD | Profil Institute for Clinical Research, Inc. |
More Information
No publications provided
| Responsible Party: | Biodel |
| ClinicalTrials.gov Identifier: | NCT01000922 History of Changes |
| Other Study ID Numbers: | VIAJECT™-010JM |
| Study First Received: | October 21, 2009 |
| Last Updated: | October 4, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Biodel:
|
Mealtime Insulin Rapid acting insulin Ultra fast VIAject prandial insulin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin LISPRO Glargine |
Insulin Insulin, Long-Acting Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013