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| Sponsor: | Halozyme Therapeutics |
|---|---|
| Information provided by: | Halozyme Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00774800 |
Purpose
Humalog and Humulin R are FDA approved medications for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 will be co-administered with both Humalog and Humulin R in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Drug: Humalog, Humulin R, rHuPH20 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Phase II Study Evaluating Pharmacokinetics and Postprandial Glycemic Response of Subcutaneously Injected Humalog and Humlin R With/Without Co-Injected Recombinant Human Hyaluronidase Following Liquid Meal in Type1 Diabetes Mellitus Patients |
| Enrollment: | 22 |
| Study Start Date: | October 2008 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1
Humalog with rHuPH20, Humulin R with rHuPH20
|
Drug: Humalog, Humulin R, rHuPH20
Up to 4 injections of Humalog, with or without rHuPH20, and up to 3 injections of Humulin R, with or without rHuPH20.
Other Names:
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Active Comparator: Arm 2 (Crossover)
Humalog or Humulin R
|
Drug: Humalog, Humulin R, rHuPH20
Up to 4 injections of Humalog, with or without rHuPH20, and up to 3 injections of Humulin R, with or without rHuPH20.
Other Names:
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The primary objective is to compare the early insulin exposure as measured by the primary pharmacokinetic (PK) endpoint of AUCINS 0-60 of Humalog and Humulin R injected subcutaneously (SC) before a liquid meal with and without recombinant human hyaluronidase (rHuPH20).
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Profil Institute for Clinical Research, Inc. | |
| Chula Vista, California, United States, 91911 | |
| Principal Investigator: | Linda A Morrow, M.D. | Profil Institute for Clinical Research, Inc. |
More Information
| Responsible Party: | Douglas Muchmore, M.D., Halozyme Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00774800 History of Changes |
| Other Study ID Numbers: | HZ2-08-05 |
| Study First Received: | October 15, 2008 |
| Last Updated: | May 7, 2009 |
| Health Authority: | United States: Food and Drug Administration |
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Recombinant Hyaluronidase Type 1 Diabetes Mellitus Humalog |
Humulin R rHuPH20 Hylenex |
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Insulin LISPRO Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |