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Sponsored by: |
Halozyme Therapeutics |
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Information provided by: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00774800 |
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 |
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Type 1 Diabetes Mellitus |
Drug: Humalog, Humulin R, rHuPH20 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind (Subject), Dose Comparison, Crossover Assignment, Pharmacokinetics Study |
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 |
Estimated Enrollment: | 20 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm 1: Experimental
Humalog with rHuPH20, Humulin R with rHuPH20
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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.
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Arm 2 (Crossover): Active Comparator
Humalog or Humulin R
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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.
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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).
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Profil Institute for Clinical Research, Inc. | Recruiting |
Chula Vista, California, United States, 91911 | |
Contact: Linda Morrow, M.D. 619-427-1300 linda.morrow@profil-research.com | |
Principal Investigator: Linda A Morrow, M.D. |
Principal Investigator: | Linda A Morrow, M.D. | Profil Institute for Clinical Research, Inc. |
Responsible Party: | Halozyme Therapeutics ( Douglas Muchmore, M.D. ) |
Study ID Numbers: | HZ2-08-05 |
Study First Received: | October 15, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00774800 |
Health Authority: | United States: Food and Drug Administration |
Recombinant Hyaluronidase Type 1 Diabetes Mellitus Humalog |
Humulin R rHuPH20 Hylenex |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |