Pharmacokinetic and Glucodynamic Crossover Study of SC Administered Insulin Lispro +rHuPH20 and Regular Human Insulin +rHuPH20 Compared to Insulin Lispro Alone

This study has been completed.
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00862849
First received: March 13, 2009
Last updated: October 1, 2009
Last verified: October 2009
  Purpose

Insulin lispro and regular human insulin 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 insulin lispro and regular human insulin 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
Healthy Volunteers
Drug: Lispro, Regular Human Insulin, rHuPH20
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic 6-Way Crossover Study of SC Administered Insulin Lispro With Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Lispro Alone in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Comparison of variability in PK responses to the test articles. [ Time Frame: Multiple timepoints for 8 hours post injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine various PK parameters for each of the three study treatments based on serum insulin concentrations collected at specified time points. [ Time Frame: Multiple timepoints for 8 hours post injection ] [ Designated as safety issue: Yes ]
  • Determine various GD responses based on glucose infusion rates over time for each of the three study treatments. [ Time Frame: Multiple timepoints for 8 hours post injection ] [ Designated as safety issue: Yes ]
  • Evaluate the safety and local tolerability of the SC injection of insulin lispro + rHuPH20, regular human insulin + rHuPH20, and insulin lispro alone. [ Time Frame: Multiple timepoints for 8 hours post injection ] [ Designated as safety issue: Yes ]

Enrollment: 22
Study Start Date: March 2009
Study Completion Date: August 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Subcutaneously Administered Insulin Lispro With Recombinant Human Hyaluronidase (rHuPH20)
Drug: Lispro, Regular Human Insulin, rHuPH20
Up to 6 injections of study drug
Other Names:
  • Lispro
  • Regular Human Insulin
  • rHuPH20
Experimental: 2
Subcutaneously Administered Regular Human Insulin With Recombinant Human Hyaluronidase (rHuPH20)
Drug: Lispro, Regular Human Insulin, rHuPH20
Up to 6 injections of study drug
Other Names:
  • Lispro
  • Regular Human Insulin
  • rHuPH20
Active Comparator: 3
Subcutaneously Administered Insulin Lispro Alone
Drug: Lispro, Regular Human Insulin, rHuPH20
Up to 6 injections of study drug
Other Names:
  • Lispro
  • Regular Human Insulin
  • rHuPH20

Detailed Description:

The purpose of this study is to compare the pharmacokinetics (absorption, distribution, breakdown and elimination) of regular human insulin + rHuPH20 vs. insulin lispro alone, and to compare the pharmacokinetics of insulin lispro + rHuPH20 vs insulin lispro alone. The effects of regular human insulin + rHuPH20, insulin lispro + rHuPH20, and insulin lispro alone on the body will be evaluated by blood glucose measurements and by calculating the rate at which a glucose solution is infused to maintain blood glucose within a certain range. The safety and tolerability of insulin lispro with and without rHuPH20 and regular human insulin with rHuPH20 will be studied. The study drugs will be administered by subcutaneous (under the skin) injection.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy subjects between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities)
  • BMI between 18-27 kg/m2, inclusive.
  • Total body weight >65 kg (143 lb) for men and >46 kg (101 lb) for women.
  • Decision making capacity and willingness to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including adequate venous access.
  • Vital signs (BP, Pulse Rate, Body Temperature) within normal range or, if out of range, assessed by the Principal Investigator (PI) as not clinically significant (NCS).
  • Fasting blood glucose level < 100 mg/dL at screening.
  • A negative serum pregnancy test (if female of childbearing potential).
  • Female subjects of childbearing potential must agree to be practicing effective birth control or abstinence currently and agree to continue to do so for the duration of their time on study.
  • Signed, written IRB-approved informed consent.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, oncologic, or neurologic (to include history of seizures) disease; hypoglycemic episodes; intercurrent illness (such as influenza); or allergic disease (including severe drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). Clinical significance to be determined by the PI.
  • As judged by the Investigator, clinically significant findings in routine laboratory data. (Anemia with hematocrit less than 33% at screening is specifically exclusionary.)
  • Known history of diabetes mellitus (type 1 or type 2) or gestational diabetes.
  • Known allergy to hyaluronidase or any other ingredient in the study drug.
  • Positive HIV 1 (human immunodeficiency virus) antibody test, hepatitis B (anti-HBsAg) or hepatitis C (anti-HCV) antibody test.
  • History or evidence of alcohol or drug abuse.
  • History or evidence of use of any tobacco or nicotine-containing product within 6 months of screening and a screening qualitative urine nicotine test.
  • Use of drugs that may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action or glucose utilization.
  • Donation of blood in excess of 500 mL within 56 days before dosing.
  • Participation in a study of any investigational drug or device 30 days before enrollment in this study.
  • The subject is unfit for the study in the opinion of the investigator.
  • Women who are pregnant or breast-feeding.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862849

Locations
United States, California
Profil Institute for Clinical Research, Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Principal Investigator: Linda A Morrow, M.D. Profil Institute for Clinical Research, Inc.
  More Information

No publications provided by Halozyme Therapeutics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Douglas Muchmore, M.D., Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00862849     History of Changes
Other Study ID Numbers: HALO-117-103
Study First Received: March 13, 2009
Last Updated: October 1, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
rHuPH20
Recombinant Human Hyaluronidase
Insulin Lispro
Regular Human Insulin

Additional relevant MeSH terms:
Insulin LISPRO
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014