Phase II PK Study With Humalog and Humulin R With and Without rHuPH20 in T1DM

This study has been completed.
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00774800
First received: October 15, 2008
Last updated: May 7, 2009
Last verified: May 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Assess differences between PK and PD properties of two types of insulin (Humalog and Humulin R) when each product is injected SC with and without rHuPH20 following a liquid meal [ Time Frame: Multiple timepoints for 8 hours after each injection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Various other PK and PD endpoint measures [ Time Frame: Multiple timepoints 8 hours post injection ] [ Designated as safety issue: Yes ]
  • AEs, hematology, biochemistry, urinalyses, physical examinations, vital signs, ECGs, blood glucose, local tolerability at injection site, and antibody formation to insulin agents and to rHuPH20 [ Time Frame: Multiple timepoints 8 hours post injection ] [ Designated as safety issue: Yes ]

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:
  • Humalog
  • Humulin R
  • Hylenex
  • rHuPH20
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:
  • Humalog
  • Humulin R
  • Hylenex
  • rHuPH20

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Male or female of age 18 to 65 years, inclusive. Females of child-bearing potential must use a standard and effective means of birth control for the duration of the study.
  • Patients with Type 1 diabetes mellitus treated with insulin for greater than or equal to 12 months.
  • BMI 18.0 to 29.0 kg/m2, inclusive.
  • HbA1c (glycosylated hemoglobin A1C) less than or equal to 10% based on local laboratory results.
  • Fasting C-peptide less than 0.6 ng/mL.
  • Current treatment with insulin less than 1.2 U/kg/day.
  • Patients should be in good general health based on medical history and physical examination, without medical conditions that might prevent the completion of study drug injections and assessments required in this protocol.

Exclusion Criteria:

  • Known or suspected allergy to any component of any of the study drugs in this trial.
  • Previous enrollment in this trial.
  • A patient who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
  • Clinically significant (as judged by the Investigator) active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems, or uncontrolled hypertension (diastolic blood pressure greater than or equal to 100 mmHg and/or systolic blood pressure greater than or equal to 160 mmHg after 5 minutes in the supine position).
  • History of any illness or disease that in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the study drugs to the patient.
  • Clinically significant findings (as judged by the Investigator) in routine laboratory data, including anemia with hemoglobin less than lower limits of normal at screening.
  • Use of drugs which may interfere with the interpretation of trial results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia.
  • Recurrent major hypoglycemia or hypoglycemic unawareness, as judged by the Investigator.
  • Current addiction to alcohol or substances of abuse as determined by the Investigator.
  • Blood donation (> 500 mL) within the previous 9 weeks prior to Visit 2A on study.
  • Pregnancy, breast-feeding, the intention of becoming pregnant, or not using adequate contraceptive measures (adequate contraceptive measures consist of sterilization, intra-uterine device [IUD], oral or injectable contraceptives or barrier methods).
  • Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.
  • Symptomatic gastroparesis.
  • History or evidence of use of any tobacco- or nicotine-containing product within 6 months of screening or screening quantitative urine nicotine concentration >50 ng/mL.
  • Receipt of any investigational drug within 4 weeks of Visit 2A in this study.
  • Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with trial participation or evaluation of data.
  • Current use of insulin pump therapy.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00774800

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: 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

Keywords provided by Halozyme Therapeutics:
Recombinant Hyaluronidase
Type 1 Diabetes Mellitus
Humalog
Humulin R
rHuPH20
Hylenex

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 22, 2014