Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Halozyme Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00883558
First received: April 15, 2009
Last updated: June 22, 2010
Last verified: June 2010
  Purpose

Insulin lispro is approved by the FDA 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 combined with regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Biological: Insulin lispro injection
Biological: INSULIN-PH20
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • To test for non-inferiority of INSULIN-PH20 NP as compared to insulin lispro with respect to 8-point glucose profiles over 3 days during the second to last week of each treatment cycle, with specific reference to glycemic excursions. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: May 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment 1
INSULIN-PH20 NP
Biological: Insulin lispro injection
U 100 insulin lispro injection, titrated to each individual patient's glycemic control needs.
Biological: INSULIN-PH20
Regular human insulin coformulated with rHuPH20, titrated to each individual patient's glycemic control needs.
Active Comparator: Treatment 2
Insulin lispro
Biological: Insulin lispro injection
U 100 insulin lispro injection, titrated to each individual patient's glycemic control needs.
Biological: INSULIN-PH20
Regular human insulin coformulated with rHuPH20, titrated to each individual patient's glycemic control needs.

Detailed Description:

The purpose of this study is to compare the safety of INSULIN-PH20 NP vs. insulin lispro alone. The safety and tolerability of INSULIN-PH20 will be studied and compared to insulin lispro. The study drugs will be administered by subcutaneous (under the skin) injection.

  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 (per WHO criteria) treated with insulin for ≥24 months.
  • Patients who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening.
  • BMI 18.0 to 35.0 kg/m², inclusive.
  • HbA1c (glycosylated hemoglobin A1c) ≤7.5 % based on central laboratory screening results.
  • Fasting C-peptide <0.6 ng/mL.
  • Patient 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 study.
  • Previous enrollment in this study. Patients who fail the Screening visit may attempt to rescreen into the study.
  • A patient who has proliferative retinopathy or maculopathy, and/or severe neuropathy, in particular autonomic neuropathy, as judged by the Investigator.
  • As judged by the Investigator, clinically significant active disease of the gastrointestinal, cardiovascular (including a history of arrhythmia or conduction delays on ECG), hepatic, neurological, renal, genitourinary, or hematological systems.
  • As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg after 5 minutes in the supine position). Three attempts may be performed to measure blood pressure.
  • History of any illness or disease that in the opinion of the Investigator might confound the results of the study or pose additional risk in administering the study drugs to the patient.
  • As judged by the Investigator, clinically significant findings in routine laboratory data.
  • Use of drugs (such as steroids) that may interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia.
  • Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator.
  • Current addiction to alcohol or substances of abuse as determined by the Investigator.
  • 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 in this study.
  • Receipt of any investigational drug within 4 weeks of Screening.
  • Any condition (intrinsic or extrinsic) that in the judgment of the Investigator will interfere with study participation or evaluation of data. Examples would include: renal insufficiency (serum creatinine >1.5 mg/dL for males or >1.4 mg/dL for females), congestive heart failure required medication treatment, cardiac disease with New York Heart Association Functional Capacity III/IV.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00883558

Locations
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, Florida
Diabetes Research Institute
Miami, Florida, United States, 33136
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, Montana
Mercury Street Medical
Butte, Montana, United States, 59701
United States, North Carolina
UNC Diabetes Care Center/Highgate Specialty Center
Durham, North Carolina, United States, 27713
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Texas
Texas Diabetes and Endocrinology
Austin, Texas, United States, 78731
United States, Washington
West Olympia Internal Medicine
Olympia, Washington, United States, 98502
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Study Director: Douglas Muchmore, M.D. Halozyme Therapeutics
  More Information

No publications provided

Responsible Party: Douglas Muchmore, M.D., Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00883558     History of Changes
Other Study ID Numbers: HALO-117-203
Study First Received: April 15, 2009
Last Updated: June 22, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
recombinant human hyaluronidase (rHuPH20)
Insulin lispro
regular human insulin

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 29, 2014