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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00883558
First received: April 15, 2009
Last updated: August 28, 2014
Last verified: August 2014

April 15, 2009
August 28, 2014
May 2009
February 2010   (final data collection date for primary outcome measure)
Postprandial Glucose Excursion [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
A 2-hour postprandial glucose excursion was measured for 3 meals over 3 days during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle). For each of the 3 days, the mealtime (breakfast, lunch, and dinner) excursions were calculated as the post-meal glucose value minus the pre-meal value as determined by 8-point glucose monitoring. The average of all excursions over the 3 days for the corresponding treatment cycle is presented.
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 ]
Complete list of historical versions of study NCT00883558 on ClinicalTrials.gov Archive Site
  • Time Spent With Blood Glucose Value Outside a 71-139 Milligrams Per Deciliter (mg/dL) Range During Continuous Glucose Monitoring [ Time Frame: Week 14 and Week 26 ] [ Designated as safety issue: No ]
    Participants were provided a continuous glucose monitoring (CGM) device, consisting of a sensor, transmitter, and receiver. Total time the participant's blood glucose was outside the 71-139 mg/dL range during 3 days of CGM during each treatment cycle (3 days during Week 14 of the first treatment cycle and 3 days during Week 26 of the second treatment cycle) is presented.
  • Number of Participants With Hypoglycemic Events [ Time Frame: Baseline through Week 29 ] [ Designated as safety issue: Yes ]
    The number of participants with at least one hypoglycemic event (HE) reported during the entire study is presented. Additionally, the number of participants with severe HEs (those that necessitated administration of carbohydrate or glucagon, or resuscitation, by another person) is also presented. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
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Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
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

Insulin lispro is approved by the Food and Drug Administration (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 a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.

The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus insulin lispro alone.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Diabetes Mellitus, Type 1
  • Drug: Insulin Lispro
    Other Name: Humalog
  • Drug: regular human insulin
    Other Name: Humulin R
  • Drug: recombinant human hyaluronidase PH20
    Other Names:
    • Hylenex
    • rHuPH20
    • PH20
  • Drug: Insulin glargine
    Other Name: Lantus
Experimental: INSULIN-PH20 NP / Insulin Lispro

All enrolled participants underwent a 1-month dose titration period and received 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC) pre-meals, with doses titrated to each participant individually.

Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.

INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.

Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump.

Interventions:
  • Drug: Insulin Lispro
  • Drug: regular human insulin
  • Drug: recombinant human hyaluronidase PH20
  • Drug: Insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
April 2010
February 2010   (final data collection date for primary outcome measure)

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.
  • Participants with Type 1 diabetes mellitus (T1DM) (per World Health Organization [WHO] criteria) treated with insulin for ≥24 months.
  • Participants who use an insulin infusion pump for basal insulin administration must be on the device for at least 90 days prior to screening.
  • Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m^2), inclusive.
  • Glycosylated hemoglobin A1c (HbA1c) ≤7.5 % based on central laboratory screening results.
  • Fasting C-peptide <0.6 nanograms per milliliter (ng/mL).
  • Participants should be in good general health based on medical history and physical examination and 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. Participants who fail Screening may attempt to rescreen into the study.
  • A participant 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 electrocardiogram [ECG]), hepatic, neurological, renal, genitourinary, or hematological systems.
  • As judged by the Investigator, uncontrolled hypertension (diastolic blood pressure ≥100 millimeters of mercury [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 participant.
  • As judged by the Investigator, clinically significant findings in routine laboratory data.
  • Use of drugs (such as systemic corticosteroids) 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 milligrams per deciliter [mg/dL] for males or >1.4 mg/dL for females), congestive heart failure required medication treatment, and cardiac disease with New York Heart Association (NYHA) Functional Capacity of III/IV.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00883558
HALO-117-203
No
Halozyme Therapeutics
Halozyme Therapeutics
Not Provided
Study Director: Douglas Muchmore, M.D. Halozyme Therapeutics
Halozyme Therapeutics
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP