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
Results First Received: August 28, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Diabetes Mellitus, Type 1
Interventions: Drug: Insulin Lispro
Drug: regular human insulin
Drug: recombinant human hyaluronidase PH20
Drug: Insulin glargine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
All Enrolled Participants

Prior to randomization, all enrolled participants underwent a 1-month dose titration period.

Insulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.

Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump.

INSULIN-PH20 NP First, Then Insulin Lispro

Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.

INSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.

Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.

Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump.

Insulin Lispro First, Then INSULIN-PH20 NP

Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.

Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.

INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.

Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump.


Participant Flow for 3 periods

Period 1:   Titration Period (Weeks 0 to 4)
    All Enrolled Participants     INSULIN-PH20 NP First, Then Insulin Lispro     Insulin Lispro First, Then INSULIN-PH20 NP  
STARTED     48     0     0  
COMPLETED     46     0     0  
NOT COMPLETED     2     0     0  
Withdrawal by Subject                 2                 0                 0  

Period 2:   First Treatment Cycle (Weeks 4 to 16)
    All Enrolled Participants     INSULIN-PH20 NP First, Then Insulin Lispro     Insulin Lispro First, Then INSULIN-PH20 NP  
STARTED     0     22     24  
Received at Least 1 Dose of Study Drug     0     22     24  
COMPLETED     0     19     23  
NOT COMPLETED     0     3     1  
Adverse Event                 0                 1                 0  
Withdrawal by Subject                 0                 1                 1  
Protocol Violation                 0                 1                 0  

Period 3:   Second Treatment Cycle (Weeks 16 to 28)
    All Enrolled Participants     INSULIN-PH20 NP First, Then Insulin Lispro     Insulin Lispro First, Then INSULIN-PH20 NP  
STARTED     0     19     23  
Received at Least 1 Dose of Study Drug     0     19     23  
COMPLETED     0     19     22  
NOT COMPLETED     0     0     1  
Withdrawal by Subject                 0                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Participants who were randomized and received at least 1 dose of study drug.

Reporting Groups
  Description
All Randomized Participants

Following a 1-month titration period, 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.


Baseline Measures
    All Randomized Participants  
Number of Participants  
[units: participants]
  46  
Age  
[units: years]
Mean ± Standard Deviation
  41.6  ± 13.28  
Gender  
[units: participants]
 
Female     22  
Male     24  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     0  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     44  
More than one race     0  
Unknown or Not Reported     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     2  
Not Hispanic or Latino     44  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     46  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Postprandial Glucose Excursion   [ Time Frame: Week 14 and Week 26 ]

2.  Secondary:   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 ]

3.  Secondary:   Number of Participants With Hypoglycemic Events   [ Time Frame: Baseline through Week 29 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Vice President, Endocrinology Clinical Development
Organization: Halozyme Therapeutics, Inc.
phone: 858-794-8889


No publications provided


Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00883558     History of Changes
Other Study ID Numbers: HALO-117-203
Study First Received: April 15, 2009
Results First Received: August 28, 2014
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration