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Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01194245
Recruitment Status : Completed
First Posted : September 2, 2010
Results First Posted : August 19, 2014
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 1
Interventions Drug: Insulin lispro
Drug: recombinant human hyaluronidase PH20
Drug: Insulin aspart
Drug: Insulin glulisine
Drug: Insulin glargine
Enrollment 135
Recruitment Details  
Pre-assignment Details The study included an open-label titration period of at least 4 weeks and up to 6 weeks prior to randomization at Week 0.
Arm/Group Title All Enrolled Participants Lispro-PH20 First, Then Insulin Lispro Insulin Lispro First, Then Lispro-PH20 Aspart-PH20 First, Then Insulin Lispro Insulin Lispro First, Then Aspart-PH20
Hide Arm/Group Description

Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.

Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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.

Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

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

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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 (SC), pre-meals, with doses titrated to each participant individually

Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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.

Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

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

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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 (SC), pre-meals, with doses titrated to each participant individually

Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Period Title: Titration Period (4 to 6 Weeks)
Started 135 0 0 0 0
Completed 117 [1] 0 0 0 0
Not Completed 18 0 0 0 0
Reason Not Completed
Withdrawal by Subject             5             0             0             0             0
Physician Decision             3             0             0             0             0
Titration Failure             3             0             0             0             0
Did Not Meet Randomization Criteria             7             0             0             0             0
[1]
Participants that completed the Titration Period were randomized to Treatment Period 1.
Period Title: Treatment Period 1 (Weeks 0 to 12)
Started 0 29 28 30 30
Received at Least 1 Dose of Study Drug 0 29 28 30 30
Completed 0 29 27 29 28
Not Completed 0 0 1 1 2
Reason Not Completed
Lost to Follow-up             0             0             0             0             1
Withdrawal by Subject             0             0             1             1             1
Period Title: Treatment Period 2 (Weeks 12 to 24)
Started 0 29 27 29 28
Completed 0 29 27 29 28
Not Completed 0 0 0 0 0
Arm/Group Title Non-randomized Participants Lispro-PH20 First, Then Insulin Lispro Insulin Lispro First, Then Lispro-PH20 Aspart-PH20 First, Then Insulin Lispro Insulin Lispro First, Then Aspart-PH20 Total
Hide Arm/Group Description

Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized.

Following a titration period of 4 to 6 weeks, 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.

Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

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

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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 (SC), pre-meals, with doses titrated to each participant individually

Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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.

Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

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

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Following a titration period of 4 to 6 weeks, 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 (SC), pre-meals, with doses titrated to each participant individually

Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually

Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Total of all reporting groups
Overall Number of Baseline Participants 18 29 28 30 30 135
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 29 participants 28 participants 30 participants 30 participants 135 participants
34.8  (11.71) 44.6  (14.56) 45.7  (14.94) 42.8  (14.13) 42.5  (14.70) 42.6  (14.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 29 participants 28 participants 30 participants 30 participants 135 participants
Female
6
  33.3%
13
  44.8%
13
  46.4%
14
  46.7%
15
  50.0%
61
  45.2%
Male
12
  66.7%
16
  55.2%
15
  53.6%
16
  53.3%
15
  50.0%
74
  54.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 29 participants 28 participants 30 participants 30 participants 135 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   5.6%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   3.6%
0
   0.0%
2
   6.7%
3
   2.2%
White
17
  94.4%
27
  93.1%
27
  96.4%
30
 100.0%
28
  93.3%
129
  95.6%
More than one race
0
   0.0%
2
   6.9%
0
   0.0%
0
   0.0%
0
   0.0%
2
   1.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 29 participants 28 participants 30 participants 30 participants 135 participants
Hispanic or Latino
4
  22.2%
1
   3.4%
2
   7.1%
2
   6.7%
1
   3.3%
10
   7.4%
Not Hispanic or Latino
14
  77.8%
28
  96.6%
26
  92.9%
28
  93.3%
29
  96.7%
125
  92.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants 29 participants 28 participants 30 participants 30 participants 135 participants
18 29 28 30 30 135
1.Primary Outcome
Title Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period
Hide Description Glycosylated hemoglobin A1C (HBA1c) levels were measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data are presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). Least Squares (LS) means were calculated from mixed effects linear models with treatment (Lispro, Aspart), recombinant human hyaluronidase PH20 (rHuPH20; yes, no), and treatment sequence as fixed effects and participant within treatment sequence as a random effect.
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data.
Arm/Group Title Analog-PH20 Insulin Lispro
Hide Arm/Group Description:
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
Overall Number of Participants Analyzed 111 110
Mean (Standard Deviation)
Unit of Measure: percentage of hemoglobin A1C
-0.14  (0.415) -0.19  (0.440)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Analog-PH20, Insulin Lispro
Comments Approximately 110 participants were to be enrolled, allowing approximately 88 participants to complete both treatment periods (44 for each investigational drug). Assuming a dropout rate of no more than 20%, intra-participant correlation of 0.80, standard deviation of 1.2, and a true difference of 0, the study would have a greater than 90% power to show that Analog-PH20 was non-inferior to insulin lispro alone with respect to the change from baseline in A1C at the end of each treatment period.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority would be supported if the upper limit of the two-sided 95% confidence interval for the difference between Analog-PH20 and the comparator (insulin lispro) did not exceed 0.40.
Statistical Test of Hypothesis P-Value 0.2878
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Means Difference
Estimated Value 0.05
Confidence Interval (2-Sided) 95%
-0.05 to 0.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Daily Insulin Dose
Hide Description Prandial insulin doses were recorded during 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). The mean daily insulin dose over the 3 days during each treatment period is presented. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
Time Frame Week 10 and Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data.
Arm/Group Title Analog-PH20 Insulin Lispro
Hide Arm/Group Description:
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
Overall Number of Participants Analyzed 102 105
Mean (Standard Deviation)
Unit of Measure: units (U)
54.28  (27.071) 56.05  (27.243)
3.Secondary Outcome
Title Percentage of Participants Meeting Glucose Targets
Hide Description Participants were instructed to monitor their blood glucose levels a minimum of 4 times per day on all non-10-point glucose monitoring days. The number of participants meeting 90-minute postprandial plasma glucose (PPG) targets of <140 and <180 milligrams per deciliter (mg/dL) for at least 2/3 of values during non-10-point glucose monitoring days was recorded. The percentage was calculated by dividing the number of participants with values meeting the specified target at least 2/3 of the time by the total number of participants analyzed, multiplied by 100. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
Time Frame Baseline through Week 24, excluding 10-point glucose monitoring days
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data.
Arm/Group Title Analog-PH20 Insulin Lispro
Hide Arm/Group Description:
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
Overall Number of Participants Analyzed 113 113
Measure Type: Number
Unit of Measure: percentage of participants
PPG <140 mg/dL for all meals Number Analyzed 113 participants 113 participants
15.0 8.8
PPG <140 mg/dL for breakfast Number Analyzed 112 participants 113 participants
21.4 10.6
PPG <180 mg/dL for all meals Number Analyzed 113 participants 113 participants
69.9 59.3
PPG <180 mg/dL for breakfast Number Analyzed 112 participants 113 participants
70.5 54.0
4.Secondary Outcome
Title Rates of Hypoglycemia at the End of Each Treatment Period
Hide Description Overall rates of hypoglycemia (blood glucose ≤70 milligrams per deciliter [mg/dL] and <56 mg/dL) were calculated based on 4 weeks of observation for each treatment period. Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time Frame Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both Treatment Period 1 and Treatment Period 2.
Arm/Group Title Analog-PH20 Insulin Lispro
Hide Arm/Group Description:
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
Overall Number of Participants Analyzed 113 113
Measure Type: Number
Unit of Measure: events per participant per month
≤70 mg/dL Number Analyzed 113 participants 113 participants
18.96 19.91
<56 mg/dL Number Analyzed 112 participants 112 participants
7.50 8.05
5.Secondary Outcome
Title Change From Baseline in Body Weight at the End of Each Treatment Period
Hide Description Body weight was measured at baseline (Week 0) and at the end of each treatment period (Week 12 and Week 24). Data is presented by combined treatment group (Lispro-PH20 + Aspart-PH20 = Analog-PH20) and combined comparator drug (Insulin Lispro from both cohorts).
Time Frame Baseline, Week 12 and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data.
Arm/Group Title Analog-PH20 Insulin Lispro
Hide Arm/Group Description:
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
Overall Number of Participants Analyzed 113 113
Mean (Standard Deviation)
Unit of Measure: pounds (lbs)
-0.25  (5.702) 0.10  (4.601)
6.Secondary Outcome
Title Mean Daily Postprandial Glucose (PPG) Excursions
Hide Description Participants performed 10-point glucose monitoring for a total of 3 days during each treatment period (3 days during Week 10 of Treatment Period 1 and 3 days during Week 22 of Treatment Period 2). Mean daily postprandial plasma glucose (PPG) excursions (referring to the change in blood glucose levels from before to after a meal) during 10-point glucose monitoring for breakfast, lunch, and dinner are presented. Data were collected 1 and 2 hours (hr) after each meal for 3 days and the means of each excursion are presented.
Time Frame Week 10 and Week 22
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data.
Arm/Group Title Analog-PH20 Insulin Lispro
Hide Arm/Group Description:
100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
Overall Number of Participants Analyzed 102 106
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter (mg/dL)
1-hr breakfast excursion Number Analyzed 102 participants 105 participants
18.85  (48.348) 27.46  (43.938)
2-hr breakfast excursion Number Analyzed 101 participants 106 participants
-5.63  (52.657) 7.08  (56.997)
1-hr lunch excursion Number Analyzed 100 participants 104 participants
16.26  (46.524) 26.25  (39.070)
2-hr lunch excursion Number Analyzed 101 participants 104 participants
10.68  (53.787) 20.77  (47.005)
1-hr dinner excursion Number Analyzed 102 participants 106 participants
-0.31  (41.368) 4.47  (52.986)
2-hr dinner excursion Number Analyzed 102 participants 106 participants
-5.13  (46.956) -5.16  (54.309)
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse event data were collected in the Intent-to-Treat (ITT) analysis set, defined as all participants who received at least one injection of study drug during a treatment period and had any efficacy endpoint data collected.
 
Arm/Group Title Titration Period (All Enrolled Participants) Lispro-PH20 Treatment Period Insulin Lispro (Lispro-PH20 Cohort) Treatment Period Aspart-PH20 Treatment Period Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
Hide Arm/Group Description

Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.

Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Participants were randomized to the Lispro-PH20 cohort.

100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

Participants were randomized to the Aspart-PH20 cohort.

100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually

Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.

All-Cause Mortality
Titration Period (All Enrolled Participants) Lispro-PH20 Treatment Period Insulin Lispro (Lispro-PH20 Cohort) Treatment Period Aspart-PH20 Treatment Period Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Titration Period (All Enrolled Participants) Lispro-PH20 Treatment Period Insulin Lispro (Lispro-PH20 Cohort) Treatment Period Aspart-PH20 Treatment Period Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/135 (1.48%)   0/56 (0.00%)   1/57 (1.75%)   0/58 (0.00%)   1/59 (1.69%) 
Cardiac disorders           
Pericarditis  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Metabolism and nutrition disorders           
Hypoglycaemia  1  1/135 (0.74%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  1/59 (1.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Titration Period (All Enrolled Participants) Lispro-PH20 Treatment Period Insulin Lispro (Lispro-PH20 Cohort) Treatment Period Aspart-PH20 Treatment Period Insulin Lispro (Aspart-PH20 Cohort) Treatment Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   48/135 (35.56%)   34/56 (60.71%)   29/57 (50.88%)   27/58 (46.55%)   30/59 (50.85%) 
Blood and lymphatic system disorders           
Anaemia  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Cardiac disorders           
Bradycardia  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Palpitations  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Pericarditis  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Ear and labyrinth disorders           
Ear pain  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Endocrine disorders           
Goitre  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Eye disorders           
Astigmatism  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Conjunctivitis allergic  1  0/135 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Gastrointestinal disorders           
Abdominal discomfort  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Abdominal pain upper  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Constipation  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Diarrhoea  1  3/135 (2.22%)  2/56 (3.57%)  1/57 (1.75%)  1/58 (1.72%)  0/59 (0.00%) 
Dysphagia  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Food poisoning  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Irritable bowel syndrome  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Nausea  1  2/135 (1.48%)  1/56 (1.79%)  0/57 (0.00%)  1/58 (1.72%)  3/59 (5.08%) 
Oesophageal obstruction  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Oesophageal spasm  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Oral pain  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Stomatitis  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Toothache  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Vomiting  1  2/135 (1.48%)  1/56 (1.79%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
General disorders           
Asthenia  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Chest discomfort  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Chills  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Fatigue  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Influenza like illness  1  2/135 (1.48%)  2/56 (3.57%)  2/57 (3.51%)  0/58 (0.00%)  1/59 (1.69%) 
Injection site erythema  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Injection site haematoma  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Injection site pain  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Injection site pruritus  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Injection site rash  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Injection site urticaria  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Non-cardiac chest pain  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Oedema peripheral  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Pain  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Pyrexia  1  2/135 (1.48%)  1/56 (1.79%)  3/57 (5.26%)  0/58 (0.00%)  0/59 (0.00%) 
Immune system disorders           
Allergy to animal  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Infections and infestations           
Bronchitis  1  0/135 (0.00%)  2/56 (3.57%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Candidiasis  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Conjunctivitis infective  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Cystitis  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Ear infection  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Fungal infection  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Gastroenteritis  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  1/58 (1.72%)  1/59 (1.69%) 
Gastroenteritis viral  1  1/135 (0.74%)  1/56 (1.79%)  2/57 (3.51%)  2/58 (3.45%)  3/59 (5.08%) 
Gastrointestinal viral infection  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  2/59 (3.39%) 
Herpes zoster  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Influenza  1  3/135 (2.22%)  2/56 (3.57%)  2/57 (3.51%)  1/58 (1.72%)  0/59 (0.00%) 
Injection site infection  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Laryngitis  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Localised infection  1  1/135 (0.74%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Lower respiratory tract infection  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Nasopharyngitis  1  8/135 (5.93%)  8/56 (14.29%)  8/57 (14.04%)  8/58 (13.79%)  6/59 (10.17%) 
Oral herpes  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Pharyngitis  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Pharyngitis streptococcal  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Respiratory tract infection viral  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Sinusitis  1  5/135 (3.70%)  2/56 (3.57%)  3/57 (5.26%)  5/58 (8.62%)  2/59 (3.39%) 
Tinea pedis  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Upper respiratory tract infection  1  8/135 (5.93%)  7/56 (12.50%)  3/57 (5.26%)  2/58 (3.45%)  3/59 (5.08%) 
Urinary tract infection  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  2/58 (3.45%)  0/59 (0.00%) 
Viral infection  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Viral upper respiratory tract infection  1  2/135 (1.48%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Injury, poisoning and procedural complications           
Fall  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Fibula fracture  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Joint sprain  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  1/59 (1.69%) 
Ligament rupture  1  0/135 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/58 (0.00%)  1/59 (1.69%) 
Procedural pain  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Road traffic accident  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Skin laceration  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Stress fracture  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Synovial rupture  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Thermal burn  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Tooth fracture  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Investigations           
Weight increased  1  3/135 (2.22%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Metabolism and nutrition disorders           
Hyperglycaemia  1  0/135 (0.00%)  2/56 (3.57%)  1/57 (1.75%)  0/58 (0.00%)  1/59 (1.69%) 
Hypoglycaemia  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Hypokalaemia  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia  1  1/135 (0.74%)  0/56 (0.00%)  1/57 (1.75%)  1/58 (1.72%)  1/59 (1.69%) 
Back pain  1  2/135 (1.48%)  2/56 (3.57%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Facet joint syndrome  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Intervertebral disc disorder  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Joint swelling  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Musculoskeletal discomfort  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Musculoskeletal pain  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Myalgia  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  1/59 (1.69%) 
Neck pain  1  0/135 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Osteoarthritis  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Pain in extremity  1  2/135 (1.48%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Plantar fasciitis  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Spinal osteoarthritis  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Spondylolisthesis  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Synovial cyst  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Trochanteric syndrome  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Squamous cell carcinoma of skin  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Nervous system disorders           
Diabetic neuropathy  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Dizziness  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Headache  1  2/135 (1.48%)  1/56 (1.79%)  1/57 (1.75%)  4/58 (6.90%)  1/59 (1.69%) 
Lethargy  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Paraesthesia  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Psychiatric disorders           
Anxiety  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Depression  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Stress  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  1/59 (1.69%) 
Renal and urinary disorders           
Dysuria  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Nephrolithiasis  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Nocturia  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Urine flow decreased  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Reproductive system and breast disorders           
Dysmenorrhoea  1  0/61 (0.00%)  0/26 (0.00%)  1/26 (3.85%)  0/28 (0.00%)  0/29 (0.00%) 
Gynaecomastia  1  0/61 (0.00%)  0/26 (0.00%)  0/26 (0.00%)  0/28 (0.00%)  1/29 (3.45%) 
Respiratory, thoracic and mediastinal disorders           
Asthma  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Cough  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  3/58 (5.17%)  0/59 (0.00%) 
Nasal congestion  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  1/59 (1.69%) 
Nasal polyps  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Oropharyngeal pain  1  2/135 (1.48%)  0/56 (0.00%)  1/57 (1.75%)  1/58 (1.72%)  0/59 (0.00%) 
Paranasal sinus hypersecretion  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Productive cough  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Respiratory tract congestion  1  0/135 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Rhinitis allergic  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Rhinitis seasonal  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Sinus congestion  1  1/135 (0.74%)  1/56 (1.79%)  2/57 (3.51%)  1/58 (1.72%)  1/59 (1.69%) 
Upper respiratory tract congestion  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Skin and subcutaneous tissue disorders           
Alopecia  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Dermatitis  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Dermatitis allergic  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  1/59 (1.69%) 
Dry skin  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Eczema asteatotic  1  0/135 (0.00%)  0/56 (0.00%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Hyperhidrosis  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Hyperkeratosis  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Rash  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Skin discolouration  1  0/135 (0.00%)  1/56 (1.79%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Stasis dermatitis  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  1/58 (1.72%)  0/59 (0.00%) 
Urticaria  1  0/135 (0.00%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  1/59 (1.69%) 
Social circumstances           
Stress at work  1  0/135 (0.00%)  1/56 (1.79%)  1/57 (1.75%)  0/58 (0.00%)  0/59 (0.00%) 
Vascular disorders           
Hypertension  1  1/135 (0.74%)  0/56 (0.00%)  0/57 (0.00%)  0/58 (0.00%)  0/59 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12.0
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.
All information obtained as a result of this study or during the conduct of this study will be regarded as confidential. The Investigator agrees to use the information for the purpose of carrying out this study and for no other purpose, unless written permission from the sponsor (Halozyme) is obtained.
Results Point of Contact
Name/Title: Vice President, Endocrinology Clinical Development
Organization: Halozyme Therapeutics, Inc.
Phone: 858-794-8889
Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01194245     History of Changes
Other Study ID Numbers: HALO-117-205
First Submitted: August 31, 2010
First Posted: September 2, 2010
Results First Submitted: August 1, 2014
Results First Posted: August 19, 2014
Last Update Posted: February 26, 2019