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Trial record 35 of 447 for:    subcutaneous | "Diabetes Mellitus, Insulin-Dependent"

Randomized, Double-blind, Crossover, Pharmacokinetic (PK) and Glucodynamic (GD) Study of Continuous Subcutaneous Insulin Infusion (CSII) in Participants With Type 1 Diabetes Mellitus (T1DM)

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ClinicalTrials.gov Identifier: NCT01275131
Recruitment Status : Completed
First Posted : January 12, 2011
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition Type 1 Diabetes Mellitus
Interventions Drug: Insulin aspart
Drug: Recombinant human hyaluronidase PH20 (rHuPH20)
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20 Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20 Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart
Hide Arm/Group Description

Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.

After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.

Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.

After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.

Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.

After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp .

After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.

Period Title: Period 1
Started 11 9 13 12
Received at Least One Dose of Study Drug 11 9 13 12
Completed 9 9 10 10
Not Completed 2 0 3 2
Reason Not Completed
Withdrawal by Subject             1             0             3             2
Physician Decision             1             0             0             0
Period Title: 5- to 14-Day Washout Period
Started 9 9 10 10
Completed 9 9 10 10
Not Completed 0 0 0 0
Period Title: Period 2 (Crossover)
Started 9 9 10 10
Completed 8 8 9 8
Not Completed 1 1 1 2
Reason Not Completed
Adverse Event             0             1             0             0
Withdrawal by Subject             1             0             1             2
Arm/Group Title Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20 Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20 Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart Total
Hide Arm/Group Description

Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.

After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.

Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.

After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8.

Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.

After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp.

Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp .

After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp.

Total of all reporting groups
Overall Number of Baseline Participants 11 9 13 12 45
Hide Baseline Analysis Population Description
All participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 9 participants 13 participants 12 participants 45 participants
31.3  (6.39) 44.6  (9.00) 35.5  (9.50) 32.3  (10.29) 35.44  (9.95)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 13 participants 12 participants 45 participants
Female
6
  54.5%
3
  33.3%
7
  53.8%
6
  50.0%
22
  48.9%
Male
5
  45.5%
6
  66.7%
6
  46.2%
6
  50.0%
23
  51.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 13 participants 12 participants 45 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
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
   7.7%
1
   8.3%
2
   4.4%
White
11
 100.0%
9
 100.0%
11
  84.6%
11
  91.7%
42
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
   7.7%
0
   0.0%
1
   2.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 9 participants 13 participants 12 participants 45 participants
Hispanic or Latino
1
   9.1%
1
  11.1%
0
   0.0%
0
   0.0%
2
   4.4%
Not Hispanic or Latino
10
  90.9%
8
  88.9%
13
 100.0%
12
 100.0%
43
  95.6%
Unknown or Not Reported
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 11 participants 9 participants 13 participants 12 participants 45 participants
11 9 13 12 45
1.Primary Outcome
Title Early Insulin Exposure (%AUC[0-60]), Stage 1
Hide Description Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}]) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.
Time Frame 10 minutes predose up to 60 minutes postdose
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all study periods within a given stage with evaluable early insulin exposure (%AUC[0-60]) data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Percentage of AUC(0-360)
Stage 1, Day 2/6 20.99  (6.37) 34.94  (9.48)
Stage 1, Day 4/8 32.83  (14.66) 50.97  (13.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stage 1: Insulin Aspart Alone, Stage 1: Insulin Aspart-rHuPH20
Comments Comparison at Stage 1, Day 2/6
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0009
Comments [Not Specified]
Method Mixed Models Analysis
Comments A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 13.95
Confidence Interval (2-Sided) 90%
7.37 to 20.54
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stage 1: Insulin Aspart Alone, Stage 1: Insulin Aspart-rHuPH20
Comments Comparison at Stage 1, Day 4/8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments A mixed model with fixed effects for treatment, day, and interaction of treatment with day was performed using a compound symmetric covariance matrix.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 18.14
Confidence Interval (2-Sided) 90%
11.55 to 24.72
Estimation Comments [Not Specified]
2.Primary Outcome
Title Early Exposure to Insulin (%AUC[0-60]), Stage 3
Hide Description Early insulin exposure, defined as the percentage of total insulin exposure (area under the insulin concentration curve [AUC{0-360}) that occurs within the first hour following bolus dose of insulin during the 2 euglycemic clamps is presented. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 120, 150, 180, 240, 300, and 360 minutes postdose during the euglycemic clamp.
Time Frame 10 minutes predose up to 60 minutes postdose on Days 2/7, 3/8, and 5/10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable %AUC(0-60) data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Percentage of AUC(0-360)
Stage 3, Day 2/7 15.70  (6.38) 32.11  (10.91)
Stage 3, Day 3/8 22.29  (5.43) 36.39  (9.43)
Stage 3, Day 5/10 27.31  (10.49) 32.64  (11.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Stage 3: Insulin Aspart Alone, Stage 3: Insulin Aspart + rHuPH20
Comments Comparison at Stage 3, Day 2/7
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 16.41
Confidence Interval (2-Sided) 90%
11.86 to 20.97
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Stage 3: Insulin Aspart Alone, Stage 3: Insulin Aspart + rHuPH20
Comments Comparison at Stage 3, Day 3/8
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 14.10
Confidence Interval (2-Sided) 90%
9.55 to 18.65
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Stage 3: Insulin Aspart Alone, Stage 3: Insulin Aspart + rHuPH20
Comments Comparison at Stage 3, Day 5/10
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0552
Comments [Not Specified]
Method Mixed Models Analysis
Comments Mixed model with fixed effects for treatment, day, and interaction of treatment with day. A compound symmetric covariance matrix was assumed.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 5.32
Confidence Interval (2-Sided) 90%
0.77 to 9.88
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Maximum Glucose Infusion Rate (GIRmax), Stage 1
Hide Description Maximum glucose infusion rates (GIRmax) for Stage1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Day 2/6 and Day 4/8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable GIRmax data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Milligrams/kilogram/minute
Stage 1, Day 2/6 13.37  (4.23) 12.51  (3.19)
Stage 1, Day 4/8 11.88  (3.64) 11.52  (3.67)
4.Secondary Outcome
Title Maximum Glucose Infusion Rate (GIRmax), Stage 3
Hide Description Maximum glucose infusion rates (GIRmax) for Stage 3 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable GIRmax data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Milligrams/kilogram/minute
Stage 3, Day 2/7 9.58  (2.28) 12.63  (3.88)
Stage 3, Day 3/8 10.07  (3.36) 12.4  (3.39)
Stage 3, Day 5/10 9.97  (3.53) 10.76  (3.35)
5.Secondary Outcome
Title Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 1
Hide Description Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 1 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Day 2/6 and Day 4/8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable tGIRmax data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Minutes
Stage 1, Day 2/6 115.38  (59.21) 102.38  (38.28)
Stage 1, Day 4/8 92.50  (24.71) 84.31  (25.89)
6.Secondary Outcome
Title Time to First Occurrence of Maximum Glucose Infusion Rate (tGIRmax), Stage 3
Hide Description Time to first occurrence of maximum glucose infusion rate (tGIRmax) for Stage 3 is presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable tGIRmax data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Minutes
Stage 3, Day 2/7 127.65  (60.02) 78.53  (27.04)
Stage 3, Day 3/8 135.24  (73.00) 79.47  (42.57)
Stage 3, Day 5/10 117.76  (75.20) 79.53  (42.99)
7.Secondary Outcome
Title Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 1
Hide Description Early and late times to 50% maximum glucose infusion rate (tGIR50%max) for Stage 1 are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on day 2/6 and Day 4/8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable early or late tGIR50%max data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Minutes
Early tGIR50%max, Stage 1, Day 2/6 46.50  (18.08) 34.88  (17.92)
Late tGIR50%max, Stage 1, Day 2/6 162.19  (56.78) 158.06  (52.58)
Early tGIR50%max, Stage 1, Day 4/8 35.19  (28.54) 39.75  (18.71)
Late tGIR50%max, Stage 1, Day 4/8 132.63  (47.37) 114.19  (29.05)
8.Secondary Outcome
Title Time to 50% Maximum Glucose Infusion Rate (tGIR50%Max), Stage 3
Hide Description Early and late time to 50% maximum glucose infusion rates (tGIR50%max) for Stage 3 studies are presented. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10
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Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable early and late tGIR50%max data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Minutes
Early tGIR50%max, Stage 3, Day 2/7 58.47  (17.53) 31.06  (20.73)
Late tGIR50%max, Stage 3, Day 2/7 144.18  (61.44) 98.71  (39.87)
Early tGIR50%max, Stage 3, Day 3/8 32.59  (22.88) 31.53  (21.27)
Late tGIR50%max, Stage 3, Day 3/8 153.41  (65.35) 102.88  (44.57)
Early tGIR50%max, Stage 3, Day 5/10 27.29  (18.40) 28.88  (21.97)
Late tGIR50%max, Stage 3, Day 5/10 136.88  (73.39) 110.59  (55.10)
9.Secondary Outcome
Title Time to 50% Total Glucose Infused (50%Gtot), Stage 1
Hide Description Time to 50% total glucose infused (50%Gtot) is presented for Stage 1. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Day 2/6 and Day 4/8
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Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Minutes
Stage 1, Day 2/6 156.13  (18.70) 134.94  (18.28)
Stage 1, Day 4/8 137.38  (22.21) 115.25  (14.50)
10.Secondary Outcome
Title Time to 50% Total Glucose Infused (50%Gtot), Stage 3
Hide Description Time to 50% of total glucose infused (50%Gtot) is presented for Stage 3. Blood samples were collected at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 0 up to 360 minutes postdose on Days 2/7, 3/8, and 5/10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable 50%Gtot data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Minutes
Stage 3, Day 2/7 174.59  (25.86) 124.18  (22.03)
Stage 3, Day 3/8 154.06  (24.02) 120.00  (17.12)
Stage 3, Day 5/10 146.59  (28.63) 130.18  (23.54)
11.Secondary Outcome
Title Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 1
Hide Description Area under the glucose concentration curve for 0 to 360 minutes (AUC[0-360]) from Stage 1 is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 30 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8
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Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Picomoles*minutes/liter
Stage 1, Day 2/6 1978.08  (631.89) 1977.02  (795.79)
Stage 1, Day 4/8 1598.40  (546.00) 1324.31  (500.04)
12.Secondary Outcome
Title Area Under the Glucose Concentration Curve (AUC[0-360]), Stage 3
Hide Description Area under the glucose concentration curve from 0 to 360 minutes (AUC[0-360]) for Stage 3 studies is presented. Blood samples were collected 30 and 10 minutes prior to insulin bolus and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 30 minutes predose up to 360 minutes postdose Days 2/7, 3/8, and 5/10
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Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable AUC(0-360) data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: Picomoles*minutes/liter
Stage 3, Day 2/7 1197.60  (385.44) 1509.38  (541.45)
Stage 3, Day 3/8 1368.81  (424.16) 1405.75  (516.85)
Stage 3, Day 5/10 1289.22  (486.03) 1369.97  (462.78)
13.Secondary Outcome
Title Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 1
Hide Description Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 1. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 10 minutes predose up to 360 minutes postdose on Day 2/6 and Day 4/8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.
Arm/Group Title Stage 1: Insulin Aspart Alone Stage 1: Insulin Aspart-rHuPH20
Hide Arm/Group Description:
Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
Overall Number of Participants Analyzed 16 16
Mean (Standard Deviation)
Unit of Measure: Ratio
Stage 1, Day 2/6 163.63  (14.70) 146.51  (16.30)
Stage 1, Day 4/8 147.50  (23.86) 132.60  (15.55)
14.Secondary Outcome
Title Duration of Insulin Action (AUMC[0-360]/AUC[0-360]), Stage 3
Hide Description Duration of insulin action was calculated by dividing the area under the first moment curve (AUMC[0-360]) by the area under the concentration versus time curve (AUC[0-360]) for Stage 3. Blood samples were collected 10 minutes predose and at 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 150, 180, 240, 300, and 360 minutes postdose during a euglycemic clamp.
Time Frame 10 minutes predose up to 360 minutes postdose on Days 2/7, 3/8, and 5/10
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who completed all periods of study within a given stage with evaluable AUMC(0-360)/AUC(0-360) data.
Arm/Group Title Stage 3: Insulin Aspart Alone Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description:
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
Overall Number of Participants Analyzed 17 17
Mean (Standard Deviation)
Unit of Measure: ratio
Stage 3, Day 2/7 180.39  (18.72) 138.59  (18.41)
Stage 3, Day 3/8 164.65  (19.97) 135.71  (17.30)
Stage 3, Day 5/10 156.14  (26.38) 145.81  (16.42)
Time Frame [Not Specified]
Adverse Event Reporting Description AEs were classified by the body system affected.
 
Arm/Group Title Stage 1: Insulin Aspart Stage 1: Insulin Aspart-rHuPH20 Stage 3: Insulin Aspart Stage 3: Insulin Aspart + rHuPH20
Hide Arm/Group Description Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2. Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2. Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp. Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
All-Cause Mortality
Stage 1: Insulin Aspart Stage 1: Insulin Aspart-rHuPH20 Stage 3: Insulin Aspart Stage 3: Insulin Aspart + rHuPH20
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Stage 1: Insulin Aspart Stage 1: Insulin Aspart-rHuPH20 Stage 3: Insulin Aspart Stage 3: Insulin Aspart + rHuPH20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/18 (0.00%)      0/23 (0.00%)      0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Stage 1: Insulin Aspart Stage 1: Insulin Aspart-rHuPH20 Stage 3: Insulin Aspart Stage 3: Insulin Aspart + rHuPH20
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/20 (80.00%)      13/18 (72.22%)      14/23 (60.87%)      12/22 (54.55%)    
Blood and lymphatic system disorders         
Anaemia  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 2/22 (9.09%)  2
Eye disorders         
Retinal haemorrhage  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Gastrointestinal disorders         
Nausea  1  1/20 (5.00%)  1 1/18 (5.56%)  1 0/23 (0.00%)  0 2/22 (9.09%)  2
Abdominal pain  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Diarrhoea  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Dyspepsia  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
General disorders         
Injection site erythema  1  2/20 (10.00%)  2 2/18 (11.11%)  2 0/23 (0.00%)  0 0/22 (0.00%)  0
Infusion site pain  1  0/20 (0.00%)  0 2/18 (11.11%)  2 1/23 (4.35%)  1 1/22 (4.55%)  1
Injection site haemorrhage  1  0/20 (0.00%)  0 2/18 (11.11%)  2 0/23 (0.00%)  0 1/22 (4.55%)  1
Injection site pruritus  1  2/20 (10.00%)  4 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Asthenia  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Fatigue  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Infusion site extravasation  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 2/22 (9.09%)  2
Infusion site haemorrhage  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 1/22 (4.55%)  1
Infusion site oedema  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Injection site inflammation  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Injection site oedema  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Oedema peripheral  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 1/22 (4.55%)  1
Vessel puncture site swelling  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 1/22 (4.55%)  2
Injection site pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 1/22 (4.55%)  1
Infusion site haematoma  1  2/20 (10.00%)  2 1/18 (5.56%)  1 0/23 (0.00%)  0 1/22 (4.55%)  1
Infusion site irritation  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Infusion site pruritus  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Infusion site thrombosis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Vessel puncture site pain  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Infections and infestations         
Infusion site infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 1/22 (4.55%)  1
Fungal infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Hordeolum  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Infusion site cellulitis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Vaginal infection  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Injury, poisoning and procedural complications         
Incision site haemorrhage  1  3/20 (15.00%)  3 3/18 (16.67%)  3 0/23 (0.00%)  0 0/22 (0.00%)  0
Incision site erythema  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Burns first degree  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Infusion related reaction  1  0/20 (0.00%)  0 1/18 (5.56%)  1 0/23 (0.00%)  0 0/22 (0.00%)  0
Metabolism and nutrition disorders         
Hypokalemia  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders         
Neck pain  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Pain in extremity  1  0/20 (0.00%)  0 0/18 (0.00%)  0 2/23 (8.70%)  2 0/22 (0.00%)  0
Nervous system disorders         
Headache  1  7/20 (35.00%)  7 3/18 (16.67%)  3 4/23 (17.39%)  5 3/22 (13.64%)  3
Dizziness  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Tremor  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Nasal congestion  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pruritus  1  1/20 (5.00%)  1 0/18 (0.00%)  0 0/23 (0.00%)  0 0/22 (0.00%)  0
Dry skin  1  0/20 (0.00%)  0 0/18 (0.00%)  0 0/23 (0.00%)  0 1/22 (4.55%)  1
Ecchymosis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Hyperhidrosis  1  0/20 (0.00%)  0 0/18 (0.00%)  0 1/23 (4.35%)  1 0/22 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (14.0)
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.
 
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: NCT01275131     History of Changes
Other Study ID Numbers: HALO-117-105
First Submitted: January 10, 2011
First Posted: January 12, 2011
Results First Submitted: June 26, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014