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Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT01194258
First received: August 31, 2010
Last updated: August 1, 2014
Last verified: August 2014
Results First Received: August 1, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type II
Interventions: Drug: Insulin lispro
Drug: Insulin aspart
Drug: Recombinant human hyaluronidase PH20
Drug: Insulin glulisine
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
The study included an open-label titration period of at least 4 weeks and up to 6 weeks prior to randomization at Week 0.

Reporting Groups
  Description
All Enrolled Participants

Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected 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.

Insulin Lispro, Then Lispro-PH20

Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.

Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study.

Lispro-PH20, Then Insulin Lispro

Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.

Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study.

Insulin Lispro, Then Aspart-PH20

Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.

Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study.

Aspart-PH20, Then Insulin Lispro

Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.

Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study.


Participant Flow for 3 periods

Period 1:   Titration Period
    All Enrolled Participants     Insulin Lispro, Then Lispro-PH20     Lispro-PH20, Then Insulin Lispro     Insulin Lispro, Then Aspart-PH20     Aspart-PH20, Then Insulin Lispro  
STARTED     132     0     0     0     0  
COMPLETED     121     0     0     0     0  
NOT COMPLETED     11     0     0     0     0  
Withdrawal by Subject                 6                 0                 0                 0                 0  
Lost to Follow-up                 2                 0                 0                 0                 0  
Titration failure                 3                 0                 0                 0                 0  

Period 2:   Period 1 (12 Weeks)
    All Enrolled Participants     Insulin Lispro, Then Lispro-PH20     Lispro-PH20, Then Insulin Lispro     Insulin Lispro, Then Aspart-PH20     Aspart-PH20, Then Insulin Lispro  
STARTED     0 [1]   29 [2]   30 [3]   29 [4]   33 [5]
Received at Least 1 Dose of Study Drug     0     29     30     29     33  
COMPLETED     0     29     30     29     32  
NOT COMPLETED     0     0     0     0     1  
Death                 0                 0                 0                 0                 1  
[1] Participants were randomized to the Insulin lispro or an Analog-PH20 group after titration.
[2] After the titration phase, 29 participants were randomized to the Insulin lispro/Lispro-PH20 group.
[3] After the titration phase, 30 participants were randomized to the Lispro-PH20/Insulin lispro group.
[4] After the titration phase, 29 participants were randomized to the Insulin lispro/Aspart-PH20 group.
[5] After the titration phase, 33 participants were randomized to the Aspart-PH20/Insulin lispro group.

Period 3:   Period 2 (12 Weeks)
    All Enrolled Participants     Insulin Lispro, Then Lispro-PH20     Lispro-PH20, Then Insulin Lispro     Insulin Lispro, Then Aspart-PH20     Aspart-PH20, Then Insulin Lispro  
STARTED     0     29     30     29     32  
COMPLETED     0     27     29     29     30  
NOT COMPLETED     0     2     1     0     2  
Lost to Follow-up                 0                 0                 0                 0                 2  
Adverse Event                 0                 1                 0                 0                 0  
Withdrawal by Subject                 0                 1                 1                 0                 0  



  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.
All participants in the study, including those who were enrolled but were not randomized.

Reporting Groups
  Description
All Study Participants All participants in the study, including those who were enrolled but were not randomized.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  132  
Age  
[units: years]
Mean ± Standard Deviation
  58.7  ± 9.85  
Gender  
[units: participants]
 
Female     53  
Male     79  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     1  
Black or African American     10  
White     115  
More than one race     1  
Unknown or Not Reported     2  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     19  
Not Hispanic or Latino     113  
Unknown or Not Reported     0  
Region of Enrollment  
[units: participants]
 
United States     132  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Glycosylated Hemoglobin A1C (HbA1C) at the End of Each Treatment Period   [ Time Frame: Baseline, Week 12 and Week 24 ]

2.  Secondary:   Mean Daily Insulin Dose as Recorded During 10-Point Glucose Monitoring   [ Time Frame: Week 10 and Week 22 ]

3.  Secondary:   Percentage of Participants Meeting Glucose Targets at Least 2/3 of the Time   [ Time Frame: Baseline through Week 24, excluding 10-point glucose monitoring days ]

4.  Secondary:   Rates of Hypoglycemia at the End of Each Treatment Period   [ Time Frame: Week 12 and Week 24 ]

5.  Secondary:   Change From Baseline in Body Weight at the End of Each Treatment Period   [ Time Frame: Baseline, Week 12 and Week 24 ]

6.  Secondary:   Mean Daily PPG Excursions   [ Time Frame: Week 10 and Week 22 ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Titration Period Prior to randomization, all enrolled participants underwent a titration period of 4 to 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.
Insulin Lispro (Lispro-PH20 Cohort)

Participants randomized to the Lispro-PH20 cohort.

Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.

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

Lispro-PH20

Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.

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

Insulin Lispro (Aspart-PH20 Cohort)

Participants randomized to the Aspart-PH20 cohort.

Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.

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

Aspart-PH20

Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.

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


Other Adverse Events
    Titration Period     Insulin Lispro (Lispro-PH20 Cohort)     Lispro-PH20     Insulin Lispro (Aspart-PH20 Cohort)     Aspart-PH20  
Total, other (not including serious) adverse events            
# participants affected / at risk     34/132     19/59     29/59     32/60     35/62  
Blood and lymphatic system disorders            
Lymphadenopathy † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Lymphadenopathy mediastinal † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Anaemia † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Cardiac disorders            
Atrial fibrillation † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Coronary artery disease † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Palpitations † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Ear and labyrinth disorders            
Cerumen impaction † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Vertigo positional † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Endocrine disorders            
Hypogonadism † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Eye disorders            
Conjunctivitis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     1     1     0  
Retinopathy proliferative † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Vision blurred † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Chalazion † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Vitreous detachment † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Gastrointestinal disorders            
Diarrhoea † 1          
# participants affected / at risk     3/132 (2.27%)     0/59 (0.00%)     5/59 (8.47%)     2/60 (3.33%)     2/62 (3.23%)  
# events     3     0     5     2     2  
Nausea † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     3/59 (5.08%)     3/60 (5.00%)     2/62 (3.23%)  
# events     2     1     3     4     2  
Vomiting † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     2/59 (3.39%)     2/60 (3.33%)     1/62 (1.61%)  
# events     0     0     2     2     1  
Constipation † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Food poisoning † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Abdominal pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Abdominal pain upper † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Colonic polyp † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Diverticulum † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Dyspepsia † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Gastrooesophageal reflux disease † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Oral pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Toothache † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Tooth disorder † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Faeces hard † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
General disorders            
Oedema peripheral † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     2/59 (3.39%)     1/60 (1.67%)     1/62 (1.61%)  
# events     1     2     2     1     1  
Chest discomfort † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Facial pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Injection site haematoma † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     2/59 (3.39%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     2     0     0  
Injection site inflammation † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Non-cardiac chest pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Pyrexia † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Fatigue † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Immune system disorders            
Seasonal allergy † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Infections and infestations            
Nasopharyngitis † 1          
# participants affected / at risk     2/132 (1.52%)     2/59 (3.39%)     3/59 (5.08%)     7/60 (11.67%)     4/62 (6.45%)  
# events     2     2     4     7     4  
Influenza † 1          
# participants affected / at risk     2/132 (1.52%)     2/59 (3.39%)     1/59 (1.69%)     0/60 (0.00%)     1/62 (1.61%)  
# events     2     2     1     0     1  
Upper respiratory tract infection † 1          
# participants affected / at risk     6/132 (4.55%)     4/59 (6.78%)     7/59 (11.86%)     7/60 (11.67%)     3/62 (4.84%)  
# events     6     4     9     9     3  
Gastroenteritis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     3/60 (5.00%)     2/62 (3.23%)  
# events     0     0     0     3     2  
Gastroenteritis viral † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     1/59 (1.69%)     1/60 (1.67%)     0/62 (0.00%)  
# events     1     0     1     1     0  
Sinusitis † 1          
# participants affected / at risk     3/132 (2.27%)     1/59 (1.69%)     2/59 (3.39%)     2/60 (3.33%)     2/62 (3.23%)  
# events     3     1     2     2     2  
Bronchitis † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     1     1     0     1     1  
Cellulitis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     1     1     1  
Ear infection † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     1     0     1     0  
Acute sinusitis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Lobar pneumonia † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Herpes zoster † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Tonsillitis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Urinary tract infection † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Otitis externa † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Eye infection † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Parotitis † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Injury, poisoning and procedural complications            
Excoriation † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     2/59 (3.39%)     0/60 (0.00%)     2/62 (3.23%)  
# events     0     0     3     0     2  
Ligament sprain † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Muscle rupture † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Procedural pain † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Thermal burn † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Traumatic haematoma † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Contusion † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     2/62 (3.23%)  
# events     1     0     0     0     3  
Road traffic accident † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Muscle strain † 1          
# participants affected / at risk     2/132 (1.52%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     2     0     0     0     0  
Skin laceration † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Joint sprain † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Investigations            
Weight increased † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     2/62 (3.23%)  
# events     0     0     0     0     2  
Cardiac murmur † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Metabolism and nutrition disorders            
Increased appetite † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Central obesity † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Decreased appetite † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Hypoglycaemia † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Hypokalaemia † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Vitamin D deficiency † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Gout † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Musculoskeletal and connective tissue disorders            
Back pain † 1          
# participants affected / at risk     2/132 (1.52%)     1/59 (1.69%)     0/59 (0.00%)     2/60 (3.33%)     0/62 (0.00%)  
# events     2     1     0     2     0  
Intervertebral disc protrusion † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     1     0     1  
Osteoarthritis † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     1     0     1     0  
Pain in extremity † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     0/59 (0.00%)     3/60 (5.00%)     2/62 (3.23%)  
# events     1     1     0     3     3  
Flank pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Vertebral foraminal stenosis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Arthralgia † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     4/62 (6.45%)  
# events     1     0     0     0     6  
Musculoskeletal pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     2/62 (3.23%)  
# events     0     0     0     0     2  
Arthritis † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Metatarsalgia † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Muscle spasms † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Neck pain † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Temporomandibular joint syndrome † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Trigger finger † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     1     0     0     0     1  
Tendonitis † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)            
Lung neoplasm † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Uterine leiomyoma † 1          
# participants affected / at risk     0/53 (0.00%)     0/10 (0.00%)     0/10 (0.00%)     0/14 (0.00%)     1/15 (6.67%)  
# events     0     0     0     0     1  
Nervous system disorders            
Carpal tunnel syndrome † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     2/59 (3.39%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     1     2     0     0  
Headache † 1          
# participants affected / at risk     1/132 (0.76%)     2/59 (3.39%)     0/59 (0.00%)     2/60 (3.33%)     4/62 (6.45%)  
# events     1     2     0     2     5  
Cluster headache † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Diabetic neuropathy † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Neuropathy peripheral † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Post herpetic neuralgia † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Dizziness † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Migraine † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Psychiatric disorders            
Insomnia † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     1/59 (1.69%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     1     1     1     0  
Anxiety † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Delirium † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Depression † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Renal and urinary disorders            
Nephrolithiasis † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Dysuria † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Renal failure acute † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Reproductive system and breast disorders            
Erectile dysfunction † 1          
# participants affected / at risk     0/79 (0.00%)     1/38 (2.63%)     0/38 (0.00%)     0/34 (0.00%)     0/34 (0.00%)  
# events     0     1     0     0     0  
Prostatitis † 1          
# participants affected / at risk     1/79 (1.27%)     0/38 (0.00%)     0/38 (0.00%)     1/34 (2.94%)     0/34 (0.00%)  
# events     1     0     0     1     0  
Testicular pain † 1          
# participants affected / at risk     0/79 (0.00%)     0/38 (0.00%)     0/38 (0.00%)     0/34 (0.00%)     1/34 (2.94%)  
# events     0     0     0     0     1  
Testicular swelling † 1          
# participants affected / at risk     0/79 (0.00%)     0/38 (0.00%)     0/38 (0.00%)     0/34 (0.00%)     1/34 (2.94%)  
# events     0     0     0     0     1  
Respiratory, thoracic and mediastinal disorders            
Cough † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     1     1     0     1     1  
Rhinorrhoea † 1          
# participants affected / at risk     2/132 (1.52%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     1/62 (1.61%)  
# events     2     0     1     0     1  
Epistaxis † 1          
# participants affected / at risk     1/132 (0.76%)     1/59 (1.69%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     1     1     0     0  
Respiratory tract congestion † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Sinus congestion † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Rhinitis seasonal † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     1/62 (1.61%)  
# events     0     0     0     1     1  
Sleep apnoea syndrome † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     2/60 (3.33%)     0/62 (0.00%)  
# events     0     0     0     3     0  
Chronic obstructive pulmonary disease † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Dyspnoea † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Nasal congestion † 1          
# participants affected / at risk     1/132 (0.76%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     1     0     0     0     0  
Skin and subcutaneous tissue disorders            
Dermatitis contact † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     1     1     0  
Seborrhoeic dermatitis † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     1     0     1     0  
Rash † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     2/59 (3.39%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     2     0     0  
Blister † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Acanthosis nigricans † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     0     0     1  
Ingrowing nail † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     0/59 (0.00%)     1/60 (1.67%)     0/62 (0.00%)  
# events     0     0     0     1     0  
Hyperkeratosis † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Vascular disorders            
Hypertension † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     1/62 (1.61%)  
# events     0     0     1     0     1  
Flushing † 1          
# participants affected / at risk     0/132 (0.00%)     0/59 (0.00%)     1/59 (1.69%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     0     1     0     0  
Peripheral arterial occlusive disease † 1          
# participants affected / at risk     0/132 (0.00%)     1/59 (1.69%)     0/59 (0.00%)     0/60 (0.00%)     0/62 (0.00%)  
# events     0     1     0     0     0  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA (12.0)



  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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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
phone: 858-794-8889


No publications provided


Responsible Party: Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT01194258     History of Changes
Other Study ID Numbers: HALO-117-206
Study First Received: August 31, 2010
Results First Received: August 1, 2014
Last Updated: August 1, 2014
Health Authority: United States: Food and Drug Administration