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The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.
Criteria for randomization into the study included 1) fasting blood glucose and predinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dL) approximately 60% of the time for 7 days prior to randomization 2) 90 minute or 2-hour postprandial blood glucose <220 mg/dL approximately 70% of the time for 7 days prior to randomization and 3) successfully completed 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lispro-PH20 / Insulin Lispro | Experimental | 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. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. 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 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. |
|
| Aspart-PH20 / Insulin Lispro | Experimental | 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. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. 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 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin lispro | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period | 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. | Baseline, Week 12 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Daily Insulin Dose | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Muchmore, M.D. | Halozyme Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute, Inc. | Escondido | California | 92026 | United States | ||
| Scripps Whittier Diabetes Institute |
The study included an open-label titration period of at least 4 weeks and up to 6 weeks prior to randomization at Week 0.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Participants | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Titration Period (4 to 6 Weeks) |
|
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| recombinant human hyaluronidase PH20 |
| Drug |
|
|
| Insulin aspart | Drug |
|
| Insulin glulisine | Drug |
|
|
| Insulin glargine | Drug |
|
|
| Week 10 and Week 22 |
| Percentage of Participants Meeting Glucose Targets | 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). | Baseline through Week 24, excluding 10-point glucose monitoring days |
| Rates of Hypoglycemia at the End of Each Treatment Period | 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. | Week 12 and Week 24 |
| Change From Baseline in Body Weight at the End of Each Treatment Period | 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). | Baseline, Week 12 and Week 24 |
| Mean Daily Postprandial Glucose (PPG) Excursions | 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. | Week 10 and Week 22 |
| La Jolla |
| California |
| 92037 |
| United States |
| Mills-Peninsula Health Services | San Mateo | California | 94401 | United States |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | United States |
| Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | United States |
| Diabetes Research Institute | Miami | Florida | 33136 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Mid-America Diabetes Associates | Wichita | Kansas | 67211 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Medstar Research Institute | Hyattsville | Maryland | 20782 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | United States |
| Mercury Street Medical | Butte | Montana | 59701 | United States |
| Desert Endocrinology | Henderson | Nevada | 89052 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| Texas Diabetes and Endocrinology | Round Rock | Texas | 78681 | United States |
| Cetero Research-San Antonio | San Antonio | Texas | 78229 | United States |
| West Olympia Internal Medicine | Olympia | Washington | 98502 | United States |
| University of Washington School of Medicine | Seattle | Washington | 98105 | United States |
| FG001 | Lispro-PH20 First, Then Insulin Lispro | 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. |
| FG002 | Insulin Lispro First, Then Lispro-PH20 | 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. |
| FG003 | Aspart-PH20 First, Then Insulin Lispro | 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. |
| FG004 | Insulin Lispro First, Then Aspart-PH20 | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Treatment Period 1 (Weeks 0 to 12) |
|
|
| Treatment Period 2 (Weeks 12 to 24) |
|
All enrolled participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Non-randomized Participants | 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. |
| BG001 | Lispro-PH20 First, Then Insulin Lispro | 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. |
| BG002 | Insulin Lispro First, Then Lispro-PH20 | 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. |
| BG003 | Aspart-PH20 First, Then Insulin Lispro | 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. |
| BG004 | Insulin Lispro First, Then Aspart-PH20 | 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. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Mean Daily Insulin Dose | 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). | Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable insulin dose data. | Posted | Mean | Standard Deviation | units (U) | Week 10 and Week 22 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Meeting Glucose Targets | 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). | Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose data. | Posted | Number | percentage of participants | Baseline through Week 24, excluding 10-point glucose monitoring days |
| |||||||||||||||||||||||||||||||
| Secondary | Rates of Hypoglycemia at the End of Each Treatment Period | 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. | Participants who completed both Treatment Period 1 and Treatment Period 2. | Posted | Number | events per participant per month | Week 12 and Week 24 |
|
| ||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period | 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. | Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable hemoglobin A1C data. | Posted | Mean | Standard Deviation | percentage of hemoglobin A1C | Baseline, Week 12 and Week 24 |
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Body Weight at the End of Each Treatment Period | 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). | Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable body weight data. | Posted | Mean | Standard Deviation | pounds (lbs) | Baseline, Week 12 and Week 24 |
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Daily Postprandial Glucose (PPG) Excursions | 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. | Participants who completed both Treatment Period 1 and Treatment Period 2 and had evaluable postprandial glucose (PPG) excursion data. | Posted | Mean | Standard Deviation | milligrams per deciliter (mg/dL) | Week 10 and Week 22 |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Titration Period (All Enrolled Participants) | 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. | 2 | 135 | 48 | 135 | ||
| EG001 | Lispro-PH20 Treatment Period | 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. | 0 | 56 | 34 | 56 | ||
| EG002 | Insulin Lispro (Lispro-PH20 Cohort) Treatment Period | 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. | 1 | 57 | 29 | 57 | ||
| EG003 | Aspart-PH20 Treatment Period | 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. | 0 | 58 | 27 | 58 | ||
| EG004 | Insulin Lispro (Aspart-PH20 Cohort) Treatment Period | 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. | 1 | 59 | 30 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Allergy to animal | Immune system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Astigmatism | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Candidiasis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Facet joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Gastrointestinal viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Goitre | Endocrine disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Gynaecomastia | Reproductive system and breast disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Injection site urticaria | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oesophageal obstruction | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oesophageal spasm | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Paranasal sinus hypersecretion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Rhinitis seasonal | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
| |
| Stasis dermatitis | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stress | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Stress at work | Social circumstances | MedDRA 12.0 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Synovial rupture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Trochanteric syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 12.0 | Systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice President, Endocrinology Clinical Development | Halozyme Therapeutics, Inc. | 858-794-8889 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| D061267 | Insulin Aspart |
| C479079 | insulin glulisine |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |
Not provided
Not provided
| Withdrawal by Subject |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
|
|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|