Trial Outcomes & Findings for Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus (NCT NCT00774800)
NCT ID: NCT00774800
Last Updated: 2019-02-26
Results Overview
AUC was derived as the area under the serum insulin concentration profile from 0 to time "t." Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Predose up to 60 minutes postdose
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R
Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.
Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.
Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.
Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.
Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was \<160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.
All dose finding visits and interventions were separated by 3-10 days.
|
|---|---|
|
Intervention 1
STARTED
|
22
|
|
Intervention 1
Received at Least One Dose of Study Drug
|
22
|
|
Intervention 1
COMPLETED
|
22
|
|
Intervention 1
NOT COMPLETED
|
0
|
|
Washout (3 to 10 Days)
STARTED
|
22
|
|
Washout (3 to 10 Days)
COMPLETED
|
22
|
|
Washout (3 to 10 Days)
NOT COMPLETED
|
0
|
|
Intervention 2
STARTED
|
22
|
|
Intervention 2
Received at Least One Dose of Study Drug
|
22
|
|
Intervention 2
COMPLETED
|
22
|
|
Intervention 2
NOT COMPLETED
|
0
|
|
Intervention 3
STARTED
|
22
|
|
Intervention 3
Received at Least One Dose of Study Drug
|
22
|
|
Intervention 3
COMPLETED
|
22
|
|
Intervention 3
NOT COMPLETED
|
0
|
|
Intervention 4
STARTED
|
22
|
|
Intervention 4
Received at Least One Dose of Study Drug
|
21
|
|
Intervention 4
COMPLETED
|
21
|
|
Intervention 4
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
First Humalog+PH20, Then Humalog, Humulin-R+PH20, Humulin-R
Humalog + Recombinant human hyaluronidase PH20 (rHuPH20) (Intervention 1): 24 units (U) of rHuPH20 per unit of Humalog, injected subcutaneously (SC), for up to 3 visits until an appropriate dose was identified.
Humalog alone (Intervention 2): a single SC injection of the appropriate identified dose of Humalog, delivered before a liquid meal.
Humulin-R + rHuPH20 (Intervention 3): 24 U of rHuPH20 per unit of Humulin-R, injected SC, for up to 2 visits until an appropriate dose was identified.
Humulin-R alone (Intervention 4): a single SC injection of the appropriate identified dose of Humulin-R, delivered before a liquid meal.
Appropriate dose of either Humalog or Humulin-R was that at which blood glucose following a liquid meal was \<160 milligrams per deciliter (mg/dL) for more than 30 minutes during the first 4 hours after injection and never fell below 60 mg/dL.
All dose finding visits and interventions were separated by 3-10 days.
|
|---|---|
|
Intervention 4
Withdrawal by Subject
|
1
|
Baseline Characteristics
Phase II Pharmacokinetics Study of Humalog and Humulin-R With and Without rHuPH20 in Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Overall Study
n=22 Participants
Humalog+recombinant human hyaluronidase PH20 (rHuPH20): Up to 3 dose-finding (DF) visits (each visit separated by 3-10 days \[d\]) until an appropriate dose of Humalog was identified. For each DF visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously (SC) per unit of Humalog, corresponding to a mass concentration (conc) of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final conc of 91 U/mL of Humalog)
Humalog alone: After a 3-10 d washout (wo), a single SC injection of the appropriate identified dose of Humalog was delivered
Humulin-R+rHuPH20: After a 3-10 d wo, up to 2 DF visits (both visits separated by 3-10 d) until an appropriate dose of Humulin-R was identified. For each DF visit, a total of 24 U of rHuPH20 was injected SC per unit of Humulin-R, corresponding to a mass conc of 20.0 μg/mL rHuPH20 (at final conc of 100 U/mL of Humulin-R)
Humulin-R alone: After a 3-10 d wo, a single SC injection of the appropriate identified dose of Humulin-R was delivered
|
|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 60 minutes postdosePopulation: Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC0-60 data.
AUC was derived as the area under the serum insulin concentration profile from 0 to time "t." Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; and at 20, 30, 45, and 60 mins postdose.
Outcome measures
| Measure |
Humalog + rHuPH20
n=21 Participants
Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
|
Humalog Alone
n=21 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
|
Humulin-R + rHuPH20
n=17 Participants
After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
|
Humulin-R Alone
n=17 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
|
|---|---|---|---|---|
|
Area Under the Insulin Concentration-time Curve for the First Hour (AUC0-60)
|
12346.67 nanomole*minute per liter (nmol*min/L)
Standard Deviation 4996.79 • Interval 10.98 to 24.78
|
8297.62 nanomole*minute per liter (nmol*min/L)
Standard Deviation 3670.03
|
11607.65 nanomole*minute per liter (nmol*min/L)
Standard Deviation 6770.61
|
4331.76 nanomole*minute per liter (nmol*min/L)
Standard Deviation 3068.10
|
SECONDARY outcome
Timeframe: Predose up to 480 minutes postdosePopulation: Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable Cmax data
Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.
Outcome measures
| Measure |
Humalog + rHuPH20
n=21 Participants
Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
|
Humalog Alone
n=21 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
|
Humulin-R + rHuPH20
n=17 Participants
After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
|
Humulin-R Alone
n=17 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
|
|---|---|---|---|---|
|
Maximum Serum Insulin Concentration (Cmax)
|
307.67 Picomoles per liter (pmol/L)
Standard Deviation 125.73 • Interval 0.78 to 0.92
|
226.38 Picomoles per liter (pmol/L)
Standard Deviation 85.51
|
285.88 Picomoles per liter (pmol/L)
Standard Deviation 139.54
|
165.05 Picomoles per liter (pmol/L)
Standard Deviation 68.98
|
SECONDARY outcome
Timeframe: Predose up to 480 minutes postdosePopulation: Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable tmax data.
Tmax was determined as the timepoint where the maximum of all valid concentration measurements for each measurement series was observed. Samples were taken 30, 20, and 10 minutes (mins) prior to treatment; every 3 mins from mins 0 through 15; at 20, 30, and 45 mins; every 30 mins from mins 60 through 240; and every 60 minutes from mins 300 through 480 postdose.
Outcome measures
| Measure |
Humalog + rHuPH20
n=21 Participants
Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
|
Humalog Alone
n=21 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
|
Humulin-R + rHuPH20
n=17 Participants
After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
|
Humulin-R Alone
n=17 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
|
|---|---|---|---|---|
|
Time to Maximum Serum Insulin Concentration (Tmax)
|
30.24 minutes
Standard Deviation 8.73
|
48.57 minutes
Standard Deviation 13.34
|
57.06 minutes
Standard Deviation 30.83
|
116.76 minutes
Standard Deviation 65.02
|
SECONDARY outcome
Timeframe: Predose up to 4 hours after injection of study drugPopulation: Participants who received at least one dose of Humalog alone, Humalog + rHuPH20, Humulin-R + rHuPH20, or Humulin-R alone with evaluable AUC(BG) data.
AUC(BG) values are reported for participants whose blood glucose (BG) was elevated higher than 140 milligrams per deciliter (mg/dL) within 4 hours of consuming a liquid meal. Blood samples were collected at 30, 20, 10, and within 5 minutes before; at 3, 6, 9, 12, 15, 20, 25 minutes; and every 10 minutes from minute 30 to 240 postdose.
Outcome measures
| Measure |
Humalog + rHuPH20
n=22 Participants
Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
|
Humalog Alone
n=22 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
|
Humulin-R + rHuPH20
n=21 Participants
After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
|
Humulin-R Alone
n=21 Participants
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
|
|---|---|---|---|---|
|
Area Under the Blood Glucose Time-Concentration Curve Blood Glucose (AUC[BG])
|
111 minutes*milligrams per deciliter
Interval 35.0 to 357.0
|
526 minutes*milligrams per deciliter
Interval 164.0 to 1685.0
|
181 minutes*milligrams per deciliter
Interval 57.0 to 581.0
|
1,238 minutes*milligrams per deciliter
Interval 343.0 to 4466.0
|
Adverse Events
Humalog + rHuPH20
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Humalog Alone
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Humulin-R + rHuPH20
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Humulin-R Alone
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Humalog + rHuPH20
n=22 participants at risk
Humalog + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 3 dose-finding visits (each visit was separated by 3-10 days) until an appropriate dose of Humalog was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humalog, corresponding to a mass concentration of 18.2 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 91 U/mL of Humalog).
|
Humalog Alone
n=22 participants at risk
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humalog was delivered before a liquid meal.
|
Humulin-R + rHuPH20
n=22 participants at risk
After a 3-10 day washout, Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20) was delivered for up to 2 dose-finding visits (both visits were separated by 3-10 days) until an appropriate dose of Humulin-R was identified. For each dose-finding visit, a total of 24 units (U) of rHuPH20 was injected subcutaneously per unit of Humulin-R, corresponding to a mass concentration of 20.0 micrograms per milliliter (μg/mL) rHuPH20 (at final concentration of 100 U/mL of Humulin-R).
|
Humulin-R Alone
n=21 participants at risk
After a 3-10 day washout, a single subcutaneous injection of the appropriate identified dose of Humulin-R was delivered before a liquid meal.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
General disorders
Injection site erythema
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
9.1%
2/22 • Number of events 2 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Infections and infestations
Viral infection
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.8%
1/21 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.8%
1/21 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Investigations
Blood glucose decreased
|
59.1%
13/22 • Number of events 33 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
50.0%
11/22 • Number of events 17 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
63.6%
14/22 • Number of events 39 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
66.7%
14/21 • Number of events 25 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
22.7%
5/22 • Number of events 6 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
18.2%
4/22 • Number of events 6 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
40.9%
9/22 • Number of events 13 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
33.3%
7/21 • Number of events 9 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.8%
1/21 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Nervous system disorders
Headache
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
13.6%
3/22 • Number of events 3 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
13.6%
3/22 • Number of events 3 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.8%
1/21 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 2 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/22 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
4.5%
1/22 • Number of events 1 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
0.00%
0/21 • Adverse event data collected from Day 1 through to the end of the study, for up to 80 days.
|
Additional Information
Vice President, Endocrinology Clinical Development
Halozyme Therapeutics, Inc.
Phone: (858) 794-8889
Results disclosure agreements
- Principal investigator is a sponsor employee 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 prior written permission from the Sponsor (Halozyme) is obtained.
- Publication restrictions are in place
Restriction type: OTHER