Trial Outcomes & Findings for A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone (NCT NCT00979875)
NCT ID: NCT00979875
Last Updated: 2014-07-14
Results Overview
Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
14 participants
Primary outcome timeframe
Predose up to 60 minutes postdose
Results posted on
2014-07-14
Participant Flow
Participant milestones
| Measure |
Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20
Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.
|
Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart
Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.
|
Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20
Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.
|
Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro
Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.
After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.
|
Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20
Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.
|
Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis
Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.
After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.
|
|---|---|---|---|---|---|---|
|
Intervention 1
STARTED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 1
Received at Least 1 Dose of Study Drug
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 1
COMPLETED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 1 (3 to 14 Days)
STARTED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Washout 1 (3 to 14 Days)
COMPLETED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Washout 1 (3 to 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 2
STARTED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 2
COMPLETED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Washout 2 (3 to 14 Days)
STARTED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Washout 2 (3 to 14 Days)
COMPLETED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Washout 2 (3 to 14 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Intervention 3
STARTED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 3
COMPLETED
|
2
|
2
|
3
|
2
|
3
|
2
|
|
Intervention 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
Baseline characteristics by cohort
| Measure |
Overall Study
n=14 Participants
All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.
Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.
Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.
Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart.
|
|---|---|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Predose up to 60 minutes postdosePopulation: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-60 data.
Area under the concentration (AUC)-time curve was derived as the area under the serum insulin concentration profile from 0 to 60 minutes. Blood samples were taken 30, 20, and 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and at 20, 25, 30, 45, and 60 mins after each injection.
Outcome measures
| Measure |
Glulisine Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve for Serum Insulin From Time 0 to 60 Minutes (AUC0-60)
|
11667.14 minutes*nanomolars (min*nM)
Standard Deviation 4085.00
|
23807.14 minutes*nanomolars (min*nM)
Standard Deviation 6657.73
|
10687.14 minutes*nanomolars (min*nM)
Standard Deviation 5532.49
|
27850.00 minutes*nanomolars (min*nM)
Standard Deviation 9684.94
|
8065.00 minutes*nanomolars (min*nM)
Standard Deviation 3138.37
|
20778.57 minutes*nanomolars (min*nM)
Standard Deviation 6383.05
|
SECONDARY outcome
Timeframe: Predose up to 480 minutes postdosePopulation: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 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, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Outcome measures
| Measure |
Glulisine Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
Time to Maximum Serum Insulin Concentration (Tmax)
|
80.36 minutes
Standard Deviation 25.38
|
41.43 minutes
Standard Deviation 12.47
|
67.50 minutes
Standard Deviation 32.09
|
41.07 minutes
Standard Deviation 17.56
|
85.71 minutes
Standard Deviation 35.99
|
43.57 minutes
Standard Deviation 12.92
|
SECONDARY outcome
Timeframe: Predose up to 480 minutes postdosePopulation: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable t(50%max) data.
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Outcome measures
| Measure |
Glulisine Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
early t(50%max)
|
21.06 minutes
Standard Deviation 9.60
|
10.16 minutes
Standard Deviation 4.90
|
30.69 minutes
Standard Deviation 12.58
|
18.96 minutes
Standard Deviation 5.27
|
31.93 minutes
Standard Deviation 8.15
|
17.98 minutes
Standard Deviation 5.22
|
|
Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
late t(50%max)
|
195.43 minutes
Standard Deviation 48.63
|
118.92 minutes
Standard Deviation 33.57
|
176.79 minutes
Standard Deviation 30.00
|
89.59 minutes
Standard Deviation 21.38
|
193.50 minutes
Standard Deviation 45.94
|
102.82 minutes
Standard Deviation 24.74
|
SECONDARY outcome
Timeframe: Predose up to 480 minutes postdosePopulation: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20), Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable tGIR(max) data.
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Outcome measures
| Measure |
Glulisine Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
Time to Maximum Glucose Infusion Rate (tGIR[Max])
|
141.93 minutes
Standard Deviation 71.18
|
113.36 minutes
Standard Deviation 69.85
|
160.14 minutes
Standard Deviation 71.36
|
103.57 minutes
Standard Deviation 58.83
|
158.79 minutes
Standard Deviation 52.34
|
96.93 minutes
Standard Deviation 56.65
|
SECONDARY outcome
Timeframe: Predose up to 120 minutes postdosePopulation: Participants who received at least one dose of Lispro alone, Lispro + recombinant human hyaluronidase PH20 (rHuPH20) , Glulisine alone, Glulisine + rHuPH20, Aspart alone, or Aspart + rHuPH20 with evaluable AUC0-t data.
Percentage of total area under the concentration (AUC)-time curve at 15, 30, 60, 120 minutes after injection was measured. Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); and at 90 and 120 mins after each injection.
Outcome measures
| Measure |
Glulisine Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
AUC0-15
|
2.02 percentage of total AUC
Standard Deviation 1.10
|
5.29 percentage of total AUC
Standard Deviation 2.06
|
0.68 percentage of total AUC
Standard Deviation 0.65
|
2.38 percentage of total AUC
Standard Deviation 1.24
|
0.56 percentage of total AUC
Standard Deviation 0.30
|
2.92 percentage of total AUC
Standard Deviation 2.28
|
|
Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
AUC0-30
|
7.09 percentage of total AUC
Standard Deviation 3.40
|
15.82 percentage of total AUC
Standard Deviation 5.56
|
3.88 percentage of total AUC
Standard Deviation 2.71
|
13.81 percentage of total AUC
Standard Deviation 5.37
|
3.54 percentage of total AUC
Standard Deviation 1.90
|
13.66 percentage of total AUC
Standard Deviation 7.05
|
|
Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
AUC0-60
|
20.68 percentage of total AUC
Standard Deviation 8.07
|
39.45 percentage of total AUC
Standard Deviation 10.64
|
18.72 percentage of total AUC
Standard Deviation 7.74
|
42.88 percentage of total AUC
Standard Deviation 8.89
|
16.85 percentage of total AUC
Standard Deviation 6.54
|
41.51 percentage of total AUC
Standard Deviation 12.06
|
|
Percentage of Total Area Under the Concentration-time Curve for Serum Insulin Attained by Time t (AUC0-t)
AUC0-120
|
50.35 percentage of total AUC
Standard Deviation 12.69
|
71.70 percentage of total AUC
Standard Deviation 11.07
|
50.14 percentage of total AUC
Standard Deviation 12.10
|
77.00 percentage of total AUC
Standard Deviation 7.54
|
47.97 percentage of total AUC
Standard Deviation 12.32
|
77.37 percentage of total AUC
Standard Deviation 8.80
|
SECONDARY outcome
Timeframe: Predose up to 480 minutes postdosePopulation: Participants who received at least one dose of Lispro alone, Lispro + rHuPH20, Glulisine alone, Glulisine + recombinant human hyaluronidase PH20 (rHuPH20), Aspart alone, or Aspart + rHuPH20 with evaluable total insulin exposure data.
Time to 10% and 50% of total insulin exposure was measured. Samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); every 5 mins (from 15 to 30 mins); every 15 mins (from 30 to 90 mins); every 30 mins (from 90 to 240 mins); and every 60 mins (from 240 to 480 mins) after each injection.
Outcome measures
| Measure |
Glulisine Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 Participants
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
Time to Percentage of Total Insulin Exposure
Time to 10% of total insulin exposure
|
39.59 minutes
Standard Deviation 9.95
|
23.39 minutes
Standard Deviation 6.38
|
46.56 minutes
Standard Deviation 11.89
|
26.35 minutes
Standard Deviation 5.60
|
48.42 minutes
Standard Deviation 9.96
|
26.99 minutes
Standard Deviation 6.57
|
|
Time to Percentage of Total Insulin Exposure
Time to 50% of total insulin exposure
|
123.65 minutes
Standard Deviation 27.48
|
78.64 minutes
Standard Deviation 18.82
|
123.39 minutes
Standard Deviation 27.87
|
70.97 minutes
Standard Deviation 12.61
|
130.86 minutes
Standard Deviation 30.04
|
72.53 minutes
Standard Deviation 14.86
|
Adverse Events
Glulisine Alone
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Glulisine + rHuPH20
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lispro Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Lispro + rHuPH20
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Aspart Alone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Aspart + rHuPH20
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Glulisine Alone
n=14 participants at risk
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
|
Glulisine + rHuPH20
n=14 participants at risk
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Lispro Alone
n=14 participants at risk
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
|
Lispro + rHuPH20
n=14 participants at risk
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
Aspart Alone
n=14 participants at risk
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
|
Aspart + rHuPH20
n=14 participants at risk
Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
|
|---|---|---|---|---|---|---|
|
General disorders
Infusion site anaesthesia
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
|
General disorders
Infusion site pain
|
0.00%
0/14
|
7.1%
1/14 • Number of events 2
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
|
Infections and infestations
Infusion site abscess
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
|
Nervous system disorders
Headache
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/14
|
0.00%
0/14
|
7.1%
1/14 • Number of events 1
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/14
|
Additional Information
Vice President, Endocrinology Clinical Development
Halozyme Therapeutics, Inc.
Phone: (858) 794-8889
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60