Trial Outcomes & Findings for Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone (NCT NCT00862849)
NCT ID: NCT00862849
Last Updated: 2014-07-22
Results Overview
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100\*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
predose up to 30 minutes postdose
Results posted on
2014-07-22
Participant Flow
Participant milestones
| Measure |
Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone
Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone
Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
|---|---|---|---|---|---|---|
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Intervention 1
STARTED
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3
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5
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3
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4
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4
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3
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Intervention 1
Received at Least One Dose of Study Drug
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3
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5
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3
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4
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4
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3
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Intervention 1
COMPLETED
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3
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5
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3
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4
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4
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3
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Intervention 1
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Washout 1 (3 to 14 Days)
STARTED
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3
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5
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3
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4
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4
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3
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Washout 1 (3 to 14 Days)
COMPLETED
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3
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4
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3
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4
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4
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3
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Washout 1 (3 to 14 Days)
NOT COMPLETED
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0
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1
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0
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0
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0
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0
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Intervention 2
STARTED
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3
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4
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3
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4
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4
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3
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Intervention 2
COMPLETED
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3
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4
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3
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4
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4
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3
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Intervention 2
NOT COMPLETED
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0
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0
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0
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0
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0
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Washout 2 (3 to 14 Days)
STARTED
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3
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4
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3
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4
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4
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3
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Washout 2 (3 to 14 Days)
COMPLETED
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3
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3
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3
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4
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4
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3
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Washout 2 (3 to 14 Days)
NOT COMPLETED
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0
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1
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0
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0
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0
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0
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Intervention 3
STARTED
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3
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3
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3
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4
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4
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3
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Intervention 3
COMPLETED
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3
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3
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3
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4
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4
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3
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Intervention 3
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Washout 3 (3 to 14 Days)
STARTED
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3
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3
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3
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4
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4
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3
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Washout 3 (3 to 14 Days)
COMPLETED
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3
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3
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3
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4
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4
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3
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Washout 3 (3 to 14 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Intervention 4
STARTED
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3
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3
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3
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4
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4
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3
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Intervention 4
COMPLETED
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3
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3
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3
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4
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3
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Intervention 4
NOT COMPLETED
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0
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0
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0
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0
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0
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Washout 4 (3 to 14 Days)
STARTED
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3
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3
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3
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4
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4
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3
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Washout 4 (3 to 14 Days)
COMPLETED
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3
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3
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3
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4
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4
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3
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Washout 4 (3 to 14 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Intervention 5
STARTED
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3
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3
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3
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4
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4
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3
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Intervention 5
COMPLETED
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3
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3
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4
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3
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Intervention 5
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Washout 5 (3 to 14 Days)
STARTED
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3
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3
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3
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4
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4
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3
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Washout 5 (3 to 14 Days)
COMPLETED
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3
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3
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3
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4
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4
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3
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Washout 5 (3 to 14 Days)
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Intervention 6
STARTED
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3
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3
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3
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4
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4
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3
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Intervention 6
COMPLETED
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3
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3
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3
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4
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3
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Intervention 6
NOT COMPLETED
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0
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0
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0
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0
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0
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0
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Reasons for withdrawal
| Measure |
Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone
Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone
Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20
Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone
Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20
There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections.
|
|---|---|---|---|---|---|---|
|
Washout 1 (3 to 14 Days)
Withdrawal by Subject
|
0
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1
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0
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0
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0
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0
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Washout 2 (3 to 14 Days)
Protocol Violation
|
0
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1
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0
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0
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0
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0
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Baseline Characteristics
Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone
Baseline characteristics by cohort
| Measure |
All Participants
n=22 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).
Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)
Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20
Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone
There was a washout period of 3 to 14 days between interventions.
The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections.
|
|---|---|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (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 30 minutes postdosePopulation: Participants who completed all study visits and had evaluable %AUC(0-t) data.
Blood samples were taken 30, 20, 10 minutes (mins) prior to each injection; every 3 mins (from 0 to 15 mins); and every 5 mins (from 15 to 30 mins) after each injection. The percent coefficient of variation (CV%) was calculated as 100\*(standard deviation/mean). The intra-participant CV% was calculated directly from the 2 replications of each treatment. The CV% for percentage of total AUC is reported from 0 to 30 minutes.
Outcome measures
| Measure |
Insulin Lispro + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Intra-participant Variability in Percent of Total Area Under the Plasma Insulin Concentration-Versus-Time Curve Attained by Time T (%AUC[0-T])
|
14.04 percentage of coefficient of variance
Standard Deviation 11.12
|
23.81 percentage of coefficient of variance
Standard Deviation 12.43
|
40.51 percentage of coefficient of variance
Standard Deviation 24.30
|
SECONDARY outcome
Timeframe: predose up to 480 minutes postdosePopulation: Participants who completed all study visits and had 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 |
Insulin Lispro + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
early t(50%max)
|
14.14 minutes
Standard Deviation 3.01
|
21.52 minutes
Standard Deviation 4.95
|
24.73 minutes
Standard Deviation 5.16
|
|
Time to Early and Late 50% Maximum Serum Insulin Concentration (t[50%Max])
late t(50%max)
|
88.14 minutes
Standard Deviation 16.96
|
136.67 minutes
Standard Deviation 27.16
|
144.43 minutes
Standard Deviation 31.79
|
SECONDARY outcome
Timeframe: predose up to 480 minutes postdosePopulation: Participants who completed all study visits and had evaluable Cmax data.
Cmax was determined as the maximum of all valid serum insulin concentration measurements for each measurement series. 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 |
Insulin Lispro + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Peak Serum Insulin Concentration (Cmax)
|
782.85 picomoles per liter (pmol/L)
Standard Deviation 199.84
|
561.93 picomoles per liter (pmol/L)
Standard Deviation 141.88
|
482.40 picomoles per liter (pmol/L)
Standard Deviation 119.50
|
SECONDARY outcome
Timeframe: predose up to 480 minutes postdosePopulation: Participants who completed all study visits and had evaluable glucose infusion 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. Time to 25%, 50%, and 75% of total glucose infused are summarized.
Outcome measures
| Measure |
Insulin Lispro + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Time to Percentage of Total Glucose Infused
25%
|
72.38 minutes
Standard Deviation 12.50
|
91.58 minutes
Standard Deviation 15.85
|
99.13 minutes
Standard Deviation 19.26
|
|
Time to Percentage of Total Glucose Infused
50%
|
118.95 minutes
Standard Deviation 22.93
|
142.55 minutes
Standard Deviation 21.31
|
156.83 minutes
Standard Deviation 30.36
|
|
Time to Percentage of Total Glucose Infused
75%
|
179.23 minutes
Standard Deviation 40.73
|
203.15 minutes
Standard Deviation 31.12
|
222.48 minutes
Standard Deviation 44.44
|
SECONDARY outcome
Timeframe: predose up to 240 minutes postdosePopulation: Participants who completed all study visits and had evaluable glucose infusion 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); and every 30 mins (from 90 to 240 mins) after each injection. Percentage of total glucose infused from 0 to 4 hours is summarized.
Outcome measures
| Measure |
Insulin Lispro + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Percentage of Total Glucose Infused
|
88.70 percentage of total glucose infused
Standard Deviation 9.04
|
85.17 percentage of total glucose infused
Standard Deviation 7.89
|
79.81 percentage of total glucose infused
Standard Deviation 11.27
|
SECONDARY outcome
Timeframe: first dose through 7 to 10 days after last dosePopulation: Participants who received at least one dose of study drug (insulin lispro, regular human insulin, or recombinant human hyaluronidase \[rHuPH20\]).
The number of TEAEs related to study drug (as determined by the Investigator) are summarized. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Insulin Lispro + rHuPH20
n=22 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=21 Participants
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Number of Treatment Emergent Adverse Events (TEAEs) Related to Study Drug
|
1 events
|
0 events
|
3 events
|
Adverse Events
Insulin Lispro + rHuPH20
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Regular Human Insulin + rHuPH20
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Insulin Lispro Alone
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Insulin Lispro + rHuPH20
n=22 participants at risk
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Regular Human Insulin + rHuPH20
n=20 participants at risk
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
|
Insulin Lispro Alone
n=21 participants at risk
Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
0.00%
0/21
|
|
Gastrointestinal disorders
Nausea
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Catheter site pain
|
9.1%
2/22 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
9.5%
2/21 • Number of events 2
|
|
General disorders
Fatigue
|
0.00%
0/22
|
0.00%
0/20
|
0.00%
0/21
|
|
General disorders
Feeling hot
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/22
|
0.00%
0/20
|
9.5%
2/21 • Number of events 3
|
|
General disorders
Injection site irritation
|
0.00%
0/22
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
General disorders
Injection site pain
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
|
Infections and infestations
Upper respiratory tract infection
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/22
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/22
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
|
Nervous system disorders
Headache
|
0.00%
0/22
|
5.0%
1/20 • Number of events 1
|
4.8%
1/21 • Number of events 1
|
|
Nervous system disorders
Migraine
|
0.00%
0/22
|
0.00%
0/20
|
4.8%
1/21 • Number of events 1
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Number of events 1
|
0.00%
0/20
|
0.00%
0/21
|
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 written permission from the sponsor (Halozyme) is obtained.
- Publication restrictions are in place
Restriction type: OTHER