| Primary | Time to Maximum Serum Insulin Concentration (Tmax) | Time to maximum serum insulin concentration (tmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tmax data. | Posted | | Mean | Standard Deviation | Minutes | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone | Humulin-R: A single subcutaneous (SC) injection of 20 units (U) | | OG003 | Stage 2: Humulin-R + rHuPH20 | Humulin-R + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humulin-R and 240 U rHuPH20 |
| | Units | Counts |
|---|
| Participants | - OG00012
- OG00112
- OG00213
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00097.5± 35.9
- OG00148.0± 7.99
- OG002163± 51.5
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANOVA | | 0.0006 | Treatment comparison of Humalog alone and Humalog + rHuPH20 using a pairwise t-test. | | | | | | | | | | | | | Superiority or Other | | | | | ANOVA | |
|
| Primary | Maximum Serum Insulin Concentration (Cmax) | Maximum serum insulin concentration (Cmax) values for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable Cmax data. | Posted | | Mean | Standard Deviation | Picomoles per liter | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone | |
|
| Secondary | Time to Maximum Glucose Infusion Rate (tGIR[Max]) | Time to maximal effect for glucose infusion rate (tGIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained every 3 minutes during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(max) data. | Posted | | Mean | Standard Deviation | Minutes | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone | |
|
| Secondary | Time to Early Half-Maximal Effect for Glucose Infusion Rate (tGIR[early50%]) | Time to early half-maximal effect for glucose infusion rate (tGIR[early50%]) for participants who were randomized to Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable tGIR(early50%) data. | Posted | | Mean | Standard Deviation | Minutes | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1. Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20) : A single subcutaneous (SC) injection of 20 units (U) Humalog + 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone |
|
| Secondary | Time to Late Half-Maximal Effect for Glucose Infusion Rate (tGIR[late50%]) | Time to late half-maximal effect for glucose infusion rate (tGIR[late50%]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. Because the study was only 360 minutes in duration, there was not sufficient time for regular human insulin to show an effect and therefore tGIR(late50%) could not be calculated for participants receiving Humulin-R alone. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, or Humulin-R + rHuPH20 with evaluable tGIR(late50%) data. | Posted | | Mean | Standard Deviation | Minutes | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 |
|
| Primary | Area Under the Serum Concentration-Time Curve From Time Zero to the Time Required to Reach Endogenous Plasma Glucose Levels (AUC[0-t']) | Area under the serum concentration-time curve from time zero to the time required to reach endogenous plasma glucose levels (AUC[0-t']) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from 3 milliliter (mL) blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-t') data. | Posted | | Mean | Standard Deviation | Picomoles per liter times minutes | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | |
|
| Primary | Area Under the Concentration-Time Curve From Time 0 to Time to Reach Maximum Concentration (Tmax) for Serum Insulin With Recombinant Human Hyaluronidase PH20 (rHuPH20) (AUC[0-tmaxPH20]) | Area under the concentration-time curve from time 0 to time to reach maximum concentration (tmax) for serum insulin (Humalog or Humulin-R) with recombinant human hyaluronidase (rHuPH20) (AUC[0-tmaxPH20]) for participants who received Humalog or Humulin-R and with rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment and every 3 min from min 0 through 48 for Stage 1 and, and every 3 min from min 0 through 68 for Stage 2 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(0-tmaxPH20) data. | Posted | | Mean | Standard Deviation | Picomoles per liter times minutes | | Predose and up to 48 minutes postdose during Stage 1, or up to 68 minutes postdose during Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 |
|
| Primary | Relative Bioavailability (Area Under the Curve [AUC] for Insulin + Recombinant Human Hyaluronidase [rHuPH20] / AUC for Insulin Alone) | Relative bioavailability was determined by dividing the baseline-corrected geometric mean of the area under the curve (AUC) for insulin (ins) (Humalog or Humulin-R) with recombinant human hyaluronidase PH20 (rHuPH20) by the baseline-corrected geometric mean of the AUC for insulin alone (AUC[insulin+rHuPH20]/AUC[insulin]). Bioavailability values for participants who received Humalog or Humulin-R and rHuPH20 were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog + rHuPH20 or Humulin-R + rHuPH20 with evaluable relative bioavailability (AUC[insulin+rHuPH20]/AUC[insulin alone]) data. | Posted | | Mean | Standard Deviation | Ratio of AUC(ins+rHuPH20)/AUC(ins alone) | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) of Humalog and 300 U of rHuPH20 | | OG001 | Stage 2: Humulin-R + rHuPH20 | |
|
| Secondary | Maximum Glucose Infusion Rate (GIR[Max]) | Maximum glucose infusion rate (GIR[max]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase PH20 (rHuPH20) were measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 through 360 throughout the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable GIR(max) data. | Posted | | Mean | Standard Deviation | Milligrams per kilogram per minute | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone | |
|
| Secondary | Area Under the Glucose Infusion Rate Curve From 0 to 60 Minutes After Injection (AUC[GIR{0-60}]) | The area under the curve for the glucose infusion rate from minutes (min) 0 to 60 after injection (AUC[GIR{0-60}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment and every 3 min from min 0 through 60 during the clamp procedure. Means were calculated using analysis of variance with fixed of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-60]) data. | Posted | | Mean | Standard Deviation | Grams per kilogram | | Predose and up to 60 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone | |
|
| Secondary | Area Under the Glucose Infusion Rate Curve From 0 to 120 Minutes After Injection (AUC[GIR{0-120}]) | The area under the glucose infusion rate curve from minutes 0 to 120 after injection (AUC[GIR{0-120}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 minute (min) prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 120 during the clamp. Means were calculated using analysis of variance with fixed effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[0-120]) data. | Posted | | Mean | Standard Deviation | Grams per kilogram | | Predose and up to 120 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin Alone |
|
| Secondary | Area Under the Glucose Infusion Rate Curve From 0 to 180 Minutes After Injection (AUC[GIR{0-180}]) | The area under the curve for the glucose infusion rate from minutes (min) 0 to 180 after injection (AUC[GIR{0-180}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, and every 15 min from min 60 through 180 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[180]) data. | Posted | | Mean | Standard Deviation | Grams per kilogram | | Predose and up to 180 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone |
|
| Secondary | Area Under the Glucose Infusion Rate Curve From 0 to 240 Minutes After Injection (AUC[GIR{0-240}]) | The area the glucose infusion rate curve from minutes (min) 0 to 240 after injection (AUC[GIR{0-240}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 240 during the clamp procedure. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[240]) data. | Posted | | Mean | Standard Deviation | Grams per kilogram | | Predose up to 240 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone |
|
| Secondary | Area Under the Glucose Infusion Rate Curve From 0 to 360 Minutes After Injection (AUC[GIR{0-360}]) | The area under glucose infusion rate curve from minutes (min) 0 to 360 after injection (AUC[GIR{0-360}]) for participants who received Humalog or Humulin-R with or without recombinant human hyaluronidase (rHuPH20) was measured from blood samples obtained during a euglycemic clamp procedure. Samples were taken 10 and 1 min prior to treatment, every 3 min from min 0 through 60, every 15 min from min 60 through 180, and every 60 min from min 180 to 360 during the clamp. Means were calculated using analysis of variance with effects of participant, sequence within participant, treatment, and period. | Participants who received at least 1 dose of Humalog alone, Humalog + rHuPH20, Humulin-R alone, or Humulin-R + rHuPH20 with evaluable AUC(GIR[360]) data. | Posted | | Mean | Standard Deviation | Grams per kilogram | | Predose and up to 360 minutes postdose during Stage 1 or Stage 2 | | | | ID | Title | Description |
|---|
| OG000 | Stage 1: Humalog Alone | Humalog: A single subcutaneous (SC) injection of 20 units (U) | | OG001 | Stage 1: Humalog + rHuPH20 | Humalog + recombinant human hyaluronidase PH20 (rHuPH20): A single subcutaneous (SC) injection of 20 units (U) Humalog and 300 U rHuPH20 | | OG002 | Stage 2: Humulin-R Alone |
|