| Outcome Measures: |
Primary: Percentage of Participants With Clinically Significant Hypoglycemia, The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose \<54 milligrams per deciliter (mg/dL) (3.0 millimole per liter \[mmol/L\]) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100., Predose to 84 Hours Post Double Dose | Secondary: Percentage of Participants With Clinically Significant Hypoglycemia 12 Hours Post Double Dose, The percentage was calculated by dividing the number of participants with clinically significant hypoglycemia events defined as blood glucose \<54 mg/dL (3.0 mmol/L) or symptoms of severe hypoglycemia by the total number of participants analyzed, multiplied by 100., Predose to 12 Hours Post Double Dose|Percentage of Participants With Hypoglycemia, The percentage was calculated by dividing the number of participants with hypoglycemia events defined as blood glucose ≤70 mg/dL (3.9 mmol/L) by the total number of participants analyzed, multiplied by 100., Predose to 12 Hours Post Double Dose and 84 Hours Post Double Dose|Nadir Glucose, Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor., Predose to 84 Hours Post Double Dose|Time to the Nadir Glucose, Nadir glucose was defined as the lowest blood glucose for a participant with blood glucose ≤70 mg/dL (3.9 mmol/L). The average time was calculated by dividing the sum of time from double dose to the nadir glucose for participants with blood glucose ≤70 mg/dL (3.9 mmol/L) by the number of participants with blood glucose ≤70 mg/dL (3.9 mmol/L) during the first 84 hours after the double dose., Predose to 84 Hours Post Double Dose|Duration of Glucose ≤70 mg/dL, The duration in minutes of each hypoglycemia episode with glucose ≤70 mg/dL (3.9 mmol/L) was calculated from start time to end time. The duration for a participant was the sum of the durations over the multiple hypoglycemia episodes. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor., Predose to 84 Hours Post Double Dose|Fasting Blood Glucose, Fasting blood glucose (FBG) was measured by self-monitored blood glucose. LS means were calculated by MMRM analysis with fixed effects of treatment, dosing day, sequence, period, interaction of treatment and dosing day, baseline basal insulin dose stratification factor, and baseline FBG., Day 1, Day 2, and Day 3 Following Double Dose|Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC), Glucose AUC within 3 hours after each meal assessed by the AUC of glucose from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor., Preprandial to 3 Hours Postprandial during the day following the standard dose|Pharmacodynamics: Three-Hour Postprandial Glucose Area Under the Concentration Time Curve (AUC) Excursion, Glucose AUC excursion within 3 hours after each meal assessed by the AUC of adjusted glucose (= observed glucose - preprandial glucose) from preprandial to 3 hours postprandial. LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor., Preprandial to 3 Hours Postprandial during the day following the standard dose|Beta Cell Function, Beta cell function assessed by the change between pre meal tolerance test and 30 minutes post meal tolerance test in C-peptide corrected insulin/Glucose (ΔC-peptide corrected insulin/ΔGlucose). LS means were calculated using an MMRM analysis including the following fixed effects: treatment, period, sequence, and baseline basal insulin dose stratification factor., 0-30 minutes during the meal tolerance test on the day following the standard dose
|
| Locations: |
Profil Institute for Clinical Research Inc, Chula Vista, California, 91911, United States|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Mainz, 55116, Germany|For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Neuss, 41460, Germany
|
