Type 1 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to see if LY900014 compared to insulin lispro (Humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (T1D).
Interventions
DRUGLY900014
Administered SC
DRUGInsulin Lispro
Administered SC
DRUGInsulin Glargine
Administered SC
DRUGInsulin Degludec
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have T1D for at least 1 year prior to screening and continuously using insulin for at least 1 year. * Participants must have HbA1c of ≥7.0 and ≤10.0%. * Participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (MDI) or premixed analog/human insulin regimens at least twice daily. * Participants must have body mass index (BMI) of ≤35.0 kilograms per square meter (kg/m2).
Exclusion criteria
* Participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening. * Participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening. * Participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 26 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) | Week 26 | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. |
| 2-hour PPG Excursion During MMTT | Week 26 | A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables. |
| Rate of Severe Hypoglycemia | Baseline through Week 26 | Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group \*36525 days. |
| Rate of Documented Symptomatic Post Meal Hypoglycemia | Baseline through Week 26 | Documented symptomatic post meal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL \[3.9 millimole per liter (mmol/L)\]. The rate of documented symptomatic post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group \*365.25. |
| Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Baseline, Week 26 | SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Change From Baseline in Daily Insulin Dose | Baseline, Week 26 | LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
| Percentage of Participants With HbA1c <7% and ≤6.5% | Week 26 | HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. |
| Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) | Baseline, Week 26 | 1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables. |
Countries
Argentina, China, Mexico
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Insulin Lispro (Humalog) Participants received 100 U/mL insulin lispro SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 178 |
| LY900014 Participants received 100 U/mL LY900014 SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 176 |
| Total | 354 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 5 |
Baseline characteristics
| Characteristic | LY900014 | Total | Insulin Lispro (Humalog) |
|---|---|---|---|
| Age, Continuous | 40.30 years STANDARD_DEVIATION 13.42 | 42.00 years STANDARD_DEVIATION 13.72 | 43.60 years STANDARD_DEVIATION 13.84 |
| Hemoglobin A1c (HbA1c) | 7.87 Percentage of HbA1c STANDARD_DEVIATION 0.95 | 7.85 Percentage of HbA1c STANDARD_DEVIATION 0.93 | 7.82 Percentage of HbA1c STANDARD_DEVIATION 0.91 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 144 Participants | 285 Participants | 141 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 27 Participants | 58 Participants | 31 Participants |
| Region of Enrollment Argentina | 18 Participants | 39 Participants | 21 Participants |
| Region of Enrollment China | 144 Participants | 285 Participants | 141 Participants |
| Region of Enrollment Mexico | 14 Participants | 30 Participants | 16 Participants |
| Sex: Female, Male Female | 82 Participants | 160 Participants | 78 Participants |
| Sex: Female, Male Male | 94 Participants | 194 Participants | 100 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 178 | 0 / 176 |
| other Total, other adverse events | 29 / 178 | 28 / 176 |
| serious Total, serious adverse events | 12 / 178 | 13 / 176 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All randomized participants with baseline and at least one post-baseline HbA1c data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro (Humalog) | Change From Baseline in Hemoglobin A1c (HbA1c) | -0.28 Percentage of HbA1c | Standard Error 0.063 |
| LY900014 | Change From Baseline in Hemoglobin A1c (HbA1c) | -0.21 Percentage of HbA1c | Standard Error 0.064 |
95% CI: [-0.11, 0.24]
Secondary
1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT)
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 1-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Time frame: Week 26
Population: All randomized participants with baseline and at least one post-baseline 1-hour PPG excursion data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro (Humalog) | 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) | 102.8 milligrams per deciliter (mg/dL) | Standard Error 4.23 |
| LY900014 | 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) | 85.0 milligrams per deciliter (mg/dL) | Standard Error 4.14 |
p-value: 0.00395% CI: [-29.4, -6.1]ANCOVA
Secondary
2-hour PPG Excursion During MMTT
A standardized MMTT was used to characterize postprandial glucose control following administration of the study insulin. Serum glucose measured at 2-hour timepoint after the start of meal minus fasting serum glucose. LS mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares) as variables.
Time frame: Week 26
Population: All randomized participants with baseline and at least one post-baseline 2-hour PPG excursion data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro (Humalog) | 2-hour PPG Excursion During MMTT | 142.2 mg/dL | Standard Error 5.63 |
| LY900014 | 2-hour PPG Excursion During MMTT | 116.7 mg/dL | Standard Error 5.49 |
p-value: 0.00195% CI: [-41.1, -10]ANCOVA
Secondary
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
SMBG 10-point profiles were measured at morning (premeal-fasting, 1-hour post meal, 2-hour post meal), midday (premeal, 1-hour post meal, 2-hour post meal), evening (premeal, 1-hour post meal, 2-hour post meal) and bedtime. LS Mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All randomized participants with baseline and at least one post-baseline SMBG data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning premeal-fasting | 5.5 milligrams per deciliter (mg/dL) | Standard Error 2.9 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 1-hour post meal | -6.4 milligrams per deciliter (mg/dL) | Standard Error 3.53 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 2-hour postmeal | -9.5 milligrams per deciliter (mg/dL) | Standard Error 3.63 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday premeal | -6.7 milligrams per deciliter (mg/dL) | Standard Error 3.25 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 1-hour post meal | -4.7 milligrams per deciliter (mg/dL) | Standard Error 3.34 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 2-hour post meal | -10.8 milligrams per deciliter (mg/dL) | Standard Error 3.31 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening premeal | -12.2 milligrams per deciliter (mg/dL) | Standard Error 4 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 1-hour post meal | -2.4 milligrams per deciliter (mg/dL) | Standard Error 3.54 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 2-hour post meal | -7.0 milligrams per deciliter (mg/dL) | Standard Error 3.5 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Bedtime | -7.9 milligrams per deciliter (mg/dL) | Standard Error 3.84 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 1-hour post meal | -8.0 milligrams per deciliter (mg/dL) | Standard Error 3.52 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning premeal-fasting | -10.2 milligrams per deciliter (mg/dL) | Standard Error 2.9 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 2-hour post meal | -14.1 milligrams per deciliter (mg/dL) | Standard Error 3.33 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 1-hour post meal | -20.4 milligrams per deciliter (mg/dL) | Standard Error 3.51 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Bedtime | -12.4 milligrams per deciliter (mg/dL) | Standard Error 3.82 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 2-hour postmeal | -24.4 milligrams per deciliter (mg/dL) | Standard Error 3.62 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening premeal | -1.6 milligrams per deciliter (mg/dL) | Standard Error 4.01 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday premeal | -9.0 milligrams per deciliter (mg/dL) | Standard Error 3.26 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 2-hour post meal | -14.8 milligrams per deciliter (mg/dL) | Standard Error 3.5 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 1-hour post meal | -13.8 milligrams per deciliter (mg/dL) | Standard Error 3.33 |
Comparison: Morning premeal-fastingp-value: <0.00195% CI: [-23.8, -7.7]Mixed Models Analysis
Comparison: Morning 1-hour post mealp-value: 0.00595% CI: [-23.8, -4.2]Mixed Models Analysis
Comparison: Morning 2-hour post mealp-value: 0.00495% CI: [-25, -4.8]Mixed Models Analysis
Comparison: Midday premealp-value: 0.61695% CI: [-11.4, 6.8]Mixed Models Analysis
Comparison: Midday 1-hour post mealp-value: 0.05495% CI: [-18.4, 0.1]Mixed Models Analysis
Comparison: Midday 2-hour post mealp-value: 0.48395% CI: [-12.6, 6]Mixed Models Analysis
Comparison: Evening premealp-value: 0.06495% CI: [-0.6, 21.7]Mixed Models Analysis
Comparison: Evening 1-hour post mealp-value: 0.26295% CI: [-15.5, 4.2]Mixed Models Analysis
Comparison: Evening 2-hour post mealp-value: 0.11795% CI: [-17.5, 2]Mixed Models Analysis
Comparison: Bedtimep-value: 0.41495% CI: [-15.1, 6.2]Mixed Models Analysis
Secondary
Change From Baseline in 1,5-Anhydroglucitol (1,5-AG)
1,5-anhydroglucitol (1,5-AG) is a marker of short-term glycemic control especially postprandial hyperglycemia. It accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All randomized participants with baseline and at least one post-baseline 1,5-AG data.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Insulin Lispro (Humalog) | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) | 0.39 milligrams per liter (mg/L) | Standard Error 0.202 |
| LY900014 | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) | 0.10 milligrams per liter (mg/L) | Standard Error 0.203 |
p-value: 0.30995% CI: [-0.86, 0.27]Mixed Models Analysis
Secondary
Change From Baseline in Daily Insulin Dose
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Use of Metformin at Study Entry + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) as variables.
Time frame: Baseline, Week 26
Population: All randomized participants with baseline and at least one post-baseline insulin dose data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro (Humalog) | Change From Baseline in Daily Insulin Dose | Basal Insulin Dose | 0.0 Units per day | Standard Error 0.24 |
| Insulin Lispro (Humalog) | Change From Baseline in Daily Insulin Dose | Bolus Insulin Dose | 6.0 Units per day | Standard Error 0.69 |
| Insulin Lispro (Humalog) | Change From Baseline in Daily Insulin Dose | Total Insulin Dose | 6.0 Units per day | Standard Error 0.75 |
| LY900014 | Change From Baseline in Daily Insulin Dose | Basal Insulin Dose | 0.0 Units per day | Standard Error 0.24 |
| LY900014 | Change From Baseline in Daily Insulin Dose | Bolus Insulin Dose | 6.6 Units per day | Standard Error 0.7 |
| LY900014 | Change From Baseline in Daily Insulin Dose | Total Insulin Dose | 6.6 Units per day | Standard Error 0.76 |
Comparison: Basal insulin dosep-value: 0.94795% CI: [-0.7, 0.6]Mixed Models Analysis
Comparison: Bolus insulin dosep-value: 0.595% CI: [-1.3, 2.6]Mixed Models Analysis
Comparison: Total insulin dosep-value: 0.54395% CI: [-1.4, 2.7]Mixed Models Analysis
Secondary
Percentage of Participants With HbA1c <7% and ≤6.5%
HbA1c is the glycosylated fraction of hemoglobin A. It is measured to identify average plasma glucose concentration over prolonged periods of time.
Time frame: Week 26
Population: All randomized participants with baseline and at least one post-baseline HbA1c data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro (Humalog) | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c < 7% | 28.48 Percentage of participants |
| Insulin Lispro (Humalog) | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c ≤ 6.5% | 15.15 Percentage of participants |
| LY900014 | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c < 7% | 26.71 Percentage of participants |
| LY900014 | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c ≤ 6.5% | 9.94 Percentage of participants |
Comparison: For HbA1c \< 7%p-value: 0.46295% CI: [0.47, 1.42]Regression, Logistic
Comparison: For HbA1c ≤6.5%p-value: 0.08995% CI: [0.26, 1.1]Regression, Logistic
Secondary
Rate of Documented Symptomatic Post Meal Hypoglycemia
Documented symptomatic post meal hypoglycemia is an event during which typical symptoms of hypoglycemia are accompanied by blood glucose (BG) of ≤70 mg/dL \[3.9 millimole per liter (mmol/L)\]. The rate of documented symptomatic post meal hypoglycemia per year during a defined period is calculated by the total number of documented symptomatic post meal hypoglycemia events within the period divided by the cumulative days on treatment from all participants within that treatment group \*365.25.
Time frame: Baseline through Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline, at least one post-baseline hypoglycemic data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=2 hours post meal | 3.80 Events per participant per year |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | >1 to <=2 hours post meal | 3.05 Events per participant per year |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=1 hour post meal | 0.75 Events per participant per year |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | >2 to <=4 hours post meal | 6.40 Events per participant per year |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=4 hours post meal | 10.2 Events per participant per year |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | >4 hours post meal | 14.2 Events per participant per year |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=30 minutes post meal | 0.11 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | >4 hours post meal | 10.5 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=30 minutes post meal | 0.09 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=1 hour post meal | 1.20 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=2 hours post meal | 4.52 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | <=4 hours post meal | 12.4 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | >1 to <=2 hours post meal | 3.32 Events per participant per year |
| LY900014 | Rate of Documented Symptomatic Post Meal Hypoglycemia | >2 to <=4 hours post meal | 7.87 Events per participant per year |
Comparison: \<=30 minutes post mealp-value: 0.98395% CI: [0.72, 1.38]Negative binomial regression
Comparison: \<=1 hour post mealp-value: 0.07695% CI: [0.95, 2.74]Negative binomial regression
Comparison: \<=2 hours post mealp-value: 0.40995% CI: [0.79, 1.79]Negative binomial regression
Comparison: \<=4 hours post mealp-value: 0.21795% CI: [0.89, 1.68]Negative binomial regression
Comparison: \>1 to \<=2 hours post mealp-value: 0.70395% CI: [0.71, 1.65]Negative binomial regression
Comparison: \>2 to \<=4 hours post mealp-value: 0.20695% CI: [0.89, 1.73]Negative binomial regression
Comparison: \>4 hours post mealp-value: 0.08295% CI: [0.55, 1.04]Negative binomial regression
Secondary
Rate of Severe Hypoglycemia
Severe hypoglycemia is defined as an event requiring assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Rate of severe hypoglycemia events per 100 years during a defined period was calculated by total number of severe hypoglycemia episodes within the period divided by the cumulative days on treatment from all participants within that treatment group \*36525 days.
Time frame: Baseline through Week 26
Population: All randomized participants who received at least one dose of study drug and had baseline, at least one post-baseline hypoglycemic data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Lispro (Humalog) | Rate of Severe Hypoglycemia | 6.88 Events per 100 participant years |
| LY900014 | Rate of Severe Hypoglycemia | 5.87 Events per 100 participant years |
p-value: 0.83495% CI: [0.19, 3.77]Empirical method