Type 2 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 2 diabetes (T2D).
Interventions
DRUGInsulin Glargine
Administered SC
DRUGInsulin Degludec
Administered SC
DRUGLY900014
Administered SC
DRUGInsulin Lispro
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 T2D based on the disease diagnostic criteria World Health Organization (WHO) classification. * Participants must have been treated for at least 90 days prior to screening with either basal insulin + at least 1 prandial injection of bolus insulin or premixed analog/human insulin regimens at least twice daily. * Participants must be treated no more than 3 oral anti-hyperglycemic medications (OAMs). * Participants must have a HbA1c ≥7.0% and ≤11.0%. * Participants must have body mass index (BMI) of ≤35.0 kilograms per meter squared (kg/m2).
Exclusion criteria
* Participants must not have been diagnosed, at any time, with type 1 diabetes (T1D) or latent autoimmune diabetes in adults. * Participants must not have had any episode of severe hypoglycemia within the 6 months prior to screening. * Participants must not have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. * Participants must not have used thiazolidinediones, glucagon-like peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days 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. HbA1c 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). |
| 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. |
| Rate of Documented Symptomatic Postmeal Hypoglycemia | Baseline through Week 26 | Documented symptomatic postmeal 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 postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable |
| 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. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares). |
| Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Baseline, Week 26 | SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares). |
| Change From Baseline in Insulin Dose | Baseline, Week 26 | LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) |
| Percentage of Participants With HbA1c <7% and ≤6.5% | Week 26 | Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis. |
| 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. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares) |
Countries
Argentina, China, Mexico
Participant flow
Recruitment details
The study included 8-week lead-in period followed by a 26-week treatment period.
Pre-assignment details
The purpose of the lead-in period (prior to randomization) was to titrate basal insulin, obtain preliminary diagnostic laboratory tests, and determine baseline hypoglycemia rates. Participants were then randomized into the treatment groups in a 2:1 ratio (LY900014:insulin lispro).
Participants by arm
| Arm | Count |
|---|---|
| Insulin Lispro (Humalog) Participants received 100 units per milliliter (U/mL) insulin lispro (Humalog) subcutaneously (SC) 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 200 |
| LY900014 Participants received 100 U/mL LY900014 by SC 0-2 minutes before each meal with either basal insulin glargine or insulin degludec given SC once daily. | 395 |
| Total | 595 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Lead-In Period | Adverse Event | 2 | 0 | 0 |
| Lead-In Period | Lack of Efficacy | 2 | 0 | 0 |
| Lead-In Period | Physician Decision | 5 | 0 | 0 |
| Lead-In Period | Protocol Violation | 5 | 0 | 0 |
| Lead-In Period | Withdrawal by Subject | 19 | 0 | 0 |
| Treatment Period | Adverse Event | 0 | 0 | 1 |
| Treatment Period | Due to COVID 19 restrictions | 0 | 2 | 5 |
| Treatment Period | Lost to Follow-up | 0 | 2 | 0 |
| Treatment Period | Participant had taken prohibited concomitant medication | 0 | 0 | 1 |
| Treatment Period | Physician Decision | 0 | 0 | 2 |
| Treatment Period | Protocol Violation | 0 | 0 | 1 |
| Treatment Period | Withdrawal by Subject | 0 | 5 | 26 |
Baseline characteristics
| Characteristic | LY900014 | Total | Insulin Lispro (Humalog) |
|---|---|---|---|
| Age, Continuous | 58.30 years STANDARD_DEVIATION 9.26 | 58.50 years STANDARD_DEVIATION 9.33 | 58.70 years STANDARD_DEVIATION 9.48 |
| Hemoglobin A1c (HbA1c) | 7.73 Percentage of HbA1c STANDARD_DEVIATION 0.87 | 7.74 Percentage of HbA1c STANDARD_DEVIATION 0.88 | 7.78 Percentage of HbA1c STANDARD_DEVIATION 0.88 |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 16 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 319 Participants | 481 Participants | 162 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 12 Participants | 16 Participants | 4 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 | 53 Participants | 82 Participants | 29 Participants |
| Region of Enrollment Argentina | 32 Participants | 50 Participants | 18 Participants |
| Region of Enrollment China | 319 Participants | 481 Participants | 162 Participants |
| Region of Enrollment Mexico | 44 Participants | 64 Participants | 20 Participants |
| Sex: Female, Male Female | 182 Participants | 275 Participants | 93 Participants |
| Sex: Female, Male Male | 213 Participants | 320 Participants | 107 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 628 | 1 / 200 | 0 / 395 |
| other Total, other adverse events | 29 / 628 | 14 / 200 | 21 / 395 |
| serious Total, serious adverse events | 17 / 628 | 15 / 200 | 33 / 395 |
Outcome results
Primary
Change From Baseline in Hemoglobin A1c (HbA1c)
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c 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).
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) | -0.63 Percentage of HbA1c | Standard Error 0.061 |
| LY900014 | Change From Baseline in Hemoglobin A1c (HbA1c) | -0.56 Percentage of HbA1c | Standard Error 0.046 |
p-value: 0.32195% CI: [-0.07, 0.21]Mixed Models Analysis
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. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
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) | 100.8 milligrams per deciliter (mg/dL) | Standard Error 4 |
| LY900014 | 1-hour Postprandial Glucose (PPG) Excursion During Mixed-Meal Tolerance Test (MMTT) | 86.2 milligrams per deciliter (mg/dL) | Standard Error 3.51 |
p-value: <0.00195% CI: [-21.9, -7.4]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. Least Squares (LS) mean was determined by analysis of covariance (ANCOVA) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment (Type III sum of squares).
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 | 133.2 mg/dL | Standard Error 5.13 |
| LY900014 | 2-hour PPG Excursion During MMTT | 111.4 mg/dL | Standard Error 4.47 |
p-value: <0.00195% CI: [-30.9, -12.6]ANCOVA
Secondary
Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values
SMBG 10-point profiles were measured at fasting, 1-hour post morning meal, 2-hours post morning meal, pre midday meal, 1-hour post midday meal, 2-hours post midday meal, pre evening meal, 1-hour post evening meal, 2-hours post evening meal, and bedtime. LS Mean was analyzed using mixed model repeated measures (MMRM) model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares).
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 | 2.2 mg/dL | Standard Error 2.62 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 1-hour Postmeal | -12.9 mg/dL | Standard Error 3.77 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 2-hour Postmeal | -15.9 mg/dL | Standard Error 3.65 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday Premeal | -9.8 mg/dL | Standard Error 3.09 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 1-hour Postmeal | -15.2 mg/dL | Standard Error 3.52 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 2-hour Postmeal | -24.4 mg/dL | Standard Error 3.63 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening Premeal | -25.0 mg/dL | Standard Error 3.34 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 1-hour Postmeal | -17.6 mg/dL | Standard Error 3.65 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 2-hour Postmeal | -22.1 mg/dL | Standard Error 3.67 |
| Insulin Lispro (Humalog) | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Bedtime | -22.3 mg/dL | Standard Error 3.38 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 1-hour Postmeal | -15.6 mg/dL | Standard Error 3.06 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning Premeal | 4.4 mg/dL | Standard Error 2.18 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 2-hour Postmeal | -22.5 mg/dL | Standard Error 3.02 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 1-hour Postmeal | -18.1 mg/dL | Standard Error 3.13 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Bedtime | -20.7 mg/dL | Standard Error 2.82 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Morning 2-hour Postmeal | -21.3 mg/dL | Standard Error 3.02 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening Premeal | -10.9 mg/dL | Standard Error 2.76 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday Premeal | -5.7 mg/dL | Standard Error 2.56 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Evening 2-hour Postmeal | -22.3 mg/dL | Standard Error 3.05 |
| LY900014 | Change From Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values | Midday 1-hour Postmeal | -13.9 mg/dL | Standard Error 2.92 |
Comparison: For Morning Premeal95% CI: [-2.8, 7.2]
Comparison: For Morning 1-hour Postmeal95% CI: [-12.6, 2]
Comparison: For Morning 2-hour Postmeal95% CI: [-12.5, 1.7]
Comparison: For Midday Premeal95% CI: [-1.8, 10.1]
Comparison: For Midday 1-hour Postmeal95% CI: [-5.7, 8.1]
Comparison: For Midday 2-hour Postmeal95% CI: [-5.1, 8.9]
Comparison: For Evening Premeal95% CI: [7.6, 20.6]
Comparison: For Evening 1-hour Postmeal95% CI: [-5.1, 9.1]
Comparison: For Evening 2-hour Postmeal95% CI: [-7.3, 6.8]
Comparison: For Bedtime95% CI: [-4.7, 8.1]
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. 1,5-AG accurately predicts rapid changes in glycemia and is tightly associated with glucose fluctuations and postprandial glucose. LS Mean was calculated using mixed model repeated measures (MMRM) with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares)
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) | 2.49 milligram per liter (mg/L) | Standard Error 0.363 |
| LY900014 | Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) | 2.21 milligram per liter (mg/L) | Standard Error 0.28 |
95% CI: [-1.1, 0.53]
Secondary
Change From Baseline in Insulin Dose
LS mean was determined by MMRM model with Baseline + Pooled Country + Hemoglobin A1c Stratum at Baseline + Number of Bolus at Study Entry Stratum + Type of Basal at Lead-in Stratum + Treatment + Time + Treatment\*Time (Type III sum of squares)
Time frame: Baseline, Week 26
Population: All randomized participants with baseline and at least one post-baseline basal insulin dose data.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro (Humalog) | Change From Baseline in Insulin Dose | Total Daily Insulin Dose | 15.1 Units (U) | Standard Error 1.13 |
| Insulin Lispro (Humalog) | Change From Baseline in Insulin Dose | Daily Basal Insulin Dose | 0.7 Units (U) | Standard Error 0.34 |
| Insulin Lispro (Humalog) | Change From Baseline in Insulin Dose | Daily Prandial Insulin Dose | 14.7 Units (U) | Standard Error 1.04 |
| LY900014 | Change From Baseline in Insulin Dose | Total Daily Insulin Dose | 17.8 Units (U) | Standard Error 0.82 |
| LY900014 | Change From Baseline in Insulin Dose | Daily Basal Insulin Dose | 1.4 Units (U) | Standard Error 0.26 |
| LY900014 | Change From Baseline in Insulin Dose | Daily Prandial Insulin Dose | 16.7 Units (U) | Standard Error 0.75 |
Comparison: For Total Daily Insulin Dose95% CI: [0.1, 5.4]
Comparison: For Daily Basal Insulin Dose95% CI: [0, 1.5]
Comparison: For Daily Prandial Insulin Dose95% CI: [-0.5, 4.5]
Secondary
Percentage of Participants With HbA1c <7% and ≤6.5%
Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Only subjects with non-missing baseline value and at least one non-missing post-baseline value of the response variable were included in analysis.
Time frame: Week 26
Population: All randomized participants with baseline and at least one post-baseline HbA1c \<7% and ≤6.5% data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Insulin Lispro (Humalog) | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c < 7% | 44.50 Percentage of participants |
| Insulin Lispro (Humalog) | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c ≤ 6.5% | 27.23 Percentage of participants |
| LY900014 | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c < 7% | 46.65 Percentage of participants |
| LY900014 | Percentage of Participants With HbA1c <7% and ≤6.5% | HbA1c ≤ 6.5% | 27.93 Percentage of participants |
Comparison: For HbA1c \< 7%p-value: 0.92495% CI: [0.69, 1.52]Regression, Logistic
Comparison: For HbA1c ≤6.5%p-value: 0.90895% CI: [0.64, 1.49]Regression, Logistic
Secondary
Rate of Documented Symptomatic Postmeal Hypoglycemia
Documented symptomatic postmeal 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 postmeal hypoglycemia was estimated by negative binomial model: number of episodes = treatment with log (treatment exposure in days/365.25) as an offset variable
Time frame: Baseline through Week 26
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤30 minutes post meal | 0.13 Events per participant per year | Standard Error 0.033 |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤1 hour post meal | 0.25 Events per participant per year | Standard Error 0.057 |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Postmeal Hypoglycemia | >1 to ≤2 hours post meal | 0.67 Events per participant per year | Standard Error 0.109 |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤2 hours post meal | 0.92 Events per participant per year | Standard Error 0.137 |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Postmeal Hypoglycemia | >2 to ≤4 hours post meal | 1.96 Events per participant per year | Standard Error 0.276 |
| Insulin Lispro (Humalog) | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤4 hours post meal | 2.89 Events per participant per year | Standard Error 0.351 |
| LY900014 | Rate of Documented Symptomatic Postmeal Hypoglycemia | >2 to ≤4 hours post meal | 1.92 Events per participant per year | Standard Error 0.214 |
| LY900014 | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤30 minutes post meal | 0.11 Events per participant per year | Standard Error 0.02 |
| LY900014 | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤2 hours post meal | 1.41 Events per participant per year | Standard Error 0.169 |
| LY900014 | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤1 hour post meal | 0.34 Events per participant per year | Standard Error 0.053 |
| LY900014 | Rate of Documented Symptomatic Postmeal Hypoglycemia | ≤4 hours post meal | 3.32 Events per participant per year | Standard Error 0.336 |
| LY900014 | Rate of Documented Symptomatic Postmeal Hypoglycemia | >1 to ≤2 hours post meal | 1.07 Events per participant per year | Standard Error 0.145 |
Comparison: For ≤30 minutes post meal95% CI: [0.49, 1.66]
Comparison: For ≤ 1 hour post meal95% CI: [0.79, 2.31]
Comparison: For \>1 to ≤2 hours post meal95% CI: [1.06, 2.42]
Comparison: For ≤2 hours post meal95% CI: [1.05, 2.23]
Comparison: For \>2 to ≤4 hours post meal95% CI: [0.69, 1.39]
Comparison: For ≤4 hours post meal95% CI: [0.84, 1.57]
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.
Time frame: Baseline through Week 26
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Insulin Lispro (Humalog) | Rate of Severe Hypoglycemia | 2.00 Events per 100 participant years |
| LY900014 | Rate of Severe Hypoglycemia | 0.52 Events per 100 participant years |
95% CI: [0.02, 2.86]