Diabetes Mellitus, Type 1
Conditions
Brief summary
The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014, and the effect of LY900014 on blood sugar levels following a standard meal. For each participant, the study will consist of 4 periods and there will be approximately 12 weeks from screening to final study follow up.
Interventions
BIOLOGICALLY900014
Administered SC
BIOLOGICALInsulin Lispro
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1 year * Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 35.0 kg/m² * Have a glycated hemoglobin (HbA1c) ≤9.0% at screening * Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) for at least 3 months before screening with a total insulin dose demand of less than or equal to (≤) 1.5 units per kilogram per day (U/kg/day)
Exclusion criteria
* Are currently enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research * Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * Have donated blood of more than 450 millilitre (mL) or more in the last 3 months or provided any blood donation within the last month before screening. * Any significant changes in insulin regimen and/or unstable blood glucose control within the past 3 months prior to screening as assessed by the investigator. * Are treated with a CSII (insulin pump)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) | Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours) | PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve | Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose | GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm |
Countries
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study All randomized participants who received at least 1 dose of study drug. | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Washout (A Minimum of 21 Hours) | Adverse Event | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 11.3 |
| Duration of Type 1 Diabetes Mellitis | 21.41 years STANDARD_DEVIATION 13.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment Germany | 36 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 35 | 0 / 36 | 0 / 35 |
| other Total, other adverse events | 0 / 35 | 3 / 35 | 3 / 36 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 | 0 / 36 | 0 / 35 |
Outcome results
Primary
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC)
PK: Insulin Lispro AUC for Each Treatment Arm. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
Time frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, and 420 minutes (7 hours)
Population: All randomized participants who received at least 1 dose of study drug. LY900014 before and after meal and insulin lispro (Humalog) before and after meal were pooled by treatment to evaluate the overall PK of LY900014 and insulin lispro (Humalog) per protocol .
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| LY900014 | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) | 970 picomoles times hour per Liter | Geometric Coefficient of Variation 57 |
| Insulin Lispro (Humalog) | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve (AUC) | 968 picomoles times hour per Liter | Geometric Coefficient of Variation 56 |
p-value: 0.773495% CI: [0.932, 1.05]Mixed Models Analysis
Secondary
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve
GD: Area Under The Baseline Subtracted Glucose Concentration Curve for Each Treatment Arm
Time frame: Predose, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, and 300 minutes postdose
Population: All randomized participants who received at least 1 dose of study drug and had evaluable glucodynamic parameters.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LY900014 | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve | 207 milligrams times hour per deciLiter | Standard Deviation 189 |
| Insulin Lispro (Humalog) | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve | 264 milligrams times hour per deciLiter | Standard Deviation 205 |
| Insulin Lispro (Humalog) Before Meal | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve | 227 milligrams times hour per deciLiter | Standard Deviation 163 |
| Insulin Lispro (Humalog) After Meal | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve | 327 milligrams times hour per deciLiter | Standard Deviation 212 |
p-value: 0.71995% CI: [-94.38, 65.38]Mixed Models Analysis