Diabetes Mellitus, Type 2
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 will last 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
* Have a body mass index (BMI) of 18.5 kilogram per meter square (kg/m²) to 40.0 kg/m² * Have a glycated hemoglobin (HbA1c) less than or equal to (≤)9.0% * Have a fasting C-peptide ≤1.0 nanomole per liter (nmol/L) * Are on stable prandial insulin and basal insulin (neutral protamine Hagedorn \[NPH\] insulin, insulin glargine or insulin detemir) with or without a stable dose of metformin for at least 3 months before screening
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) * Require daily insulin treatment greater than (\>)1.2 units per kilogram per body weight (U/kg/body weight)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr) | Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose | PK: Insulin Lispro AUC for Each Treatment Arm. 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 (BGΔAUC) for Each Treatment Arm | -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal | GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) 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 |
|---|---|---|---|---|---|
| Period 1 | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 60.8 years STANDARD_DEVIATION 6.6 |
| Duration of T2DM | 16.704 years STANDARD_DEVIATION 8.957 |
| 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 | 0 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 | 36 Participants |
| Region of Enrollment Germany | 36 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 31 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 / 36 | 0 / 35 | 0 / 35 |
| other Total, other adverse events | 1 / 35 | 2 / 36 | 1 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 36 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr)
PK: Insulin Lispro AUC for Each Treatment Arm. 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, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, and 420 minutes (7 hours) postdose
Population: All randomized participants who received at least 1 dose of study drug and evaluable PK data. 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 Zero to Seven Hours (AUC0-7hr) | 1320 picomol times hour per Liter | Geometric Coefficient of Variation 63 |
| Insulin Lispro (Humalog) | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve Zero to Seven Hours (AUC0-7hr) | 1240 picomol times hour per Liter | Geometric Coefficient of Variation 68 |
Secondary
Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
GD: Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm
Time frame: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, and 300 minutes post-meal
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 (BGΔAUC) for Each Treatment Arm | 97.8 milligrams times hour per deciliter | Standard Deviation 155 |
| Insulin Lispro (Humalog) | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | 112 milligrams times hour per deciliter | Standard Deviation 139 |
| Insulin Lispro (Humalog) Before Meal | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | 131 milligrams times hour per deciliter | Standard Deviation 155 |
| Insulin Lispro (Humalog) After Meal | Glucodynamics (GD): Area Under the Baseline Subtracted Glucose Concentration Curve (BGΔAUC) for Each Treatment Arm | 146 milligrams times hour per deciliter | Standard Deviation 150 |
95% CI: [0.42, 1.16]
95% CI: [0.49, 1.01]