Diabetes Mellitus, Type 1
Conditions
Brief summary
This study evaluated a blood sugar lowering insulin, LY900014, delivered by an insulin pump continuously under the skin. The study was conducted in participants with type 1 diabetes mellitus to investigate how the human body processed LY900014 and its effect on blood sugar levels when it was delivered via an insulin pump. Side effects and tolerability were be documented.
Interventions
DRUGLY900014
Administered subcutaneously (SC)
DRUGInsulin 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 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female participants with Type 1 Diabetes Mellitus (T1DM) who are receiving insulin therapy via an approved insulin pump * Have a body mass index (BMI) of 18.5 to 33 kilogram per square meter (kg/m²), inclusive, at screening * Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study * Have had no episodes of severe hypoglycemia in the past 6 months (requiring assistance in treatment by a second party) * Have venous access sufficient to allow for blood sampling * Have provided written consent and are willing to follow study procedures and commit to the study duration
Exclusion criteria
* Are currently participating in or completed a clinical trial within the last 30 days from a clinical trial or any other type of medical research judged to be incompatible with this study * Have previously participated or withdrawn from this study * Have or used to have health problems, laboratory test results, blood pressure or ECG readings that, in the opinion of the doctor, could make it unsafe to participate in the study * Had blood loss of more than 500 milliliters (mL) within the last month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) | Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment | PK: Insulin Lispro AUC(0-5h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment | PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) |
Countries
Germany
Participant flow
Pre-assignment details
This study compared individualized doses of LY900014 (Test) to insulin lispro (Reference) when delivered via an insulin pump. The study consisted of four, three-day treatment periods, with a maximum of one week between doses in consecutive periods.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Individualized doses of LY900014 (Test) or insulin lispro (Reference) delivered via an insulin pump as a continuous SC infusion with intermittent bolus doses immediately before meals in four, three-day periods. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Period Two | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 42.6 years STANDARD_DEVIATION 12.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 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 | 30 Participants |
| Region of Enrollment Germany | 30 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 4 / 29 | 3 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 30 |
Outcome results
Primary
Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h])
PK: Insulin Lispro AUC(0-5h)
Time frame: Days 1 and 3: -15, 0, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300 minutes post dose for each treatment
Population: All participants who received both study drugs and had evaluable PK data. For one participant in the Insulin Lispro - Reference group, the insulin lispro PK profile (Period Two, Day 3) was excluded from the mean PK analysis, as there was no absorption phase observed.
| Arm | Measure | Group | Value (GEOMETRIC_LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro - Reference | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) | Day 1 | 918 picomole*hour per liter (pmol•h/L) | Geometric Coefficient of Variation 26 |
| Insulin Lispro - Reference | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) | Day 3 | 906 picomole*hour per liter (pmol•h/L) | Geometric Coefficient of Variation 30 |
| LY900014 - Test | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) | Day 1 | 970 picomole*hour per liter (pmol•h/L) | Geometric Coefficient of Variation 28 |
| LY900014 - Test | Pharmacokinetics (PK): Insulin Lispro Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) | Day 3 | 824 picomole*hour per liter (pmol•h/L) | Geometric Coefficient of Variation 37 |
Secondary
Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
PD: AUC(0-5h) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT)
Time frame: Days 1 and 3: -30, -15, 0, 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 120, 135, 150, 165, 180, 195, 210, 225, 240, 300 minutes post dose for each treatment
Population: All participants who received study drug and had evaluable PD data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Insulin Lispro - Reference | Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Day 1 | 584 milligram*hour/deciliter (mg*h/dL) | Standard Deviation 175 |
| Insulin Lispro - Reference | Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Day 3 | 551 milligram*hour/deciliter (mg*h/dL) | Standard Deviation 185 |
| LY900014 - Test | Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Day 3 | 628 milligram*hour/deciliter (mg*h/dL) | Standard Deviation 210 |
| LY900014 - Test | Pharmacodynamics (PD): Area Under the Concentration Curve From Time Zero to 5 Hours (AUC[0-5h]) of Glucose Relative to a Mixed Meal Tolerance Test (MMTT) | Day 1 | 567 milligram*hour/deciliter (mg*h/dL) | Standard Deviation 172 |