Diabetes Mellitus, Type 2
Conditions
Brief summary
The study will be conducted in participants with type 2 diabetes on insulin injection therapy to investigate how the body processes a test formulation of insulin lispro and the effect of the test formulation on blood sugar levels. Side effects and tolerability will be documented. The study will be conducted in two parts (Part A and Part B) to achieve its objectives. Participants are expected to enroll in both parts.
Interventions
DRUGInsulin Lispro
Administered subcutaneously (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 2 Diabetes Mellitus (T2DM) * Are on stable prandial insulin as a multiple daily injection regimen, plus/minus basal insulin, with or without a stable dose of metformin, for at least 3 months before screening * Have a body mass index (BMI) no greater than 35.0 kilogram per square meter (kg/m²) * Have blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results 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 enrolled, or have participated within the last 30 days, in a clinical trial or any other type of medical research judged to be incompatible with this study * Have previously completed or withdrawn from this study * Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * Had blood loss of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 * Are treated with a continuous subcutaneous insulin infusion (insulin pump)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro | Time 0 to 5 hours post dose for each treatment on Day 1 | (Part A) PK: AUC of Insulin Lispro |
| (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal | Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment | (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal | Time 0 to 5 hours post meal for each treatment on Day 1 | (Part A) PD: AUC of Glucose Following a Meal |
| (Part B) PD: AUC of Glucose Following a Meal | Time 0 to 5 hours post meal on Day1 and Day14 of study treatment | (Part B) PD: AUC of Glucose Following a Meal |
Outcome results
None listed