A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection Therapy
- Registration Number
- NCT02623452
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The study will be conducted in participants with type1 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Are male or female participants with type 1 diabetes mellitus (T1DM) on a stable multiple daily injection regimen with a short-acting as well as a long-acting insulin
- Have a body mass index (BMI) ranging from 18.5 to 33.0 kilogram per square meter (kg/m²), inclusive, at screening
- 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- Have previously completed or withdrawn from this study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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part A:Insulin Lispro Reference Insulin Lispro Individualized doses of Insulin Lispro reference formulation administered by injection under the skin once in each of 3 periods Part A:Insulin Lispro Test Insulin Lispro Individualized doses of Insulin Lispro test formulation administered by injection under the skin once in each of 3 periods Part B:Insulin Lispro Test Insulin Lispro Individualized doses of Insulin Lispro test formulation administered by injection under the skin with each meal for 14 days Part B:Insulin Lispro Reference Insulin Lispro Individualized doses of Insulin Lispro reference formulation administered by injection under the skin with each meal for 14 days
- Primary Outcome Measures
Name Time Method (Part B) PK: AUC of Insulin Lispro Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment (Part B) PK: AUC of Insulin Lispro
(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
- Secondary Outcome Measures
Name Time Method (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