Clinical trial NCT02623465: A Study of a New Type of Insulin in Participants With Type 2 Diabetes on Insulin Injection Therapy
Official title: Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 2 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-12-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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* Have previously completed or withdrawn from this study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)

Primary outcomes:
measure: (Part A) Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Insulin Lispro
timeFrame: Time 0 to 5 hours post dose for each treatment on Day 1
measure: (Part B) PK: AUC of Insulin Lispro Glucose Following a Mixed Meal
timeFrame: Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment
Secondary outcomes:
measure: (Part A) Pharmacodynamics (PD): AUC of Glucose Following a Meal
timeFrame: Time 0 to 5 hours post meal for each treatment on Day 1
measure: (Part B) PD: AUC of Glucose Following a Meal
timeFrame: Time 0 to 5 hours post meal on Day1 and Day14 of study treatment
Other outcomes:
Locations:
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: