A Study of a New Type of Insulin in Participants With Type 1 Diabetes on Insulin Injection Therapy

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02623452

Enrollment

Registered

2015-12-07

Start date

2018-01-31

Completion date

2018-04-30

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

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.

Interventions

DRUGInsulin Lispro

Administered subcutaneously (SC)

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

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trial or any other type of medical research judged to be incompatible with this study * Have previously completed or withdrawn from this study * Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate in the study * Had blood loss of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)

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	Time 0 to 5 hours post dose on Day 1 and Day 14 of study treatment	(Part B) PK: AUC of Insulin Lispro

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

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026