A Study of a Novel Insulin Lispro Formulation in Participants With Type 1 Diabetes Mellitus Using Insulin Pumps

Pharmacokinetics, Glucodynamics, Safety, and Tolerability of a Novel Insulin Lispro Formulation in Patients With Type 1 Diabetes Mellitus on Continuous Subcutaneous Insulin Infusion Therapy

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02623478

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

This study evaluates a new test formulation of a glucose lowering drug, insulin lispro, delivered by an insulin pump continuously under the skin. The study will be conducted in participants with type 1 diabetes mellitus to investigate how the human body processes the new test formulation and its effect on blood sugar levels when it is delivered via an insulin pump. Side effects and tolerability will be documented. The study will last about 4 to 11 weeks, including screening, lead-in and follow up. Screening is required within 28 days prior to entering the study.

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

* 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): Area under the Concentration Curve (AUC) of Insulin Lispro	Time 0 to 5 hours post dose on Day 1 and Day 3 of each study period	PK: AUC of Insulin Lispro

Secondary

Measure	Time frame	Description
Pharmacodynamics (PD): AUC of Glucose Following a Meal	Time 0 to 5 hours post meal on Day 1 and Day 3 of each of study period	PD: AUC of Glucose Following a Meal

Outcome results

None listed

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