A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1

A Trial to Compare the Pharmacokinetics and Pharmacodynamics of Insulin Lispro Administered s.c. Into Lipohypertrophic or Normal Abdominal Adipose Tissue in Subjects With Diabetes Mellitus Type 1

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02221323

Enrollment

Registered

2014-08-20

Start date

2014-09-30

Completion date

2014-11-30

Last updated

2014-12-30

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

Conditions

Diabetes Mellitus

Brief summary

The aim of this trial is to compare the pharmacokinetics and pharmacodynamics of insulin lispro injection into either lipohypertrophic lesions or normal tissue, utilizing both state-of-the-art euglycaemic clamp and mixed meal tolerance testing. The magnitude of insulin efficacy after injection into these different areas is still unclear. The results from this study may expand the knowledge on the severity of this issue and may provide evidence for future treatment recommendations regarding injection sites for insulin administration.

Interventions

DRUGInsulin LISPRO

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Inclusion criteria

* AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Exclusion criteria

* AUCINS.0-4h and AUCBG.0-4h during treatment period 2, intra-subject variability of AUCINS.0-4h and AUCGIR.0-4h during treatment period 1

Design outcomes

Primary

Measure	Time frame	Description
AUCINS.0-4h and AUCGIR.0-4h	up to 4 hours	Compare the pharmacokinetic and pharmacodynamic effects of insulin lispro during the first 4 hours after s.c. administration into either lipohypertrophic or normal adipose tissue during a euglycaemic clamp examination.

Countries

Germany

Outcome results

None listed

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