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

Profil Institut für Stoffwechselforschung

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus

Treatments: Drug: Insulin LISPRO

Study type: Interventional

Funder types: Industry

Identifiers

NCT02221323

DBC-14LIPOINJ01

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Insulin lispro

Experimental group

Treatment:

Drug: Insulin LISPRO