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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02221323
• Date of registration: 15/08/2014
• Prospective Registration: Yes
• Primary sponsor: Profil Institut für Stoffwechselforschung GmbH
• Public title: A Trial to Compare the PK and PD of Insulin Lispro Administered Into Different Tissues in Subjects With Diabetes Mellitus Type 1
• Scientific title: 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
• Date of first enrolment: September 2014
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02221323
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
• Phase: Phase 2

Countries of recruitment

Germany

Contacts

• Name: Ulrike Hövelmann
• Affiliation: Profil Institut für Stoffwechselforschung GmbH

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 64 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Intervention(s)

Drug: Insulin LISPRO

Primary Outcome(s)

AUCINS.0-4h and AUCGIR.0-4h [Time Frame: up to 4 hours]

Secondary ID(s)

DBC-14LIPOINJ01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors