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Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)

NCT02914886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2024-10-15

No results posted yet for this study

Summary

The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy.

Conditions

Interventions

DRUG

Apidra

Half of patients with lipoatrophy will be switched randomly to insulin Apidra for 12 months. Any site other than the lipoatrophic site would be used for delivering the insulin for the purpose of this study.

DRUG

current insulin

Half of patients with lipoatrophy will still use their current Insulin for 6 months. After 6 months the current insulin will be switched to insulin Apidra for the next 6 months.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Kinderkrankenhaus auf der Bult

    lead OTHER

Principal Investigators

  • Olga Kordonouri, MD · Kinder- und Jugendkrankenhaus AUF DER BULT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-04-30
Completion
2019-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914886 on ClinicalTrials.gov