Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT00645840|
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Drug: Anakinra||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory, Open Label Study of Anti-inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type 1 Diabetes Mellitus|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
After study enrollment, all subjects started anakinra (Kineret™; Amgen, Thousand Oaks, CA, USA) as a subcutaneous daily injection. Subjects weighing >25 kg at the time of enrollment received 100 mg daily, whereas those weighing <25 kg received 50 mg daily. Anakinra was continued for 28 d with no dose adjustment.
Patients will receive daily anakinra therapy for 28 days
Other Name: Kineret
- Effect of Anakinra Treatment on PBMC Gene Expression for Patients [ Time Frame: 1 month ]Expression data at baseline and after treatment were available on 10 patients who had received anakinra. These were compared to similarly-timed samples from 10 patients from control group B. Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed.
- C-peptide Secretory Capacity [ Time Frame: 7 months ]Mixed-meal tolerance tests. MMTTs were conducted at the UT Southwestern Clinical Translational Research Center (CTRC). Subjects underwent MMTTs at 3-4 wk after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed by Dr Philip Raskin (UTSouthwestern MedicalCenter, Dallas, TX,USA). C-peptide AUC was calculated for each MMTT using the trapezoidal method. C-peptide AUC data between groups were rank transformed and then analyzed using a two-way repeated measures analysis of variance (ANOVA).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00645840
|United States, Texas|
|Children's Medical Center|
|Dallas, Texas, United States, 75235|
|Principal Investigator:||Soumya Adhikari, MD||UT Southwestern Medical Center|