Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes
DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective
is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in
insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed
meal-stimulated C-peptide.
Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3
otelixizumab, 1/3 placebo). These study agents will be administered as an addition to
insulin, diet, and other standard of care treatments.
The following visits are required:
- Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2
of these visits participants will drink a liquid meal and have blood tests done over the
post-meal period. Participants will also be required to wear a continuous glucose
monitor for a short period of time.
- Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 2-4 hours.
- Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed
by monthly visits through 1 year. There will be 3 visits in the second year.
- The total duration of the study is 2 years.
- Glucose test strips and glucose monitors will be provided to participants for the
duration of the study. Frequent glycemic monitoring will occur through lab testing and
blood glucose self-monitoring to help facilitate tight glycemic control in all subjects.
Subjects will be asked to intermittently record their insulin doses using a telephone or
web based system and continuous glucose monitoring will be performed every 6 months.
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