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About
The study is a prospective, randomized, double-blind, placebo-controlled, multi-center trial in subjects with new onset T1D.
Full description
The study will include 210 male or female subjects aged 12 to 35 years diagnosed with T1D, as defined by the American Diabetes Association (ADA) criteria and meeting enrollment criteria as follows. Initial enrollment will be restricted to subjects aged 18 and older until an analysis of data from subjects with 3 months' exposure to drug confirms safety. Upon completion of this assessment, enrollment will be open without further restrictions for subjects aged 12-35.
Sex
Ages
Volunteers
Inclusion criteria
Diagnosis of Type 1 Diabetes Mellitus based on American Diabetes Association (ADA) criteria and ≤100 days since diagnosis, defined as the first day of insulin administration (subjects must be able to be randomized within the 100-day period from diagnosis) .
Adequate glycemic control for >14 days, defined as 3 consecutive fasting glucose levels by self-administered blood glucose (SMBG) or lab testing at <130 mg/dL.
Age at randomization of 12.0 - <18.0 years (adolescent), 18.0 - <36.0 years of age (adult) ..
HbA1c <10.0% based on point-of-care or local lab measurement.
• Measurement can be repeated every 5-7 days if >10.0%.
Presence of antibodies to at least one of the following antigens: GAD-65, IA-2, ZnT8; or insulin, if obtained within 10 days of the onset of exogenous insulin therapy.
Willingness to wear a continuous glucose monitoring (CGM) device for specified periods of time.
Written informed consent, including authorization to release health information and assent for adolescent subjects.
Willingness and ability of subject or adult guardian to comply with all study procedures of the study protocol, including attending all clinic visits.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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