At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years at screening
- ✓Diagnosed with Type 1 diabetes per ADA criteria
- ✓HbA1c >7% and <10% at screening
- ✓Fasting C-peptide <0.7 ng/mL
- ✕Severe symptomatic hypoglycemia with seizure or requiring external help in past 6 months
- ✕MI, unstable angina, revascularization, or CVA ≤12 weeks before screening
- ✕NYHA Class III-IV cardiac disease history
- ✕Hemoglobin <10.0 g/dL or known hemoglobinopathies
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy, Safety, and Pharmacodynamics of Multiple Doses of REMD-477 in Subjects With Type 1 Diabetes Mellitus
In Brief
A Phase 2 clinical trial evaluating REMD-477 and Placebo Comparator for Type1 Diabetes Mellitus. Completed, enrolled 154 participants across 11 sites.
Detailed Summary
This is a randomized, placebo-controlled, double-blind study to evaluate the efficacy, safety, and pharmacodynamics (PD) of multiple doses of REMD-477 in subjects who have Type 1 diabetes and are currently receiving insulin treatment. This study will determine whether REMD-477 can decrease daily insulin requirements and improve glycemic control after 12 weeks of treatment in subjects diagnosed with Type 1 diabetes with fasting C-peptide \< 0.7 ng/mL at Screening. The study will be conducted at multiple sites in the United States. Approximately 150 subjects with type 1 diabetes on stable doses of insulin will be randomized in a 1:1:1 fashion into one of three treatment groups.
Study Details
Timeline
Interventions
Administered as repeated SC doses in subjects with Type 1 Diabetes
Administered as a repeated SC doses in subjects with Type 1 Diabetes