Status and phase
Conditions
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Study type
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Identifiers
About
The main purpose of this study is to evaluate the efficacy and safety of the study drug known as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes mellitus.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Diagnosed with type 2 diabetes mellitus (T2DM).
Current TDD >200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry.
HbA1c ≥7.5% and ≤12.0%.
Body mass index ≥25 but ≤50 kilograms per meter squared.
Have a history of stable body weight.
Concomitant antihyperglycemic agent (AHA) therapy may include metformin (MET), dipeptidyl peptidase-4 inhibitors and/or pioglitazone.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
420 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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