Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Halozyme Therapeutics
Criteria for randomization into the study included 1) fasting blood glucose and pre-dinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dL) approximately 60% of the time for 7 days prior to randomization; 2) 90 minute or 2-hour postprandial blood glucose \<220 mg/dL approximately 70% of the time for 7 days prior to randomization; and 3) successfully completing 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. Participants that did not meet 1 or more of these criteria during a 4- to 6-week Titration Period were not randomized.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males or females ≥18 years
Type 2 diabetes mellitus (T2DM) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months
Body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m\^2)
Glycosylated hemoglobin (HbA1C) level 7.0 to 8.5%, inclusive
Fasting C-peptide \<0.6 nanograms per milliliter (ng/mL)
Willingness to use insulin glargine twice a day as basal insulin for the duration of the study
Willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (CGM) during the study
You may not be if
Known or suspected allergy to any component of any of the study drugs
Exclusive use of pre-mixed insulins
Use of pramlintide, exenatide, and/or liraglutide within 30 days of screening
Use of sulfonylureas within two months of screening
Use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening
Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator
Clareo Health | Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Patients With Type 2 Diabetes Mellitus
