Safety/Efficacy Study of Subcutaneously Injected Prandial Insulins Compared to Insulin Lispro Alone in Participants With Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Type 1 diabetes
Eligibility Criteria
Inclusion Criteria:
- Males or females aged ≥18 years
- Type 1 Diabetes Mellitus (T1DM) treated with insulin for ≥12 months
- Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2).
- Hemoglobin A1C (HbA1C) level 6.7% to 8.2%, inclusive
- Fasting C-peptide <0.6 nanograms per milliliter (ng/mL)
- Willingness to use twice daily (BID) insulin glargine 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
Exclusion Criteria:
- Known or suspected allergy to any component of any of the study drugs
- Use of pramlintide within 30 days of Screening
- Use of drugs during the study or within 30 days of Screening (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
- Recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the Investigator
Sites / Locations
- AMCR Institute, Inc.
- Scripps Whittier Diabetes Institute
- Mills-Peninsula Health Services
- Barbara Davis Center for Childhood Diabetes
- Center for Diabetes and Endocrine Care
- Diabetes Research Institute
- Rocky Mountain Diabetes and Osteoporosis Center
- Mid-America Diabetes Associates
- Tulane University Health Sciences Center
- Medstar Research Institute
- Henry Ford Health System
- International Diabetes Center
- Mercury Street Medical
- Desert Endocrinology
- UT Southwestern Medical Center at Dallas
- Texas Diabetes and Endocrinology
- Cetero Research-San Antonio
- West Olympia Internal Medicine
- University of Washington School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Lispro-PH20 / Insulin Lispro
Aspart-PH20 / Insulin Lispro
All enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.
All enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Next participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle with no washout period. Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.