Diabetes Mellitus, Type 1 MedDRA version: 20.0 Level: PT Classification code 10067584 Term: Type 1 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • You are diagnosed with type 1 diabetes and have been using insulin continuously for at least 12 months • You are 18 years of age or older • You are already being treated with insulin allowed for study participation. • Your blood glucose levels are within allowed limits for study participation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 581 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 51
Exclusion criteria
Exclusion criteria: • You have had more than 1 emergency treatment for very low blood glucose or poor blood glucose control in the last 6 months. • You are taking certain diabetes medications that are not allowed for study participation. • You have major problems with your heart, kidneys, liver, or you have a blood disorder. • You have had, or are now being treated for, certain types of cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To test the hypothesis that LY900014 is noninferior to Fiasp on glycemic control (NIM=0.4% for HbA1c) in patients with T1D, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin for 20 weeks;Secondary Objective: • To test the hypothesis that LY900014 is superior to Fiasp on improving glycemic control (HbA1c) when administered as prandial insulin • To compare LY900014 and Fiasp with respect to the rate of severe hypoglycemic events • To compare LY900014 and Fiasp with respect to the rate of documented symptomatic hypoglycemia • To compare LY900014 and Fiasp with respect to total, basal, and prandial insulin doses • To compare LY900014 and Fiasp with respect to 7-point SMBG profiles • To compare LY900014 and Fiasp with respect to glycemic variability • To compare LY900014 and Fiasp with respect to the proportion of patients achieving HbA1c targets • To compare LY900014 and Fiasp with respect to diabetes treatment satisfaction as measured by the ITSQ;Primary end point(s): • Difference between LY900014 and Fiasp in change from baseline to Week 20 in HbA1c;Timepoint(s) of evaluation of this end point: Week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference between LY900014 and Fiasp in change from baseline to Week 20 in HbA1c 2. Rate (events/patient/100 years) of severe hypoglycemic events from baseline to Week 20 3. Rate (events/patient/year) of documented symptomatic hypoglycemic events from baseline to Week 20 4. Change from baseline in total, basal, and prandial insulin doses and prandial/total insulin dose ratios at Week 20 5. Change from baseline in 7-point SMBG postprandial glucose excursions at Week 20 6. Within-day and between-day glycemic variability measured by the standard deviation and the coefficient of variation of 7-point SMBG profiles 7. The proportion of patients with HbA1c <7% and =6.5% at Week 20 8. Change from baseline ITSQ regimen inconvenience and lifestyle flexibility domain scores at Week 20 ;Timepoint(s) of evaluation of this end point: Week 20 for all secondary endpoints 1,2,3,4,5,7 and 8. For secondary point 6 timepoint is within-day/between-day. | — |
Countries
Austria, Canada, Czech Republic, Germany, Romania, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed