Type 1 Diabetes MedDRA version: 20.1 Level: LLT Classification code 10020639 Term: Hyperglycemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: Insulin lispro (ultra rapid formulation)
Product Code: LY900014
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN LISPRO
CAS Number: 133107-64-9
Concentration uni
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • You were diagnosed with type 1 diabetes at least one year ago. • You are 18 years old or older. • You are already using a long-acting insulin and rapid-acting insulin analog. • 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 1175 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 392
Exclusion criteria
Exclusion criteria: • You have had more than 1 emergency treatment for very low blood glucose in the last 6 months. • You have had more than 1 emergency treatment for poor 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 that prevents you from study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that LY900014 is noninferior to insulin lispro on glycemic control (non-inferiority margin [NIM]=0.4% for hemoglobin A1c [HbA1c]) in patients with T1D, when administered as prandial insulin (0 to 2 minutes prior to the meal), in combination with basal insulin glargine or insulin degludec for 26 weeks ;Secondary Objective: To test the hypothesis that LY900014 is superior to insulin lispro in controlling 1-hour PPG excursions, when administered as prandial insulin. To test the hypothesis that LY900014 is superior to insulin lispro in controlling 2-hour PPG excursions, when administered as prandial insulin. To test the hypothesis that LY900014 is superior to insulin lispro on improving glycemic control (HbA1c) when administered as prandial insulin. To test the hypothesis that LY900014 administered as postprandial insulin 20 minutes after the start of a meal, (LY900014+20), is noninferior to insulin lispro, administered as prandial insulin, on glycemic control (NIM=0.4% for HbA1c);Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Difference between LY900014 and insulin lispro in the 1-hour PPG excursion (serum glucose measured 1 hour after the start of the meal minus fasting serum glucose) from a MMTT. 2. Difference between LY900014 and insulin lispro in the 2-hour PPG excursion (serum glucose measured 2 hours after the start of the meal minus fasting serum glucose) from an MMTT. 3. Difference between LY900014 and insulin lispro in change from baseline in HbA1c 4. Difference between LY900014+20 and insulin lispro in change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: 1. 26 weeks 2. 26 weeks 3. 26 weeks 4. 26 weeks | — |
Countries
Argentina, Australia, Austria, Brazil, Germany, Greece, India, Italy, Japan, Mexico, New Zealand, Poland, Romania, Russian Federation, Slovakia, Spain, Sweden, Taiwan, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed