Type 1 Diabetes Mellitus MedDRA version: 16.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: LY2605541
Product Code: LY2605541
Pharmaceutical Form: Solution for injection in pre-filled pen
Current Sponsor code: LY2605541
Other descriptive name: LY2605541
Concentration unit: U/ml
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Have had T1DM based on the World Health Organization (WHO) classification [2] Are at least 18 years of age [3] Duration of diabetes = 1 year [4] Have an HbA1c value =65 years) yes F.1.3.1 Number of subjects for this age range 22
Exclusion criteria
Exclusion criteria: [12] Are using twice daily insulin glargine having been inadequately controlled on single daily dosed glargine prior to screening. [13] Excessive insulin resistance defined as having received a total daily dose of insulin > 1.5 U/kg at the time of randomization. [14] Receiving any oral or injectable medication (other than metformin for treatment of polycystic ovarian disease) intended for the treatment of diabetes mellitus other than insulins in the 90 days prior to screening. Note: for subjects on metformin, the following exclusion criteria will apply: have serum creatinine concentration that contraindicates metformin use per the country-specific product labeling; [15] Lipid-lowering medications: are using niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or are using lipid lowering medication at a dose that has not been stable for = 90 days prior to screening. If the patient has not been on a stable dose of lipid-lowering medication for = 90 days prior to screening, the site should wait to screen the patient. If the results of the screening laboratory tests require a change to the patient’s current lipid-lowering medication or initiation of lipid-lowering medication for the patient and have the patient return = 90 days later to complete some of the screening procedures again. [16] Have fasting hypertriglyceridemia (defined as >4.5 mmol/L, 2.5 mg/dL. [21] Hepatic: have obvious clinical signs or symptoms of liver disease (excluding non-alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements of: total bilirubin (=2 x ULN), or alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) >2.5x ULN as defined by the central laboratory or aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) > 2.5 x ULN as defined by the central laboratory. [22] Malignancy: have active or untreated malignancy, have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator. [23] Allergy: have known hypersensitivity or allergy to any of the study insulins or their excipients. [24] Hematologic: have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c measurement. [25] Glucocorticoid therapy: receiving chronic (lasting longer than 14 consecutive d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that glycemic control as measured by HbA1c at 26 weeks for LY2605541 is non-inferior to insulin glargine when each is combined with pre-prandial insulin lispro in patients with type 1 diabetes mellitus. ;Secondary Objective: Gated: To demonstrate that LY2605541 is superior to insulin glargine (both in combination with pre-prandial insulin lispro) at 26 weeks for: 1.Nocturnal hypoglycemia rate. 2.HbA1c 3.Proportion of patients with HbA1c <7.0% 4.FSG by laboratory measurement 5.Total hypoglycemia rate. Non-gated: To compare the efficacy and safety of LY2605541 versus insulin glargine (both in combination with pre-prandial insulin lispro) treatment groups for: 1.Total and nocturnal hypoglycemia rates and incidences 2.Weight change from baseline 3.SMBG 9-point profiles 4.Proportion of patients with HbA1c <7.0% and =6.5% 5.Proportion of patients with HbA1c <7.0% without nocturnal hypoglycemia 7.HbA1c change from baseline 8.HbA1c at 52 and 78 weeks 9.Basal, mealtime, and total insulin dose (units and units/kg) 10.Triglycerides (log transformation prior to analysis), total cholesterol, LDL-cholesterol, HDL-cholesterol ;Primary end point(s): A change of HbA1c from baseline to 26 weeks that is not inferior to glargine when each is combined with pre-prandial insulin lispro.;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Nocturnal hypoglycemia rate; HbA1c; proportion of patients with HbA1c <7.0%; FSG (laboratory measurement); total hypoglycemia rate; total and nocturnal hypoglycemia rates and incidences; weight change from baseline, SMBG 9-point profiles; proportion of patients with HbA1c <7.0%; proportion of patients with HbA1c = 6.5%, proportion of patients with HbA1c < 7.0% without nocturnal hypoglycemia; HbA1c change from baseline; HbA1c at 52 and 78 weeks; basal, bolus, and total insulin doses (units and units/kg); triglycerides (log transformation prior to analysis), total cholesterol, LDL-C, HDL-C; antibodies to LY2605541; FSG by laboratory; FBG (as measured by SMBG), FBG intra-patient variability (as measured by SMBG); 0300-hour BG to fasting BG excursion; ITSQ; LBSS; EQ-5D; RAPA; additional safety endpoints (treatment-emergent adverse events [TEAEs], SAEs, vital signs, treatment exposure, other laboratory measures, etc.);Timepoint(s) of evaluation of this end point: All gated objective endpoints are at 26 weeks of treatment. Nocturnal and total hypoglycemia rates and incidences have various timepoints such as 0 to 2 weeks, 0 to 12 weeks, 0 to 26 weeks, 0 to 52 weeks, 0 to 78 weeks, 2 to 12 weeks, 2 to 26 weeks, 12 to 26 weeks, 12 to 52 weeks, 12 to 78 weeks, 26 to 52 weeks, 52 to 78 weeks; at 52 and 78 weeks for proportion of patients with HbA1c <7.0%, HbA1c and FSG by laboratory; at 26 weeks for ITSQ and EQ-5D, at 26 and 78 weeks for RAPA, and at 26, 52 and 78 weeks for all the other objectives. | — |
Countries
Austria, France, Germany, Italy, Japan, Mexico, Poland, Russian Federation, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed