Type 2 Diabetes Mellitus MedDRA version: 14.0 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Have T2DM 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 =7.0% and =65 years) yes F.1.3.1 Number of subjects for this age range 331
Exclusion criteria
Exclusion criteria: [12] Insulin pump therapy: Continuous subcutaneous insulin infusion therapy prior to screening. [13] Twice daily insulin glargine: Are using twice daily insulin glargine prior to screening. [14] Excessive insulin resistance: Defined as having received a daily dose of insulin = 2.0 units/kg at the time of pre-randomization. [15] Concomitant medications: glucagon-like peptide-1 (GLP-1) receptor agonist (eg, exenatide, exenatide once weekly, or liraglutide), thiazolidinedione (rosiglitazone, pioglitazone), or pramlintide, used concurrently or within 90 days prior to screening. [16] Lipid-lowering medications: are using niacin preparations as a lipid lowering medication and 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 a 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, it is acceptable to change the lipid-lowering medication for the patient and have the patient return =90 days later to complete some of the screening procedures again. [17] Triglycerides: Have fasting hypertriglyceridemia (defined as >4.5 mmol/L, >400 mg/dL) at screening, as determined by the central laboratory. [18] Weight loss medications: Are currently taking, or have taken within the 90 days preceding screening, prescription or over-the-counter medications to promote weight loss. [19] Severe hypoglycemia history: Have had any episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia) within 6 months prior to entry into the study. [20] Glycemic control: Have had 2 or more emergency room visits or hospitalizations due to poor glucose control within the 6 months prior to screening. [21] Diabetic ketoacidosis: Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma requiring hospitalization within 6 months prior to screening. [22] Cardiovascular: Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification). [23] Renal: Are currently receiving renal dialysis or have a serum creatinine =2.0 mg/dL, except for patients taking metformin who will be required to follow local labeling restrictions regarding metformin use and serum creatinine. [24] 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 as indicated below: • total bilirubin =2X the upper limit of normal (ULN) as defined by the central laboratory, 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) >2.5X ULN as defined by the central laboratory. [25] 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 invest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate that glycemic control as measured by change in HbA1c from baseline to 26 weeks for LY2605541 is non-inferior compared with insulin glargine when each is combined with preprandial insulin lispro with or without metformin in patients with type 2 diabetes mellitus (T2DM) who have not achieved adequate glycemic control with at least 1 injection of insulin daily with or without OAMs. ;Secondary Objective: The gated secondary objectives are to demonstrate that LY2605541 is superior to insulin glargine (each in combination with preprandial insulin lispro) for: 1. Nocturnal hypoglycemia rate 2. Proportion of patients with HbA1c <7.0% and no nocturnal hypoglycemia 3. HbA1c change from baseline 4. Proportion of patients with HbA1c < 7.0% 5. Fasting serum glucose (FSG) by laboratory measurement 6. Total hypoglycemia rate The non-gated secondary objectives are to compare the efficacy and safety of LY2605541 versus insulin glargine (each in combination with preprandial insulin lispro) for: • Total and nocturnal hypoglycemia rates • Total and nocturnal hypoglycemia incidences • Proportion of patients with HbA1c =6.5% • FBG (as measured by self-monitored blood glucose [SMBG]) • FBG intra-patient variability (SMBG) as measured by standard deviation (SD) • Weight change from baseline • SMBG 9-point profiles • HbA1c • Basal, bolus, and total insulin dose (units and units/kg);Primary end point(s): A change of HbA1c from baseline that is non-inferior to insulin glargine injected once a day each in combination with preprandial insulin lispro with or without metformin ;Timepoint(s) of evaluation of this end point: 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Nocturnal hypoglycemia rate; proportion of patients with HbA1c <7.0% and no nocturnal hypoglycemia; HbA1c change from baseline; proportion of patients with HbA1c < 7.0%; fasting serum glucose (FSG) by laboratory measurement; total hypoglycemia rate. Total and nocturnal hypoglycemia rates; total and nocturnal hypoglycemia incidences; proportion of patients with HbA1c =6.5%; FBG (as measured by self-monitored blood glucose [SMBG]); FBG intra-patient variability (SMBG) as measured by standard deviation (SD); weight change from baseline; SMBG 9-point profiles; HbA1c; basal, bolus, and total insulin dose (units and units/kg). ;Timepoint(s) of evaluation of this end point: All gated objective endpoints are at 26 weeks of treatment. Total and nocturnal hypoglycemia rates and incidences have various timepoints such as 0 to 2 weeks, 0 to 12 weeks, 0 to 26 weeks, 2 to 12 weeks, 2 to 26 weeks, 12 to 26 weeks, at 26 weeks for all other objectives. | — |
Countries
Australia, Austria, Brazil, Croatia, Czech Republic, Denmark, Germany, Greece, Hungary, Israel, Italy, Japan, Lithuania, Mexico, Netherlands, Poland, Romania, Russian Federation, Slovakia, Slovenia, Spain, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed