Type 2 Diabetes Mellitus MedDRA version: 14.1 Level: LLT Classification code 10049746 Term: Insulin-requiring type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Product Name: LY2605541
Product Code: LY2605541
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Not yet available
Current Sponsor code: LY2605541
Other descriptive n
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have had T2DM for at least 1 year not treated with insulin Are 18 years of age or older Have been receiving 2 or more OAMs for at least 3 months prior to the study Have HbA1c of 7.0% to 11.0% Have BMI =45.0% kg/m2 Are willing and able to inject insulin and perform self-monitoring blood glucose Have given written informed consent to participate in this study Are not pregnant or breastfeeding (only applies to females of child-bearing potential) 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 470 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 160
Exclusion criteria
Exclusion criteria: Have used insulin therapy in the past 2 years Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months of Visit 1. Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 6 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that LY2605541 (pooled before morning meal [AM] administration and at bedtime [PM] administration) is noninferior to human insulin NPH for change in hemoglobin A1c (HbA1c) from baseline to 26 weeks ;Secondary Objective: to demonstrate that LY2605541 (pooled before morning meal [AM] administration and at bedtime [PM] administration) is superior to human insulin NPH (26 weeks) for: 1. Nocturnal hypoglycemia rate 2. Total hypoglycemia rate 3. Proportion of patients with HbA1c <7.0% and no nocturnal hypoglycemia 4. HbA1c change from baseline 5. Proportion of patients with HbA1c <7% 6. Fasting serum glucose (FSG) by laboratory measurement ;Primary end point(s): Change in HbA1c from baseline using pooled data from LY2605541 treatment groups compared to human insulin NPH;Timepoint(s) of evaluation of this end point: Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of nocturnal hypoglycemia events (0-12 weeks, 0-26 weeks, 12-26weeks) Number of total hypoglycemia events (0-12 weeks, 0-26 weeks, 12-26weeks) Number of severe hypoglycemia events (0-12 weeks, 0-26 weeks, 12-26weeks) Proportion of patients with at least one nocturnal hypoglycemia events (0-12 weeks, 0-26 weeks, 12-26weeks) Proportion of patients with at least one total hypoglycemia events (0-12 weeks, 0-26 weeks, 12-26weeks) Proportion of patients with at least one severe hypoglycemia events (0-26 weeks) Actual measurement of HbA1c at 26 weeks Proportion of patients with HbA1c <7.0% at week 26 with no nocturnal hypoglycemia during 26 weeks of treatment Proportion of patients with HbA1c <7.0% at 26 weeks Fasting serum glucose (FSG) by laboratory at 26 weeks (change from baseline and actual measurement) Fasting blood glucose (FBG) (by SMBG) at 26 weeks (change from baseline and actual measurement) 6-point SMBG profile during 26 weeks Change from baseline in body weight at 26 weeks Within-day glucose Standard Deviation (SD) of FBG (SMBG). Between-day glucose SD of FBG (SMBG) during the last 7 days prior to the visit Basal insulin dose proportion of patients with HbA1c =6.5% at 26 weeks proportion of patients with HbA1c =6.5% with no nocturnal hypoglycemia The time (in weeks) for basal insulin dose to steady-state dose Change in lipid labs (Triglycerides, total cholesterol, LDL-C, HDL-C) at 26 weeks ;Timepoint(s) of evaluation of this end point: The timepoints for each secondary endpoint are provided in section E5.2 | — |
Countries
Argentina, Canada, Germany, Hungary, Korea, Republic of, Mexico, Poland, Spain, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed