NCT01435616
Completed
Phase 3
A Comparison of LY2605541 Versus Insulin Glargine as Basal Insulin Treatment in Combination With Oral Anti-Hyperglycemia Medications in Insulin-Naive Patients With Type 2 Diabetes Mellitus: A Double-Blind, Randomized Study
Overview
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,538
- Locations
- 1
- Primary Endpoint
- Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
Overview
Brief Summary
The purpose of this study is:
- To compare blood sugar control on LY2605541 with insulin glargine after 52 weeks of treatment.
- To compare the rate of night time low blood sugar episodes on LY2605541 with insulin glargine during 52 weeks of treatment.
- To compare the number of participants on LY2605541 reaching blood sugar targets without low blood sugar episodes at night to those taking insulin glargine after 52 weeks of treatment.
- To compare the rate of low blood sugar episodes on LY2605541 with insulin glargine after 52 weeks of treatment
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
- •Have been receiving at least 2 OAMs for at least 3 months before entering the study
- •Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
- •Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
- •Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug
Exclusion Criteria
- •Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
- •Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
- •Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
- •Have had any episodes of severe hypoglycemia within 6 months prior to screening
- •Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
- •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)
- •Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
- •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 at screening
- •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 measurement of HbA1c
- •Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years
Arms & Interventions
LY2605541
Experimental
LY2605541 titrated based on blood glucose readings, administered subcutaneously (SC), once daily in combination with at least 2 pre-study oral antihyperglycemic medications (OAMs) prescribed by the personal physician, for 52 or 78 weeks
Intervention: LY2605541 (Drug)
Glargine
Active Comparator
Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 or 78 weeks
Intervention: Glargine (Drug)
Outcomes
Primary Outcomes
Change From Baseline to 52 Week Endpoint in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, 52 weeks
HbA1C is a test that measures a person's average blood glucose level over the past 2 to 3 months. Least Squares (LS) means were calculated using a mixed model repeated measures (MMRM) with baseline HbA1c measurement, stratification factors (country, low density lipoprotein-cholesterol \[LDL-C, \< 100 milligrams per deciliter {mg/dL} and ≥ 100 mg/dL\] and sulfonylurea \[SU\]/meglitinide use), visit, treatment, and visit-by-treatment interaction as fixed effects.
Secondary Outcomes
- Rate of Total and Nocturnal Hypoglycemia Events(Baseline to 52 weeks)
- Percentage of Participants With Hemoglobin A1c Equal or Less Than 6.5% and Less Than 7.0 %(52 weeks)
- Fasting Serum Glucose (By Laboratory Measurement)(52 weeks)
- Fasting Blood Glucose (By Participant Self-monitored Blood Glucose Readings)(52 weeks)
- 6 Point Self-monitored Blood Glucose (SMBG)(52 weeks)
- Change From Baseline to 52 Weeks in Body Weight(Baseline, 52 weeks)
- Hemoglobin A1c(52 weeks)
- Insulin Dose Per Body Weight(52 weeks)
- Number of Insulin Dose Adjustments to Steady-State(Baseline to 52 weeks)
- European Quality of Life-5 Dimension (EQ-5D)(52 weeks)
- Insulin Treatment Satisfaction Questionnaire(Up to 52 weeks)
- Adult Low Blood Sugar Survey(Up to 52 weeks)
- Change From Baseline to 52 Weeks in Triglycerides, Low Density Lipoprotein Cholesterol (LDL-C), and High Density Lipoprotein Cholesterol (HDL-C)(Baseline, 52 weeks)
- Percentage of Participants With Equal or Above 2-, and 3-fold Upper Limits of Normal (ULN) for Total Bilirubin(Up to 52 weeks)
- Overall Treatment-Emergent Anti-LY2065541 Antibody Response (TEAR)(Baseline to 78 weeks)
- Intra-participant Variability of the Fasting Blood Glucose (FBG)(52 weeks)
- Percentage of Participants With Total and Nocturnal Hypoglycemic Events(Baseline to 52 weeks)
- Percentage of Participants With HbA1C Equal or Less Than 6.5% and Less Than 7.0 % and Without Nocturnal Hypoglycemia(Up to 52 weeks)
- Percentage of Participants With Equal or Above 2- and 3-fold ULN for Alanine Transaminase/Serum Glutamic Pyruvic Transaminase (ALT/SGPT) and Aspartate Transaminase/Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)(Up to 52 weeks)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 3
A Study in Participants With Type I Diabetes MellitusDiabetes Mellitus, Type 1NCT01454284Eli Lilly and Company1,114
Completed
Phase 3
A Study in Participants With Type 1 Diabetes MellitusDiabetes Mellitus, Type 1NCT01481779Eli Lilly and Company455
Completed
Phase 3
A Study in Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01468987Eli Lilly and Company1,369
Completed
Phase 3
A Study of LY2605541 in Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT01582451Eli Lilly and Company466
Withdrawn
Phase 3
A Study of Insulin Peglispro (LY2605541) in Participants With Type 2 Diabetes MellitusDiabetes Mellitus, Type 2NCT02106364Eli Lilly and Company