The Impact of LY2605541 Versus Insulin Glargine for Patients With Type 2 Diabetes Mellitus Advanced to Multiple Injection Bolus Insulin With Insulin Lispro: a Double-Blind, Randomized, 26-week Study - The IMAGINE 4 Study
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 1,369
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
Study Overview
Brief Summary
The purpose of this study is:
- To compare blood glucose (blood sugar) control on LY2605541 with insulin glargine after 26 weeks of treatment.
- To compare the rate of night time hypoglycemia (low blood glucose) on LY2605541 with insulin glargine during 26 weeks of treatment.
- To compare the number of participants on LY2605541 reaching blood glucose targets without hypoglycemia episodes at night to those taking insulin glargine after 26 weeks of treatment.
- To compare the rate of hypoglycemia over a 24-hour period on LY2605541 with insulin glargine during 26 weeks of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Insulin Glargine + Insulin Lispro
Participant-specific dose of Insulin Glargine will be administered subcutaneously (SC) once daily at bedtime for 26 weeks.
Participant-specific dose of Insulin Lispro will be administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.
Intervention: Insulin Glargine (Drug)
Insulin Glargine + Insulin Lispro
Participant-specific dose of Insulin Glargine will be administered subcutaneously (SC) once daily at bedtime for 26 weeks.
Participant-specific dose of Insulin Lispro will be administered SC for preprandial (pre-meal) and supplemental doses for 26 weeks.
Intervention: Insulin Lispro (Drug)
LY2605541 + Insulin Lispro
Participant-specific dose of LY2605541 will be administered SC once daily at bedtime for 26 weeks.
Participant-specific dose of Insulin Lispro will be administered SC for preprandial and supplemental doses for 26 weeks.
Intervention: LY2605541 (Drug)
LY2605541 + Insulin Lispro
Participant-specific dose of LY2605541 will be administered SC once daily at bedtime for 26 weeks.
Participant-specific dose of Insulin Lispro will be administered SC for preprandial and supplemental doses for 26 weeks.
Intervention: Insulin Lispro (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks
Time Frame: Baseline, 26 weeks
HbA1c is a test that measures a participant's average blood glucose level over a 2 to 3 month timeframe. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for stratification factors (country, low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and number of insulin injections at baseline \[1, 2, or ≥3\]), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Secondary Outcomes
- Percentage of Participants With Total Hypoglycemia Episodes(Baseline through 26 weeks)
- Basal, Bolus, and Total Insulin Dose by Weight at 26 Weeks(26 weeks)
- HbA1c at 26 Weeks(26 weeks)
- Total Hypoglycemia Rates (Adjusted for 30 Days)(Baseline through 26 weeks)
- Percentage of Participants With HbA1c <7.0% and ≤6.5% at 26 Weeks(up to 26 weeks)
- Fasting Serum Glucose (FSG) From Laboratory at 26 Weeks(26 weeks)
- Fasting Blood Glucose (FBG) (by SMBG) Intra-participant Variability at 26 Weeks(26 weeks)
- Number of Participants With Change in Anti-LY2605541 Antibodies From Baseline to 26 Weeks(Baseline through 26 weeks)
- Nocturnal Hypoglycemia Rates (Adjusted for 30 Days)(Baseline through 26 weeks)
- Percentage of Participants With Nocturnal Hypoglycemia Episodes(Baseline through 26 weeks)
- Body Weight Change From Baseline to 26 Weeks(Baseline, 26 weeks)
- Self-Monitored Blood Glucose (SMBG) 9-point Profiles at 26 Weeks(26 weeks)
- Lipid Profile at 26 Weeks(26 weeks)
- EuroQoL-5D (EQ-5D) at 26 Weeks(up to 26 weeks)
- Percentage of Participants With HbA1c <7.0% Without Nocturnal Hypoglycemia at 26 Weeks(up to 26 weeks)
- 0300-hour Blood Glucose to FBG Excursion at 26 Weeks(26 weeks)
- Insulin Treatment Satisfaction Questionnaire (ITSQ) at 26 Weeks(up to 26 weeks)
- Low Blood Sugar Survey (LBSS) at 26 Weeks(26 weeks)
- Rapid Assessment of Physical Activity (RAPA) at 26 Weeks(up to 26 weeks)