NCT01582451CompletedPhase 3
A Comparison of LY2605541 Versus Insulin Glargine Alone or in Combination With Pre-study Oral Antihyperglycemic Medications in Patients With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin: An Open-Label, Randomized Study The IMAGINE 5 Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 466
- Locations
- 1
- Primary Endpoint
- Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
Study Overview
Brief Summary
The purpose of this study is to compare LY2605541 and insulin glargine using the following measures after participants have been treated for 26 weeks:
- Change in participants' overall blood sugar control
- The rate of night time low blood sugar episodes
- The number of participants that reach blood sugar targets without low blood sugar episodes at night
- The rate of low blood sugar episodes reported over a 24-hour period
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have had type 2 diabetes mellitus for at least 1 year
- •Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
- •Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
- •Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
- •Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug
Exclusion Criteria
- •Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
- •Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
- •For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
- •Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter 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 diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
- •Have cardiac disease with functional status that is New York Heart Association Class III or IV
- •Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L])
- •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
- •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 cancer, have been in remission from clinically significant cancer(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
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
- •Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L]) at screening
- •Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion
- •Lipid-lowering medication: Are using or have used any of the following:
- •niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
- •lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening
Arms & Interventions
LY2605541
Experimental
Administered by subcutaneous (SQ) injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on fasting blood glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications (OAMs) whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Intervention: LY2605541 (Drug)
Insulin glargine
Active Comparator
Administered by SQ injection once daily at bedtime. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG. Insulin glargine will be used alone or in combination with up to 3 pre-study OAMs whose use is not excluded in combination with insulin. Treatment may last up to 52 weeks.
Intervention: Insulin glargine (Drug)
Outcomes
Primary Outcomes
Change From Baseline to 26-week Endpoint in Hemoglobin A1c (HbA1c)
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, baseline low-density lipoprotein cholesterol \[LDL-C, \<100 milligrams per deciliter (mg/dL) and ≥100 mg/dL\], and sulfonylurea (SU) or meglitinide use), visit, treatment, visit-by-treatment interaction, and baseline HbA1c.
Secondary Outcomes
- Percentage of Participants With HbA1c <7.0% and Without Nocturnal Hypoglycemia(26 and 52 weeks)
- Fasting Serum Glucose (FSG) (by Laboratory)(26 and 52 weeks)
- Insulin Dose Per Kilogram of Body Weight(26 and 52 weeks)
- Change From Baseline to 52 Weeks in HbA1c(Baseline, 52 weeks)
- Rate of Total and Nocturnal Hypoglycemia Events (Adjusted by 30 Days)(Baseline through 26 weeks and Baseline through 52 weeks)
- Percentage of Participants That Have Total and Nocturnal Hypoglycemic Events(Baseline through 26 weeks and Baseline through 52 weeks)
- Percentage of Participants With HbA1c Equal to or Less Than (≤) 6.5% and Less Than (<) 7.0%(26 and 52 weeks)
- Fasting Blood Glucose (FBG) (by Self Monitoring)(26 and 52 weeks)
- Intra-participant Variability in Fasting Blood Glucose (FBG)(26 and 52 weeks)
- 6-point Self-monitored Blood Glucose (SMBG)(26 and 52 weeks)
- HbA1c(26 and 52 weeks)
- Number of Insulin Dose Adjustments to Steady-state(Baseline through 26 weeks)
- European Quality of Life - 5 Dimension (EuroQol-5D) Score(26 weeks)
- Insulin Treatment Satisfaction Questionnaire (ITSQ) Score(26 weeks)
- Adult Low Blood Sugar Survey (LBSS) Score(26 weeks)
- Change From Baseline in Body Weight(Baseline, 26 weeks, 52 weeks)
- Change From Baseline in Lipid Profile(Baseline, 26 weeks, 52 weeks)
- Number of Participants With Change in Anti-LY2605541 Antibodies(Baseline through 52 weeks)
Investigators
Study Sites (1)
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