A Study in Patients With Type 2 Diabetes Mellitus (IMAGINE 2)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Glargine; Drug: LY2605541

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435616

12141

I2R-MC-BIAJ (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 1,538 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter [mmol/L]) at screening
• Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
• Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,538 participants in 2 patient groups

LY2605541

Experimental group

Description:

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

Treatment:

Drug: LY2605541

Glargine

Active Comparator group

Description:

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

Treatment:

Drug: Glargine