A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes (IMAGINE 6)

Lilly

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2605541; Drug: Oral Antihyperglycemic Medications (OAM); Drug: Human Insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT01790438

12143

I2R-MC-BIAK (Other Identifier)

2012-003941-13 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 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 night time blood sugar episodes
• The total number of low blood sugar episodes reported

Enrollment: 641 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have had type 2 diabetes mellitus for at least 1 year, not treated with insulin
• Have been receiving 2 or more OAMs for at least 3 months prior to the study
• Have a hemoglobin A1c (HbA1c) of 7.0% to 11.0%, inclusive, 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 are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, 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 used insulin therapy in the past 2 years (except for use during pregnancy or for short term use for acute conditions)
• Have been treated with glucagon-like peptide-1 (GLP-1) receptor agonist, rosiglitazone, pramlintide, or weight-loss medication within 3 months before 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 before screening, prescription or over-the-counter medications to promote weight loss
• Have had any episodes of severe hypoglycemia, diabetic ketoacidosis, or hyperosmolar state/coma within 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 millimoles per liter (mmol/L)]
• Have obvious clinical signs or symptoms of liver disease [excluding nonalcoholic fatty liver disease (NAFLD)], acute or chronic hepatitis, nonalcoholic 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 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
• Are using or have used any of the following lipid-lowering medications: niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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641 participants in 2 patient groups

LY2605541

Experimental group

Description:

Administered by subcutaneous (SC) injection once daily in the morning or at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on Fasting Blood Glucose (FBG). LY2605541 will be given alone or in combination with up to 3 pre-study oral antihyperglycemic medications [OAM(s)] whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks.

Treatment:

Drug: Oral Antihyperglycemic Medications (OAM)

Drug: LY2605541

Human Insulin NPH

Active Comparator group

Description:

Administered by SC injection once daily at bedtime. Initial dose is 10 units (or less for some of the participants in Korea) and is adjusted weekly based on FBG. Human insulin NPH will be used alone or in combination with up to 3 pre-study OAM(s) whose use is not excluded in combination with insulin. Treatment may last up to 26 weeks. Some participants who are unable to achieve glycemic control after at least 12 weeks of treatment with a single injection of NPH may be asked to add a second injection prior to the morning meal.

Treatment:

Drug: Human Insulin NPH

Drug: Oral Antihyperglycemic Medications (OAM)