A Study for Patients With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: LY2605541; Drug: insulin glargine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01027871

12149

I2R-MC-BIAC (Other Identifier)

Details and patient eligibility

About

Comparison of fasting blood glucose levels in patients with Type 2 diabetes after 12 weeks of treatment with a new basal insulin analog or with insulin glargine.

Full description

Patients in this study will continue to use their stable prestudy dose of metformin and/or a sulfonylurea. Prestudy therapy also includes once daily insulin glargine or neutral protamine Hagedorn (NPH) insulin. The 12-week active treatment phase will be followed by a 4-week follow-up period, during which patients will return to the basal insulin recommended by the investigator.

Enrollment: 289 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes mellitus (T2DM) for at least 1 year
• At least 18 years of age
• Using metformin and/or sulfonylurea(s) with once daily glargine or NPH for at least 3 months prior to the study. Prestudy dose requirements: insulin dose maximum 1.0 unit/kilogram/day (U/kg/day). Oral antihyperglycemic medications (OAMs): Metformin dose at least 1500 milligram/day (mg/day) and/or sulfonylurea dose at least half the maximum daily dose specified in the local package insert. OAM doses stable for 6 weeks prior to the study.
• Hemoglobin A1c (HbA1c) less than or equal to 10.5% before randomization
• Body Mass Index (BMI) 19 to 45 kilogram/square meter (kg/m²)
• Capable and willing to prepare and inject insulin with a syringe while continuing to use the prestudy OAMs, monitor own blood glucose; complete the study diary; be receptive to diabetes education; comply with study visits and receive telephone calls between visits
• Women of childbearing potential must test negative for pregnancy before receiving treatment and agree to use reliable birth control until completing the follow-up visit

Exclusion criteria

• Long-term use of short- or rapid-acting or premixed insulin within the 6 months before the study. Short-term insulin therapy or occasional use are permitted
• Use of any glucose-lowering medications not allowed by the inclusion criteria in the 3 months before entry into the study
• Use of prescription or over-the-counter medications to promote weight loss within 3 months before entry into the study
• Current participation in a weight loss program, or plans to do so during the study
• Treatment with any antibody-based therapy within 6 months prior to the study
• Use of chronic (>14 consecutive days) systemic glucocorticoid therapy currently or within 4 weeks prior to the study
• More than 1 episode of severe hypoglycemia within 6 months prior to the study, or currently diagnosed with hypoglycemia unawareness
• 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months preceding the study
• Liver disease
• History of renal transplantation, current renal dialysis, or creatinine >2.0 milligram/deciliter (mg/dL) (177 micromole/Liter [μmol]/L)
• Cardiac disease with a marked impact on physical functioning
• Clinically significant electrocardiogram (ECG) abnormalities at screening
• Malignancy other than basal cell or squamous cell skin cancer
• Fasting triglycerides >500 mg/dL
• Known diabetic autonomic neuropathy
• Known hypersensitivity or allergy to study insulin or its excipients
• Blood transfusion or severe blood loss within 3 months prior to entry into the study or known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the HbA1c methodology
• Irregular sleep/wake cycle
• Women who are breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 3 patient groups

LY2605541 Dosing Algorithm 1

Experimental group

Description:

Participants took both LY2605541 and their pre-study insulin for first several days

Treatment:

Drug: LY2605541

LY2605541 Dosing Algorithm 2

Experimental group

Description:

Participants took only LY2605541 with first dose doubled

Treatment:

Drug: LY2605541

Insulin glargine

Active Comparator group

Treatment:

Drug: insulin glargine