Conditions

Outcome Measures

Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles
8-point SMBG profiles are measured at morning FBG, midday and evening pre-meal blood glucose (BG), 2-hour postprandial BG after each of the 3 main meals, bedtime BG, 0300 hours BG. Least squares (LS) mean of the FBG is from mixed-model repeated measures (MMRM) approach, which includes fixed effects of treatment (LY2605541 algorithm 1 and 2, glargine); dose conversion (pre-interim analysis \[IA\], post-IA); stratification variables (country, baseline daily basal insulin dose group, and baseline hemoglobin A1c \[HbA1c\] group); visit; visit and treatment interaction; random effect for participant.
Week 12

Change From Baseline in Fasting Blood Glucose (FBG) at Week 12 Endpoint
Baseline, Week 12
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 Endpoint
Baseline, Week 12
Percentage of Participants With HbA1c <7.0% and ≤6.5% at Week 12 Endpoint
Week 12
Percentage of Participants With HbA1c <7.0% and HbA1c ≤6.5% at Week 12 Endpoint Who Did Not Experience a Hypoglycemic Episode During Treatment
Week 12
8-Point Self-Monitored Blood Glucose (SMBG) Measures at Week 12 Endpoint
Week 12
+15 more secondary outcomes

EXPERIMENTAL

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

Drug: LY2605541

EXPERIMENTAL

Participants took only LY2605541 with first dose doubled

Drug: LY2605541

ACTIVE COMPARATOR

Drug: insulin glargine

subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks

LY2605541 Dosing Algorithm 1LY2605541 Dosing Algorithm 2

subcutaneous injection of insulin glargine every morning with dose titration based on blood glucose measures for 12 weeks

Insulin glargine

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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

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 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
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
+3 more criteria

Contact the study team to confirm eligibility.