Intervention: CID 168324442
Trial phase: Phase 2
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Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 98
Group description: subcutaneous injection of LY2605541 every morning with dose titration based on blood glucose measures for 12 weeks
Eligibility criteria:
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