A Study for Patients With Type 2 Diabetes

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.

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