a study for patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: 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.

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.

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