Intervention: Basaglar
Trial phase: Phase 3
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Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 535
Group description: Glargine titrated based on blood glucose readings, administered SC, once daily in combination with at least 2 pre-study OAMs prescribed by the personal physician, for 52 weeks
Eligibility criteria:
Inclusion Criteria:

Have type 2 diabetes mellitus, not treated with insulin, for at least 1 year prior to the study
Have been receiving at least 2 OAMs for at least 3 months before entering the study
Have a hemoglobin A1c (HbA1c) value between 7.0% and 11.0%, inclusive, at screening
Are capable of and willing to inject insulin with a vial and syringe and perform self blood glucose monitoring
Women of childbearing potential only: are not breastfeeding, have a negative pregnancy test at the time of screening and randomization, intend to not become pregnant during the trial, have practiced a reliable method of birth control for at least 6 weeks prior to screening, and agree to use a reliable method of birth control during the study and until 2 weeks following the last dose of study drug

Exclusion Criteria:

Have used insulin therapy (outside of pregnancy) anytime in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 continuous weeks
Use of rosiglitazone, pramlintide, or glucagon-like peptide 1 (GLP-1) receptor agonist (for example, exenatide, exenatide once weekly, or liraglutide) concurrently or within 3 months prior to screening
Are currently taking, or have taken within the 3 months preceding screening, medications to promote weight loss
Have had any episodes of severe hypoglycemia within 6 months prior to screening
Have had 1 or more episodes of ketoacidosis or hyperosmolar state/coma in the 6 months prior to the study
Have cardiac disease with functional status that is New York Heart Association Class III or IV (per New York Heart Association [NYHA] Cardiac Disease Classification)
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater or equal than 2 milligrams per deciliter (mg/dL)
Have obvious clinical signs or symptoms of liver disease (excluding non- alcoholic fatty liver disease [NAFLD]), acute or chronic hepatitis, non-alcoholic steatohepatitis (NASH), or elevated liver enzyme measurements at screening
Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c
Have active or untreated malignancy or have been in remission from clinically significant malignancy for less than 5 years
Have fasting or non-fasting triglycerides greater than 400 mg/dL (greater than 4.5 millimoles per liter [mmol/L]) at screening
Are using lipid-lowering medication at a dose that has not been stable for 90 days prior to screening
Are using niacin preparations as a lipid lowering medication and bile acid sequestrants within 90 days prior to screening