Intervention: Basaglar
Trial phase: Phase 3
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Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 159
Group description: Insulin glargine was administered by SQ injection once daily at bedtime for up to 52 weeks. Initial dose based on dose of prestudy basal insulin and adjusted based on FBG.
Eligibility criteria:
Inclusion Criteria:

Have had type 2 diabetes mellitus for at least 1 year
Have been receiving basal insulin (neutral protamine Hagedorn [NPH], detemir, or glargine) and a stable dose of 0 to 3 oral antihyperglycemic medications (OAMs) used as specified in the local prescribing information for at least 90 days prior to screening. At least 1 of the OAMs must be dosed at, or above, half the maximum daily dose allowed by local regulations or at the maximally tolerated dose
Have a hemoglobin A1c (HbA1c) less than or equal to 9.0% at screening
Have a body mass index (BMI) less than or equal to 45.0 kilograms per square meter (kg/m^2)
Women of childbearing potential who are not breastfeeding, have a negative pregnancy test at screening and randomization, do not plan to become pregnant during the study, and have practiced reliable birth control for at least 6 weeks prior to screening and will continue to do so during the study and until 2 weeks after the last dose of study drug

Exclusion Criteria:

Have routinely used insulin glargine twice daily in the 90 days prior to the study or have used routine, mealtime insulin therapy (outside of pregnancy) anytime in the past 6 months, except for short-term treatment up to a maximum of 4 continuous weeks
Have used rosiglitazone, pramlintide, glucagon-like peptide 1 (GLP-1) receptor agonist concurrently or within 90 days prior to screening
For participants on OAMs: have any restrictions for cardiac, renal, and hepatic diseases in the local product regulations
Are taking, or have taken within the 90 days preceding screening, prescription or over-the-counter 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 diabetic ketoacidosis or hyperosmolar state/coma in the 6 months prior to screening
Have cardiac disease with functional status that is New York Heart Association Class III or IV
Have a history of renal transplantation, or are currently receiving renal dialysis or have serum creatinine greater than or equal to 2 milligrams per deciliter (mg/dL) (177 micromoles per liter [µmol/L])
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
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 cancer, have been in remission from clinically significant cancer(other than basal cell or squamous cell skin cancer) for less than 5 years, or are at increased risk for developing cancer or a recurrence of cancer in the opinion of the investigator
Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intranasal, intraocular, and inhaled preparations) or have received such therapy within the 8 weeks immediately preceding screening
Have fasting triglycerides greater than 400 mg/dL (4.5 millimoles per liter [mmol/L]) at screening
Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night) in the investigator's opinion

Lipid-lowering medication: Are using or have used any of the following:

niacin preparations as a lipid-lowering medication and/or bile acid sequestrants within 90 days prior to screening or
lipid-lowering medication at a dose that has not been stable for at least 90 days prior to screening