Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Twenty-six Week, Randomized, Open-label, 2-Arm Parallel Group Real World Pragmatic Trial to Assess the Clinical and Health Outcomes Benefit of Toujeo® Compared to "Standard of Care" Insulin for Initiating Basal Insulin in Insulin Naïve Patients With Uncontrolled Type 2 Diabetes Mellitus, With 6-Month Extension
Brief Summary: Primary Objective:

To demonstrate noninferiority of Toujeo versus "standard of care" basal insulin therapy measured as glycosylated hemoglobin (HbA1c) change

Secondary Objectives:

* To demonstrate superiority of Toujeo versus "standard of care" basal insulin if noninferiority is met, measured as HbA1c change.
* To compare Toujeo to other "standard of care" basal insulin in terms of patient persistence with assigned basal insulin therapy with or without intensification.
* Risk of hypoglycemia including the incidence of documented symptomatic or severe hypoglycemic events \[as defined by the American Diabetes Association (ADA\] Workgroup on Hypoglycemia).
* Change in fasting plasma glucose (FPG).
* Change in body weight.
* Differences in patient reported outcomes measured by Diabetes Treatment Satisfaction Questionnaire Status and Change Versions (DTSQs and DTSQc).
* Change in hypoglycemic control subscale (HCS)
* Healthcare resource utilization including hospitalizations and emergency department or other health care provider visits and healthcare costs.


Options:
A: Intervention Type: DRUG; Name: Insulin glargine; Assigned to Arm(s): N/A
B: Arm Label: Toujeo; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (U300) | Arm Label: "Standard of care" commercially available basal insulin; Type: ACTIVE_COMPARATOR; Interventions: Drug: insulin glargine (U100), Drug: NPH insulin, Drug: insulin detemir, Drug: insulin degludec | Intervention Type: DRUG; Name: insulin glargine (U300); Assigned to Arm(s): Toujeo | Intervention Type: DRUG; Name: insulin glargine (U100); Assigned to Arm(s): "Standard of care" commercially available basal insulin | Intervention Type: DRUG; Name: NPH insulin; Assigned to Arm(s): "Standard of care" commercially available basal insulin | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): "Standard of care" commercially available basal insulin | Intervention Type: DRUG; Name: insulin degludec; Assigned to Arm(s): "Standard of care" commercially available basal insulin
C: Arm Label: Liraglutide; Type: EXPERIMENTAL; Interventions: Drug: liraglutide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: liraglutide; Assigned to Arm(s): Liraglutide | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
D: Arm Label: Standard glycemic control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Arm Label: Intensive glycemic control; Type: EXPERIMENTAL; Interventions: Drug: Insulin, Drug: Glimepiride, Drug: Rosiglitazone, Drug: Metformin | Intervention Type: DRUG; Name: Insulin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Glimepiride; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Rosiglitazone; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Intensive glycemic control, Standard glycemic control

Answer: B