Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess Cardiovascular Outcomes Following Treatment With Ertugliflozin (MK-8835/PF-04971729) in Subjects With Type 2 Diabetes Mellitus and Established Vascular Disease, The VERTIS CV Study
Brief Summary: An overall study of the cardiovascular outcomes following treatment with ertugliflozin in participants with type 2 diabetes mellitus (T2DM) and established vascular disease. The main objective of this study is to assess the cardiovascular safety of ertugliflozin. This trial includes 3 pre-defined glycemic sub-studies; 1. In participants receiving background insulin with or without metformin, 2. In participants receiving background sulfonylurea monotherapy, and 3. In participants receiving background metformin with sulfonylurea (all fully-enrolled).

Participants enrolled prior to Amendment 1 were in the overall study as well as a sub-study, if they met certain entry criteria. Participants enrolled following the start of Amendment 1 were only enrolled in the overall study. The sub-studies were the initial 18 weeks of the overall study period.


Options:
A: Arm Label: BI 10773 low (drug naive); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: BI 10773 high (drug naive); Type: EXPERIMENTAL; Interventions: Drug: Placebo, Drug: BI 10773 | Arm Label: Placebo (drug naive); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Sitagliptin 100mg (drug naive); Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: Sitagliptin 100mg | Arm Label: BI 10773 low (pioglitazone); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: BI 10773 high (pioglitazone); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: Placebo (pioglitazone); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: BI 10773 low (metformin); Type: EXPERIMENTAL; Interventions: Drug: Placebo, Drug: BI 10773 | Arm Label: BI 10773 high (metformin); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: Placebo (metformin); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: BI 10773 low (metformin+sulfonylurea); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: BI 10773 high (metformin+sulfonylurea); Type: EXPERIMENTAL; Interventions: Drug: BI 10773, Drug: Placebo | Arm Label: Placebo (metformin+sulfonylurea); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sitagliptin 100mg (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Sitagliptin 100mg (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (metformin) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 low (metformin+sulfonylurea) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (drug naive) | Intervention Type: DRUG; Name: Sitagliptin 100mg; Assigned to Arm(s): Sitagliptin 100mg (drug naive) | Intervention Type: DRUG; Name: BI 10773; Assigned to Arm(s): BI 10773 high (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (pioglitazone) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (drug naive) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 high (metformin) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (metformin+sulfonylurea) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): BI 10773 low (drug naive)
B: Arm Label: Ertugliflozin, 15 mg; Type: EXPERIMENTAL; Interventions: Drug: Ertugliflozin, Drug: Glycemic Rescue | Arm Label: Ertugliflozin, 5 mg; Type: EXPERIMENTAL; Interventions: Drug: Ertugliflozin, Drug: Placebo, Drug: Glycemic Rescue | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Glycemic Rescue | Intervention Type: DRUG; Name: Ertugliflozin; Assigned to Arm(s): Ertugliflozin, 15 mg, Ertugliflozin, 5 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ertugliflozin, 5 mg, Placebo | Intervention Type: DRUG; Name: Glycemic Rescue; Assigned to Arm(s): Ertugliflozin, 15 mg, Ertugliflozin, 5 mg, Placebo
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Lixisenatide; Type: EXPERIMENTAL; Interventions: Drug: Lixisenatide (AVE0010) | Intervention Type: DRUG; Name: Lixisenatide (AVE0010); Assigned to Arm(s): Lixisenatide | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: 1 Original Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: DPPOS Group Lifestyle, Behavioral: DPPOS Boost Lifestyle, Behavioral: Intensive Lifestyle Group Session | Arm Label: 2 Original Metformin; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: DPPOS Group Lifestyle, Drug: Metformin, Behavioral: Intensive Lifestyle Group Session | Arm Label: 3 Original Placebo; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: DPPOS Group Lifestyle, Behavioral: Intensive Lifestyle Group Session | Intervention Type: BEHAVIORAL; Name: DPPOS Group Lifestyle; Assigned to Arm(s): 1 Original Lifestyle, 2 Original Metformin, 3 Original Placebo | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 2 Original Metformin | Intervention Type: BEHAVIORAL; Name: DPPOS Boost Lifestyle; Assigned to Arm(s): 1 Original Lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive Lifestyle Group Session; Assigned to Arm(s): 1 Original Lifestyle, 2 Original Metformin, 3 Original Placebo

Answer: B