Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: TECOS: A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Sitagliptin in Patients With Type 2 Diabetes Mellitus and Inadequate Glycemic Control
Brief Summary: This is a clinical trial designed to assess the cardiovascular outcome of long-term treatment with sitagliptin used as part of usual care compared to usual care without sitagliptin in participants with type 2 diabetes mellitus (T2DM) having a history of cardiovascular (CV) disease and a hemoglobin A1c (HbA1c) of 6.5% to 8.0%.

Primary hypothesis A is that sitagliptin, when used as part of usual care, is non-inferior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint of Major Adverse Cardiovascular Event (MACE) plus. If hypothesis A is satisfied: hypothesis B is that sitagliptin, when used as part of usual care, is superior to usual care without sitagliptin with regard to the risk of developing a confirmed event in the primary CV composite endpoint.


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: 1.5 mg Dulaglutide; Type: EXPERIMENTAL; Interventions: Drug: Dulaglutide | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Dulaglutide; Assigned to Arm(s): 1.5 mg Dulaglutide | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Intensive Lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Intensive lifestyle | Intervention Type: BEHAVIORAL; Name: Intensive lifestyle; Assigned to Arm(s): Intensive Lifestyle | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Sitagliptin; Type: EXPERIMENTAL; Interventions: Drug: Sitagliptin | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Sitagliptin; Assigned to Arm(s): Sitagliptin | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D