Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Bypass Angioplasty Revascularization Investigation in Type 2 Diabetes
Brief Summary: The BARI 2D trial is a multicenter study that uses a 2x2 factorial design, with 2400 patients being assigned at random to initial elective revascularization with aggressive medical therapy or aggressive medical therapy alone with equal probability, and simultaneously being assigned at random to an insulin providing or insulin sensitizing strategy of glycemic control (with a target value for HbA1c of less than 7.0% for all patients).

SPECIFIC AIMS

A. Primary Aim

The primary aim of the BARI 2D trial is to test the following two hypotheses of treatment efficacy in 2400 patients with Type 2 diabetes mellitus and documented stable CAD, in the setting of uniform glycemic control and intensive management of all other risk factors including dyslipidemia, hypertension, smoking, and obesity:

1. Coronary Revascularization Hypothesis: a strategy of initial elective revascularization of choice (surgical or catheter-based) combined with aggressive medical therapy results in lower 5-year mortality compared to a strategy of aggressive medical therapy alone;
2. Method of Glycemic Control Hypothesis: with a target HbA1c level of less than 7.0%, a strategy of hyperglycemia management directed at insulin sensitization results in lower 5-year mortality compared to a strategy of insulin provision.

B. Secondary Aims

The secondary aims of the BARI 2D trial include: a) comparing the death, myocardial infarction or stroke combined endpoint event rate between the revascularization versus medical therapy groups and between the insulin sensitization versus insulin provision groups; b) comparing rates of myocardial infarction, other ischemic events, angina and quality of life associated with each revascularization and hyperglycemia management strategy; c) evaluating the relative economic costs associated with the trial treatment strategies, d) exploring the effect of glycemic control strategy on the progression and mechanism of vasculopathy including changes in PAI-1 gene expression.


Options:
A: Arm Label: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Glyburide, Drug: Metformin | Arm Label: Saxagliptin 5 mg + Glyburide 7.5 mg (B); Type: EXPERIMENTAL; Interventions: Drug: Saxagliptin, Drug: Glyburide, Drug: Metformin | Arm Label: Placebo + Glyburide 7.5 mg (C); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo, Drug: Glyburide, Drug: Metformin | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 2.5 mg + Glyburide 7.5 mg (A) | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin 5 mg + Glyburide 7.5 mg (B) | Intervention Type: DRUG; Name: Glyburide; Assigned to Arm(s): Saxagliptin 2.5 mg + Glyburide 7.5 mg (A), Saxagliptin 5 mg + Glyburide 7.5 mg (B) | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo + Glyburide 7.5 mg (C) | Intervention Type: DRUG; Name: Glyburide; Assigned to Arm(s): Placebo + Glyburide 7.5 mg (C) | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Placebo + Glyburide 7.5 mg (C), Saxagliptin 2.5 mg + Glyburide 7.5 mg (A), Saxagliptin 5 mg + Glyburide 7.5 mg (B)
B: Arm Label: Standard Treatment Arm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diet, Behavioral: Exercise, Behavioral: Stop smoking, Drug: Glucose lowering therapy, Drug: Blood pressure lowering therapy, Drug: Lipid lowering therapy | Arm Label: Intensive Treatment Arm; Type: EXPERIMENTAL; Interventions: Behavioral: Diet, Behavioral: Exercise, Behavioral: Stop smoking, Drug: Glucose lowering therapy, Drug: Blood pressure lowering therapy, Drug: Lipid lowering therapy | Intervention Type: BEHAVIORAL; Name: Diet; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: BEHAVIORAL; Name: Stop smoking; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: DRUG; Name: Glucose lowering therapy; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: DRUG; Name: Blood pressure lowering therapy; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm | Intervention Type: DRUG; Name: Lipid lowering therapy; Assigned to Arm(s): Intensive Treatment Arm, Standard Treatment Arm
C: Arm Label: Revascularization and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Revascularization and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions, Procedure: Coronary Artery Bypass, Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Providing (IP); Type: ACTIVE_COMPARATOR; Interventions: Drug: Insulin, sulfonylurea, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Arm Label: Medical Therapy and Insulin Sensitizing (IS); Type: ACTIVE_COMPARATOR; Interventions: Drug: Biguanides, thiazolidinediones, Drug: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers | Intervention Type: PROCEDURE; Name: Angioplasty, Transluminal, Percutaneous Coronary, other catheter-based interventions; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: PROCEDURE; Name: Coronary Artery Bypass; Assigned to Arm(s): Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Biguanides, thiazolidinediones; Assigned to Arm(s): Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Sensitizing (IS) | Intervention Type: DRUG; Name: Insulin, sulfonylurea; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Revascularization and Insulin Providing (IP) | Intervention Type: DRUG; Name: ACE Inhibitors, Angiotensin Receptor Blockers, Beta Blockers, Calcium Channel Blockers; Assigned to Arm(s): Medical Therapy and Insulin Providing (IP), Medical Therapy and Insulin Sensitizing (IS), Revascularization and Insulin Providing (IP), Revascularization and Insulin Sensitizing (IS)
D: Arm Label: linagliptin 5mg; Type: EXPERIMENTAL; Interventions: Drug: Linagliptin 5mg | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): placebo | Intervention Type: DRUG; Name: Linagliptin 5mg; Assigned to Arm(s): linagliptin 5mg

Answer: C