Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: CSP #465 - Glycemic Control and Complications in Diabetes Mellitus Type 2 (VADT)
Brief Summary: This study is a prospective, 2-arm, randomized controlled trial to determine whether glycemic control, achieved through intensification of treatment, is effective in preventing clinical macrovascular complications in patients with type 2 DM who are no longer responsive to oral agents alone. The study consists of a two-year accrual period and five years of follow-up (7 years total) of 1700 patients across 20 centers. We have powered the study to detect a 21% reduction in the primary event rate. Additional study goals are to determine whether the expenditures, discomfort, and adverse effects associated with intensive intervention are justified in terms of their clinical benefits, considering both macrovascular and microvascular complications.


Options:
A: Intervention Type: BEHAVIORAL; Name: Aerobic exercise; Assigned to Arm(s): N/A
B: Arm Label: Insulin glargine + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: omega-3 polyunsaturated fatty acids (PUFA), Device: reusable pen device for insulin injection | Arm Label: Insulin glargine + placebo; Type: EXPERIMENTAL; Interventions: Drug: insulin glargine (HOE901), Drug: placebo, Device: reusable pen device for insulin injection | Arm Label: Standard care + omega-3 polyunsaturated fatty acids; Type: EXPERIMENTAL; Interventions: Drug: omega-3 polyunsaturated fatty acids (PUFA) | Arm Label: Standard care + placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: insulin glargine (HOE901); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo | Intervention Type: DRUG; Name: omega-3 polyunsaturated fatty acids (PUFA); Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Standard care + omega-3 polyunsaturated fatty acids | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Insulin glargine + placebo, Standard care + placebo | Intervention Type: DEVICE; Name: reusable pen device for insulin injection; Assigned to Arm(s): Insulin glargine + omega-3 polyunsaturated fatty acids, Insulin glargine + placebo
C: Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Group Self-Management Intervention (SMI); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-Management Intervention | Arm Label: SMI + Risk Results; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Self-Management Intervention, Behavioral: Risk Result | Intervention Type: BEHAVIORAL; Name: Self-Management Intervention; Assigned to Arm(s): Group Self-Management Intervention (SMI), SMI + Risk Results | Intervention Type: BEHAVIORAL; Name: Risk Result; Assigned to Arm(s): SMI + Risk Results
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: D