Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, International Randomized, 2x2 Factorial Design Study to Evaluate the Effects of Lantus (Insulin Glargine) Versus Standard Care, and of Omega-3 Fatty Acids Versus Placebo, in Reducing Cardiovascular Morbidity and Mortality in High Risk People With Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or Early Type 2 Diabetes Mellitus: The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Brief Summary: The primary objectives of the ORIGIN study were:

* To determine whether insulin glargine-mediated normoglycemia can reduce cardiovascular morbidity and/or mortality in people at high risk for vascular disease with either Impaired Fasting Glucose (IFG), Impaired Glucose Tolerance (IGT) or early type 2 diabetes;
* To determine whether omega-3 fatty acids can reduce cardiovascular mortality in people with IFG, IGT or early type 2 diabetes.

The secondary objectives of the insulin glargine study were to determine if insulin glargine-mediated normoglycemia can reduce:

* total mortality (all causes);
* the risk of diabetic microvascular outcomes;
* the rate of progression of IGT or IFG to type 2 diabetes.


Options:
A: Arm Label: Exercise under observation; Type: EXPERIMENTAL; Interventions: Behavioral: Modified paleolithic diet and exercise under observation | Arm Label: General advice on exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Modified paleolithic diet and general advice on exercise | Intervention Type: BEHAVIORAL; Name: Modified paleolithic diet and exercise under observation; Assigned to Arm(s): Exercise under observation | Intervention Type: BEHAVIORAL; Name: Modified paleolithic diet and general advice on exercise; Assigned to Arm(s): General advice on exercise
B: Intervention Type: DRUG; Name: hormone replacement therapy; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogens; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: progestins; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: estrogen replacement therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: diet, fat-restricted; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: calcium; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: vitamin D; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: dietary supplements; Assigned to Arm(s): N/A
C: Intervention Type: BEHAVIORAL; Name: dietary intervention; Assigned to Arm(s): N/A
D: 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

Answer: D