Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Alirocumab Versus Usual Care in Patients With Type 2 Diabetes and Mixed Dyslipidemia at High Cardiovascular Risk With Non-HDL-C Not Adequately Controlled With Maximally Tolerated Statin Therapy
Brief Summary: Primary Objective:

To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy.

Secondary Objectives:

* To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein \[VLDL\], HDL, and intermediate-density lipoprotein \[IDL\] particle number).
* To assess changes in glycemic parameters with alirocumab vs. usual care treatment.
* To demonstrate the safety and tolerability of alirocumab.
* To evaluate treatment acceptance of alirocumab.
* To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development.
* To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).


Options:
A: Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Evolocumab; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab | Intervention Type: BIOLOGICAL; Name: Evolocumab; Assigned to Arm(s): Evolocumab | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Evolocumab; Type: EXPERIMENTAL; Interventions: Biological: Evolocumab, Drug: Atorvastatin, Drug: Ezetimibe, Other: Diet Only | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo, Drug: Atorvastatin, Drug: Ezetimibe, Other: Diet Only | Intervention Type: BIOLOGICAL; Name: Evolocumab; Assigned to Arm(s): Evolocumab | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Atorvastatin; Assigned to Arm(s): Evolocumab, Placebo | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Evolocumab, Placebo | Intervention Type: OTHER; Name: Diet Only; Assigned to Arm(s): Evolocumab, Placebo
C: Arm Label: Bococizumab (PF-04950615;RN316); Type: EXPERIMENTAL; Interventions: Drug: Bococizumab (PF-04950615;RN316) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Bococizumab (PF-04950615;RN316); Assigned to Arm(s): Bococizumab (PF-04950615;RN316) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: Alirocumab 75 mg Q2W/Up to 150 mg Q2W; Type: EXPERIMENTAL; Interventions: Drug: Alirocumab, Drug: Statins, Drug: Antihyperglycemic Drug | Arm Label: Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Statins, Drug: Ezetimibe, Drug: Fenofibrate, Drug: Nicotinic acid, Drug: Omega-3 fatty acids, Drug: Antihyperglycemic Drug | Intervention Type: DRUG; Name: Alirocumab; Assigned to Arm(s): Alirocumab 75 mg Q2W/Up to 150 mg Q2W | Intervention Type: DRUG; Name: Statins; Assigned to Arm(s): Alirocumab 75 mg Q2W/Up to 150 mg Q2W, Usual Care | Intervention Type: DRUG; Name: Ezetimibe; Assigned to Arm(s): Usual Care | Intervention Type: DRUG; Name: Fenofibrate; Assigned to Arm(s): Usual Care | Intervention Type: DRUG; Name: Nicotinic acid; Assigned to Arm(s): Usual Care | Intervention Type: DRUG; Name: Omega-3 fatty acids; Assigned to Arm(s): Usual Care | Intervention Type: DRUG; Name: Antihyperglycemic Drug; Assigned to Arm(s): Alirocumab 75 mg Q2W/Up to 150 mg Q2W, Usual Care

Answer: D