Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2, Open-Label, Multi-Center Study Evaluating the Efficacy, Safety and Pharmacokinetics of Genz-112638 in Gaucher Type 1 Patients
Brief Summary: Gaucher disease is a genetic disease that results in a deficiency of an enzyme acid beta-glucosidase, also known as glucocerebrosidase. This enzyme is needed to digest a substrate (lipid) called glucosylceramide and, to a lesser degree, glucosylsphingosine. In participants with Gaucher disease, the liver, spleen, bone marrow and brain show increases in lipid concentration, specifically in cells derived from the monocyte/macrophage system.

Eliglustat tartrate (Genz-112638) is an oral drug that may regulate the Gaucher disease process by decreasing the synthesis of glucosylceramide. The primary objective of this study is to evaluate the efficacy, safety and pharmacokinetics (PK) of eliglustat tartrate, administered as an oral dose of either 50 milligram (mg) twice daily (BID) or 100 mg BID, to men and women with Gaucher disease Type 1 for 52 weeks.


Options:
A: 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
B: Arm Label: Eliglustat tartrate; Type: EXPERIMENTAL; Interventions: Drug: Eliglustat tartrate | Intervention Type: DRUG; Name: Eliglustat tartrate; Assigned to Arm(s): Eliglustat tartrate
C: Arm Label: Active; Type: EXPERIMENTAL; Interventions: Drug: Eliglustat tartrate | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Eliglustat tartrate; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: prGCD 30 Units/kg; Type: EXPERIMENTAL; Interventions: Drug: Plant cell expressed recombinant glucocerebrosidase (prGCD) | Arm Label: prGCD 60 Units/kg; Type: EXPERIMENTAL; Interventions: Drug: Plant cell expressed recombinant glucocerebrosidase (prGCD) | Intervention Type: DRUG; Name: Plant cell expressed recombinant glucocerebrosidase (prGCD); Assigned to Arm(s): prGCD 30 Units/kg | Intervention Type: DRUG; Name: Plant cell expressed recombinant glucocerebrosidase (prGCD); Assigned to Arm(s): prGCD 60 Units/kg

Answer: B