Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Restoring Insulin Secretion Pediatric Medication Study
Brief Summary: The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose lowering will lead to recovery of beta-cell function that will be sustained after withdrawal of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin glargine followed by metformin.

The primary clinical question RISE will address is: Are improvements in ß-cell function following 12 months of active treatment maintained for 3 months following the withdrawal of therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell function, insulin sensitivity and glucose tolerance and the response to an intervention.


Options:
A: Intervention Type: DRUG; Name: vildagliptin; Assigned to Arm(s): N/A
B: Arm Label: 3.0 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: 2.0 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: 1.5 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: 1.0 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: 0.75 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: 0.5 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: 0.25 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Placebo tablet, Drug: Metformin | Arm Label: Sitagliptin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sitagliptin, Drug: Placebo solution, Drug: Metformin | Arm Label: Placebo/Sitagliptin (Baseline Through 104 Weeks); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo solution, Drug: Placebo tablet, Drug: Metformin | Intervention Type: DRUG; Name: LY2189265; Assigned to Arm(s): 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265, 1.0 mg LY2189265, 1.5 mg LY2189265, 2.0 mg LY2189265, 3.0 mg LY2189265 | Intervention Type: DRUG; Name: Sitagliptin; Assigned to Arm(s): Sitagliptin | Intervention Type: DRUG; Name: Placebo solution; Assigned to Arm(s): Placebo/Sitagliptin (Baseline Through 104 Weeks), Sitagliptin | Intervention Type: DRUG; Name: Placebo tablet; Assigned to Arm(s): 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265, 1.0 mg LY2189265, 1.5 mg LY2189265, 2.0 mg LY2189265, 3.0 mg LY2189265, Placebo/Sitagliptin (Baseline Through 104 Weeks) | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 0.25 mg LY2189265, 0.5 mg LY2189265, 0.75 mg LY2189265, 1.0 mg LY2189265, 1.5 mg LY2189265, 2.0 mg LY2189265, 3.0 mg LY2189265, Placebo/Sitagliptin (Baseline Through 104 Weeks), Sitagliptin
C: Arm Label: Metformin alone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Glargine followed by Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin, Drug: Glargine | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Glargine followed by Metformin, Metformin alone | Intervention Type: DRUG; Name: Glargine; Assigned to Arm(s): Glargine followed by Metformin
D: Intervention Type: DRUG; Name: vildagliptin; Assigned to Arm(s): N/A

Answer: C