TrialPanorama/Dataset huggingface dataset:
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Intervention Type: DRUG; Name: Multiple vs. single courses of antenatalcorticosteroids; Assigned to Arm(s): N/A
C: Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Increasing use of Antenatal Corticosteroids (ACS) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Increasing use of Antenatal Corticosteroids (ACS); Assigned to Arm(s): Intervention
D: Intervention Type: DRUG; Name: Betamethasone sodium phos (drug); Assigned to Arm(s): N/A

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Betamethasone | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): A
B: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: betamethasone | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: betamethasone; Assigned to Arm(s): A | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): B
C: Arm Label: ACS (Group 1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethason Sodium Phosphate | Arm Label: Placebo (Group 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal saline | Intervention Type: DRUG; Name: Betamethason Sodium Phosphate; Assigned to Arm(s): ACS (Group 1) | Intervention Type: DRUG; Name: Normal saline; Assigned to Arm(s): Placebo (Group 2)
D: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Increasing use of Antenatal Corticosteroids (ACS) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Increasing use of Antenatal Corticosteroids (ACS); Assigned to Arm(s): Intervention
B: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
C: Arm Label: Registry Cohort; Type: N/A; Interventions: Other: No Intervention | Intervention Type: OTHER; Name: No Intervention; Assigned to Arm(s): Registry Cohort
D: Arm Label: ACS (Group 1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethason Sodium Phosphate | Arm Label: Placebo (Group 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal saline | Intervention Type: DRUG; Name: Betamethason Sodium Phosphate; Assigned to Arm(s): ACS (Group 1) | Intervention Type: DRUG; Name: Normal saline; Assigned to Arm(s): Placebo (Group 2)

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Betamethasone | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): A
C: Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Increasing use of Antenatal Corticosteroids (ACS) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Increasing use of Antenatal Corticosteroids (ACS); Assigned to Arm(s): Intervention
D: Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: betamethasone | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: betamethasone; Assigned to Arm(s): A | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): B

Answer: A
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Increasing use of Antenatal Corticosteroids (ACS) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Increasing use of Antenatal Corticosteroids (ACS); Assigned to Arm(s): Intervention
B: Intervention Type: DRUG; Name: Caffeine citrate injection; Assigned to Arm(s): N/A
C: Arm Label: ACS (Group 1); Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethason Sodium Phosphate | Arm Label: Placebo (Group 2); Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal saline | Intervention Type: DRUG; Name: Betamethason Sodium Phosphate; Assigned to Arm(s): ACS (Group 1) | Intervention Type: DRUG; Name: Normal saline; Assigned to Arm(s): Placebo (Group 2)
D: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: Ibuprofen group; Type: N/A; Interventions: Drug: Ibuprofen (Sanofi, Istanbul, Turkey) | Arm Label: Paracetamol group; Type: N/A; Interventions: Drug: Paracetamol (GlaxoSmithKline, Istanbul, Turkey) | Intervention Type: DRUG; Name: Ibuprofen (Sanofi, Istanbul, Turkey); Assigned to Arm(s): Ibuprofen group | Intervention Type: DRUG; Name: Paracetamol (GlaxoSmithKline, Istanbul, Turkey); Assigned to Arm(s): Paracetamol group
B: Arm Label: Paracetamol effect on ductus; Type: EXPERIMENTAL; Interventions: Drug: paracetamol, Drug: 0.45 % saline solution | Arm Label: Paracetamol effect on pain; Type: EXPERIMENTAL; Interventions: Drug: paracetamol, Drug: 0.45 % saline solution | Intervention Type: DRUG; Name: paracetamol; Assigned to Arm(s): Paracetamol effect on ductus, Paracetamol effect on pain | Intervention Type: DRUG; Name: 0.45 % saline solution; Assigned to Arm(s): Paracetamol effect on ductus, Paracetamol effect on pain
C: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
D: Arm Label: fentanyl; Type: ACTIVE_COMPARATOR; Interventions: Drug: Fentanyl | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: 5% glucose solution | Intervention Type: DRUG; Name: Fentanyl; Assigned to Arm(s): fentanyl | Intervention Type: DRUG; Name: 5% glucose solution; Assigned to Arm(s): placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Antenatal Late Preterm Steroids (ALPS): A Randomized Placebo-Controlled Trial
Brief Summary: This is a randomized placebo controlled trial to evaluate whether antenatal corticosteroids can decrease the rate of neonatal respiratory support, thus decreasing the rate of NICU admissions and improving short-term outcomes in the late preterm infant. The use of antenatal corticosteroids has been shown to be beneficial in women at risk for preterm delivery prior to 34 weeks but has not been evaluated in those likely to deliver in the late preterm period


Options:
A: Arm Label: PS Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: PS Group | Arm Label: NCPAP Group; Type: EXPERIMENTAL; Interventions: Device: NCPAP Group | Arm Label: ISX Group; Type: EXPERIMENTAL; Interventions: Drug: ISX Group | Intervention Type: DRUG; Name: PS Group; Assigned to Arm(s): PS Group | Intervention Type: DEVICE; Name: NCPAP Group; Assigned to Arm(s): NCPAP Group | Intervention Type: DRUG; Name: ISX Group; Assigned to Arm(s): ISX Group
B: Arm Label: Surfactant and Low Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: Surfactant and High Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 91 to 95% | Arm Label: CPAP and Low Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: CPAP and High Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 91 to 95% | Intervention Type: DRUG; Name: Surfactant; Assigned to Arm(s): Surfactant and High Oxygen, Surfactant and Low Oxygen | Intervention Type: DEVICE; Name: Continuous Positive Airway Pressure (CPAP); Assigned to Arm(s): CPAP and High Oxygen, CPAP and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 85 to 89%; Assigned to Arm(s): CPAP and Low Oxygen, Surfactant and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 91 to 95%; Assigned to Arm(s): CPAP and High Oxygen, Surfactant and High Oxygen
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Very early surfactant and bubble NCPAP | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: bubble NCPAP | Intervention Type: OTHER; Name: Very early surfactant and bubble NCPAP; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: bubble NCPAP; Assigned to Arm(s): 2
D: Arm Label: Betamethasone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Betamethasone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Betamethasone; Assigned to Arm(s): Betamethasone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Practice-Based Nutrition Intervention
Brief Summary: This study aims to test a dietary intervention for diabetes in a medical practice setting, with the aim of developing a model for diabetes care that can be used widely. The investigators hypothesize that a low-fat vegan diet will be effective for management of diabetes and will be feasible in a practice-based setting.


Options:
A: Arm Label: Lifestyle Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle Intervention | Arm Label: Diabetes Support and Education; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Diabetes Support and Education | Intervention Type: BEHAVIORAL; Name: Lifestyle Intervention; Assigned to Arm(s): Lifestyle Intervention | Intervention Type: BEHAVIORAL; Name: Diabetes Support and Education; Assigned to Arm(s): Diabetes Support and Education
B: Arm Label: diet following American Diabetes Association guidelines; Type: ACTIVE_COMPARATOR; Interventions: Other: diet following ADA guidelines | Arm Label: vegan diet; Type: EXPERIMENTAL; Interventions: Other: vegan diet | Intervention Type: OTHER; Name: vegan diet; Assigned to Arm(s): vegan diet | Intervention Type: OTHER; Name: diet following ADA guidelines; Assigned to Arm(s): diet following American Diabetes Association guidelines
C: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Low-fat, low-Glycemic Index, vegan diet | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Low-fat, low-Glycemic Index, vegan diet | Intervention Type: BEHAVIORAL; Name: Low-fat, low-Glycemic Index, vegan diet; Assigned to Arm(s): 1, 2
D: Arm Label: Eco-Atkins diet; Type: EXPERIMENTAL; Interventions: Other: Eco-Atkins diet (high vegetable protein and vegetable fat) | Arm Label: NCEP diet; Type: ACTIVE_COMPARATOR; Interventions: Other: NCEP diet | Intervention Type: OTHER; Name: Eco-Atkins diet (high vegetable protein and vegetable fat); Assigned to Arm(s): Eco-Atkins diet | Intervention Type: OTHER; Name: NCEP diet; Assigned to Arm(s): NCEP diet

Answer: B
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multi-center, Double-blind, Randomized, Active Reference, Parallel Group Study to Evaluate the Efficacy, Safety and Tolerability of a 10-day Twice Daily Oral Administration of Three Doses of Cadazolid (ACT-179811) in Subjects With Clostridium Difficile Associated Diarrhea (CDAD)
Brief Summary: Cadazolid is a new antibiotic developed for the treatment of Clostridiun difficile associated diarrhea (CDAD), also known as Clostridium Difficile Infection (CDI). The purpose of the study was to evaluate the efficacy and safety of different doses of cadazolid in order to find the dose of cadazolid to be used for further clinical development of the compound in subjects with CDAD.


Options:
A: Arm Label: CB-183,315, 125 mg; Type: EXPERIMENTAL; Interventions: Drug: CB-183,315, Drug: Placebo | Arm Label: CB-183,315, 250 mg; Type: EXPERIMENTAL; Interventions: Drug: CB-183,315, Drug: Placebo | Arm Label: Vancomycin, 125 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vancomycin | Intervention Type: DRUG; Name: CB-183,315; Assigned to Arm(s): CB-183,315, 125 mg, CB-183,315, 250 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): CB-183,315, 125 mg, CB-183,315, 250 mg | Intervention Type: DRUG; Name: Vancomycin; Assigned to Arm(s): Vancomycin, 125 mg
B: Arm Label: Fresh FMT; Type: EXPERIMENTAL; Interventions: Biological: Fresh FMT | Arm Label: Frozen-and-Thawed FMT; Type: EXPERIMENTAL; Interventions: Biological: Frozen-and-Thawed FMT | Intervention Type: BIOLOGICAL; Name: Fresh FMT; Assigned to Arm(s): Fresh FMT | Intervention Type: BIOLOGICAL; Name: Frozen-and-Thawed FMT; Assigned to Arm(s): Frozen-and-Thawed FMT
C: Arm Label: Cadazolid 250 mg; Type: EXPERIMENTAL; Interventions: Drug: Cadazolid, Drug: Placebo-matching vancomycin | Arm Label: Cadazolid 500 mg; Type: EXPERIMENTAL; Interventions: Drug: Cadazolid, Drug: Placebo-matching vancomycin | Arm Label: Cadazolid 1000 mg; Type: EXPERIMENTAL; Interventions: Drug: Cadazolid, Drug: Placebo-matching vancomycin | Arm Label: Vancomycin 125 mg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vancomycin, Drug: Placebo-matching cadazolid | Intervention Type: DRUG; Name: Cadazolid; Assigned to Arm(s): Cadazolid 1000 mg, Cadazolid 250 mg, Cadazolid 500 mg | Intervention Type: DRUG; Name: Vancomycin; Assigned to Arm(s): Vancomycin 125 mg | Intervention Type: DRUG; Name: Placebo-matching cadazolid; Assigned to Arm(s): Vancomycin 125 mg | Intervention Type: DRUG; Name: Placebo-matching vancomycin; Assigned to Arm(s): Cadazolid 1000 mg, Cadazolid 250 mg, Cadazolid 500 mg
D: Arm Label: GS-CDA1/MDX-1388; Type: EXPERIMENTAL; Interventions: Biological: GS-CDA1/MDX-1388 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Biological: normal saline | Intervention Type: BIOLOGICAL; Name: GS-CDA1/MDX-1388; Assigned to Arm(s): GS-CDA1/MDX-1388 | Intervention Type: BIOLOGICAL; Name: normal saline; Assigned to Arm(s): Placebo

Answer: C
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Open-label, Randomized, Multi-center, Phase III Study to Compare the Safety and Efficacy of Dovitinib Versus Sorafenib in Patients With Metastatic Renal Cell Carcinoma After Failure of Anti-angiogenic (VEGF-targeted and mTOR Inhibitor) Therapies
Brief Summary: This study will evaluate the safety and efficacy of Dovitinib versus sorafenib in patients with metastatic renal cell cancer.


Options:
A: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Temsirolimus, Drug: Bevacizumab | Arm Label: B; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sunitinib | Arm Label: C; Type: ACTIVE_COMPARATOR; Interventions: Drug: Bevacizumab, Drug: Interferon alpha-2a | Intervention Type: DRUG; Name: Temsirolimus; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Bevacizumab; Assigned to Arm(s): A, C | Intervention Type: DRUG; Name: Sunitinib; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Interferon alpha-2a; Assigned to Arm(s): C
B: Arm Label: RAD001 +BSC; Type: EXPERIMENTAL; Interventions: Drug: RAD001 | Arm Label: Placebo (plus BSC); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: RAD001; Assigned to Arm(s): RAD001 +BSC | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo (plus BSC)
C: Arm Label: Sunitinib; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sunitinib | Arm Label: Pazopanib; Type: EXPERIMENTAL; Interventions: Drug: Pazopanib | Intervention Type: DRUG; Name: Pazopanib; Assigned to Arm(s): Pazopanib | Intervention Type: DRUG; Name: Sunitinib; Assigned to Arm(s): Sunitinib
D: Arm Label: Dovitinib + best supportive care (BSC); Type: EXPERIMENTAL; Interventions: Drug: Dovitinib | Arm Label: Sorafenib + BSC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sorafenib | Intervention Type: DRUG; Name: Dovitinib; Assigned to Arm(s): Dovitinib + best supportive care (BSC) | Intervention Type: DRUG; Name: Sorafenib; Assigned to Arm(s): Sorafenib + BSC

Answer: D
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diabetes Mellitus Aged at Least 6 Years to Less Than 18 Years
Brief Summary: Primary Objective:

6 To assess the efficacy of insulin glargine given once daily (QD) on glycosylated hemoglobin (HbA1c) levels over a period of 24 weeks in children with type 1 diabetes mellitus (T1DM) aged at least 6 years to less than 18 years.

Secondary Objectives:

* To assess the effects of insulin glargine compared to NPH insulin over 24 weeks on:

  * Percentage of patients reaching International Society of Pediatric and Adolescent Diabetes (ISPAD) recommended target of HbA1c \< 7.5%,
  * Fasting blood glucose (FBG),
  * Nocturnal blood glucose (BG),
  * 24-hour blood glucose profile based on 8-point self-monitoring of blood glucose (SMBG) values,
  * Daily total insulin dose and basal insulin dose,
  * Rates of asymptomatic and/or symptomatic, severe, nocturnal and nocturnal symptomatic hypoglycemia.
* To assess the safety and tolerability of insulin glargine versus NPH insulin based on the occurrence of treatment-emergent adverse events (TEAEs).
* To assess anti-insulin and anti-glargine antibody development in both groups.
* To assess insulin glargine pharmacokinetic(PK) for all patients treated with insulin glargine in selected sites with approximately 45% of insulin glargine population to rule out accumulation tendency of insulin glargine after repeated dosing


Options:
A: Arm Label: insulin detemir; Type: EXPERIMENTAL; Interventions: Drug: insulin detemir, Drug: insulin aspart | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): insulin detemir | Intervention Type: DRUG; Name: insulin aspart; Assigned to Arm(s): insulin detemir
B: Intervention Type: BEHAVIORAL; Name: Insulin; Assigned to Arm(s): N/A
C: Arm Label: IDegAsp OD; Type: EXPERIMENTAL; Interventions: Drug: insulin degludec/insulin aspart, Drug: insulin aspart | Arm Label: IDet; Type: ACTIVE_COMPARATOR; Interventions: Drug: insulin detemir, Drug: insulin aspart | Intervention Type: DRUG; Name: insulin degludec/insulin aspart; Assigned to Arm(s): IDegAsp OD | Intervention Type: DRUG; Name: insulin detemir; Assigned to Arm(s): IDet | Intervention Type: DRUG; Name: insulin aspart; Assigned to Arm(s): IDegAsp OD | Intervention Type: DRUG; Name: insulin aspart; Assigned to Arm(s): IDet
D: Arm Label: Insulin glargine; Type: EXPERIMENTAL; Interventions: Drug: Insulin glargine (HOE901) | Arm Label: NPH insulin; Type: ACTIVE_COMPARATOR; Interventions: Drug: NPH insulin | Intervention Type: DRUG; Name: Insulin glargine (HOE901); Assigned to Arm(s): Insulin glargine | Intervention Type: DRUG; Name: NPH insulin; Assigned to Arm(s): NPH insulin

Answer: D