• Male or female, Age 8 - \<18 years at the time of study entry and \<18 at the time of randomization.

• Type 1 diabetic subjects diagnosed more than 3 months ago and less than 12 months ago.

• Previously diagnosed with type 1 diabetes mellitus (based on clinical judgement and supported by laboratory analysis as per local guidelines) prior to study enrollment by WHO/ADA diagnostic criteria for glucose levels (FPG = 7.0 mmol/L \[126 mg/dL\]) or plasma glucose levels 2-hours after 75-gm oral glucose load of = 11.1 mmol/L (200 mg/dL) or a casual plasma glucose \>200 mg/dL with symptoms.

• Presence of one or more of the following: antibodies to glutamic acid decarboxylase (GAD), islet cell autoantibody (ICA), protein tyrosine phosphatase-like protein antibodies (IA-2), Insulin autoantibodies (IAA), zinc transporter 8 antibodies (ZnT8).

• Ongoing daily treatment with insulin prior to the screening visit.

• HIV antibody negative, M. tuberculosis (TB) negative (QuantiFERON-TB test negative), human chorionic gonadotropin (hCG) negative.

• Normal CBC and chemistries and only Grade 1 creatinine elevations.

• Informed consent and child assent, as age-appropriate, obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Legally Acceptable Representative (LAR) of the Subject must sign and date the Informed Consent Form (according to local requirements). The child must sign and date the Child Assent Form or provide oral assent, if required according to local requirements.

• Ability and willingness to adhere to the protocol, including performing self-measured plasma glucose profiles (Subject and LAR(s) should be evaluated as a unit).