Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus

Completed · Phase 3

Conditions studied: Type 1 Diabetes Mellitus

In brief

Primary Objective: To compare the efficacy of a new formulation of insulin glargine (HOE901-U300) to Lantus in terms of change of HbA1c from baseline to endpoint (month 6) in children and adolescents with type 1 diabetes mellitus. . Secondary Objectives: To compare HOE901-U300 and Lantus in terms of: * Percentage of participants reaching target HbA1c and fasting plasma glucose (FPG). * To assess the safety of HOE901-U300 including analysis of events of hypoglycemia, events of hyperglycemia with ketosis, and development of anti-insulin-antibodies.

Key facts

Study ID

NCT02735044

Run by

Sanofi

People needed

463

Starts

2016-04-14

Expected to finish

2018-12-20

Last updated by the study team

2022-03-25

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adolescents with type 1 diabetes mellitus (T1DM) for at least 1 year confirmed by typical symptoms at diagnosis and/or by antibody testing [presence of anti-GAD (glutamic acid decarboxylase) or anti-IA2 (islet antigen 2/tyrosine phosphatase) or anti-islet cell antibodies] and/or clinical features (eg, history of ketoacidosis)].
• Signed written informed consent obtained from parent(s)/legal guardian and written or oral assent obtained from participant.

You may not qualify if…

• Age <6 years and >=18 years at randomization.
• Less than 1 year on insulin treatment prior to screening visit.
• Less than 6 months on basal plus mealtime insulin and self-monitoring of blood glucose prior to screening visit.
• Participants using premix insulins in the last 3 months before screening visit or participants using human regular insulin as mealtime insulin in the last 3 months before screening visit.
• Use of an insulin pump in the last 6 months before screening visit or plans to switch to pump within the next 6 months after screening visit.
• Any contraindication to use of insulin glargine as defined in the national product label.
• No willingness to inject insulin glargine (Lantus or HOE901-U300) once daily.
• HbA1c <7.5% or >11% at screening.
• Initiation of any glucose-lowering medications in the last 3 months before screening visit.
• Hospitalization or care in the emergency ward for diabetic ketoacidosis or history of severe hypoglycemia (as defined by need for glucagon or IV glucose) and accompanied by seizure and/or unconsciousness and/or coma in the last 3 months prior to screening visit.
• Postmenarchal girls not protected by highly-effective method(s) of birth control and/or who were unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse was considered as an acceptable form of birth control.
• Pregnant or breast-feeding adolescents, or adolescents who intended to become pregnant during the study period, or who were at risk of getting pregnant due to any psychosocial reason during the study period.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 8400037 — Atlanta, Georgia, United States
• Investigational Site Number 8400032 — Indianapolis, Indiana, United States
• Investigational Site Number 8400015 — Buffalo, New York, United States
• Investigational Site Number 8400016 — Chapel Hill, North Carolina, United States
• Investigational Site Number 8400035 — Morehead City, North Carolina, United States
• Investigational Site Number 8400038 — Oklahoma City, Oklahoma, United States
• Investigational Site Number 8400030 — Philadelphia, Pennsylvania, United States
• Investigational Site Number 8400010 — Rapid City, South Dakota, United States
• Investigational Site Number 8400005 — Dallas, Texas, United States
• Investigational Site Number 8400021 — Dallas, Texas, United States
• Investigational Site Number 8400029 — Lufkin, Texas, United States
• Investigational Site Number 8400034 — Seattle, Washington, United States
• Investigational Site Number 0320003 — Caba, Argentina
• Investigational Site Number 0320001 — Caba, Argentina
• Investigational Site Number 0320004 — Capital Federal, Argentina
• Investigational Site Number 0320002 — Capital Federal, Argentina
• Investigational Site Number 0320006 — Mendoza, Argentina
• Investigational Site Number 0320005 — Salta, Argentina
• Investigational Site Number 0320007 — San Miguel de Tucumán, Argentina
• Investigational Site Number 0760005 — Curitiba, Brazil
• Investigational Site Number 0760006 — Fortaleza, Brazil
• Investigational Site Number 0760004 — Fortaleza, Brazil
• Investigational Site Number 0760003 — Porto Alegre, Brazil
• Investigational Site Number 0760001 — São Paulo, Brazil
• Investigational Site Number 8400008 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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