Phase 3
Completed N=463
Comparison of the Safety and Efficacy of HOE901-U300 With Lantus in Children and Adolescents With Type 1 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02735044 ↗Enrolled (actual)
463
Serious AEs
14.3%
Results posted
Jun 2019
Primary outcomePrimary: Change From Baseline in HbA1c to Month 6 — -0.399; -0.402 Percentage of HbA1c — p=0.965
◆ Published Evidence
Established
27citations · ~5 / year
Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial.
Summary
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.
Linked Publications
-
Efficacy and Safety of Insulin Glargine 300 Units/mL (Gla-300) Versus Insulin Glargine 100 Units/mL (Gla-100) in Children and Adolescents (6-17 years) With Type 1 Diabetes: Results of the EDITION JUNIOR Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in HbA1c to Month 6 |
-0.399; -0.402 | 0.965 |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6 |
-0.563; -0.549 | — |
| SECONDARY Percentage of Participants With HbA1c Values of <7.5% at Month 6 |
26.18; 23.48 | — |
| SECONDARY Percentage of Participants With HbA1c Values of <7.5% Without Any Episode of Severe and/or Documented Self-Monitored Plasma Glucose ([SMPG] <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period |
4.29; 4.78 | — |
| SECONDARY Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6 |
27.47; 26.52 | — |
| SECONDARY Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) Without Any Episode of Severe and/or Documented (SMPG <54 mg/dL [3.0 mmol/L]) Symptomatic Hypoglycemia During the Last 3 Months of the Main 6-month Randomized Period |
9.44; 7.39 | — |
| SECONDARY Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6 |
0.139; -0.266 | — |
| SECONDARY Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6 |
1.469; 0.789 | — |
| SECONDARY Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point |
0.84; -0.60; -0.41; -1.71; -0.26; -0.62 | — |
| SECONDARY Percentage of Participants With at Least One Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Symptomatic, Probable Symptomatic, Asymptomatic Hypoglycemia, Pseudo-hypoglycemia and Severe and/or Confirmed Hypoglycemia) at Month 12 |
99.1; 98.7; 8.6; 11.0; 94.8; 93.9 | — |
| SECONDARY Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12 |
9.9; 13.6 | — |
Eligibility Criteria
Inclusion criteria
- 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.
Exclusion criteria
- Age =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 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.
Data sourced from ClinicalTrials.gov (NCT02735044) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.