E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10067584 |
E.1.2 | Term | Type 1 diabetes mellitus |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of HOE901-U300 to Lantus in terms of glycated hemoglobin (HbA1c) |
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E.2.2 | Secondary objectives of the trial |
-To compare HOE901-U300 and Lantus in terms of:
-Percentage of patients 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. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
STUDY No: EFC13957 – CGM sub-study
STUDY NAME: EDITION JUNIOR – CGM sub-study
OBJECTIVE: To compare glucose patterns of HOE901-U300 and Lantus over the 24-hour period between once daily administration in children and adolescents with type 1 diabetes mellitus (T1DM) during 7 days at Month 6 and Month 12. |
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E.3 | Principal 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 patient. |
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E.4 | Principal exclusion criteria |
-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.
-Patients using premix insulins in the last 3 months before screening visit or patients 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.
-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 are unwilling or unable to be tested for pregnancy. Abstinence from sexual intercourse will be considered as an acceptable form of birth control.
-Pregnant or breast-feeding adolescents, or adolescents who intend to become pregnant during the study period, or who are at risk of getting pregnant due to any psychosocial reason during the study period. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1- Percentage of patients with HbA1c values of <7.5% 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 on-treatment period
2- Change from baseline in FPG
3- Percentage of patients 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
4- Change from baseline in 24-hour mean plasma glucose based on 8-point self-monitored plasma glucose (SMPG) profiles
5- Change from baseline in variability of 24-hour mean plasma glucose based on 8-point SMPG profiles
6- Number (%) of patients with hypoglycemia
7- Number (%) of patients with hyperglycemia with ketosis
8- Number (%) of patients with adverse events |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- Week 26
2- Baseline; Week 26
3- Week 26
4- Baseline; Week 26
5- Baseline; Week 26
6- Up to Month 12
7- Up to Month 12
8- Up to Month 12 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Brazil |
Canada |
Chile |
Czech Republic |
Denmark |
France |
Germany |
Hungary |
Israel |
Italy |
Japan |
Latvia |
Mexico |
Poland |
Romania |
Russian Federation |
Spain |
Sweden |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 23 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 36 |