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Type 1 Diabetes MellitusPhase 3EDITION JUNIORNCT02735044

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

A Phase 3 study testing Insulin glargine,300 U/mL, Insulin glargine (100 units /mL) and Background therapy in people with Type 1 Diabetes Mellitus, run by Sanofi at 107 sites in 24 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. . Read more about this study

Who is it for?
Ages 6 to 17 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Insulin glargine,300 U/mL, Insulin glargine (100 units /mL) and Background therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
463 participants
Where
107 sitesin 24 countries
Study dates
14 Apr 2016to 20 Dec 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

107 sites in 24 countries.

107 sites in 24 countries

United States13 sites

  • Investigational Site Number 8400037

    Atlanta, Georgia, 30318

  • Investigational Site Number 8400015

    Buffalo, New York, 14222

  • Investigational Site Number 8400016

    Chapel Hill, North Carolina, 27599-7295

  • Investigational Site Number 8400005

    Dallas, Texas, 75231

  • Investigational Site Number 8400021

    Dallas, Texas, 75235

  • Investigational Site Number 8400032

    Indianapolis, Indiana, 46202

  • Investigational Site Number 8400029

    Lufkin, Texas, 75904

  • Investigational Site Number 8400035

    Morehead City, North Carolina, 28557

  • Investigational Site Number 8400038

    Oklahoma City, Oklahoma, 73112

  • Investigational Site Number 8400030

    Philadelphia, Pennsylvania, 19104

  • Investigational Site Number 8400010

    Rapid City, South Dakota, 57701

  • Investigational Site Number 8400034

    Seattle, Washington, 98105

  • Investigational Site Number 8400008

    Tucson, Arizona, 85724

Other trials in United States

Argentina7 sites

  • Investigational Site Number 0320003

    Caba, C1180AAX

  • Investigational Site Number 0320001

    Caba, C1270AAN

  • Investigational Site Number 0320004

    Capital Federal, C1179AAB

  • Investigational Site Number 0320002

    Capital Federal, C1425DUC

  • Investigational Site Number 0320006

    Mendoza, 5500

  • Investigational Site Number 0320005

    Salta, 4400

  • Investigational Site Number 0320007

    San Miguel de Tucumán, 4107

Other trials in Argentina

Hungary7 sites

  • Investigational Site Number 3480001

    Budapest, 1036

  • Investigational Site Number 3480004

    Budapest, 1083

  • Investigational Site Number 3480003

    Budapest, 1089

  • Investigational Site Number 3480005

    Gyula, 5700

  • Investigational Site Number 3480002

    Miskolc, 3529

  • Investigational Site Number 3480006

    Pécs, 7623

  • Investigational Site Number 3480007

    Székesfehérvár, 8000

Other trials in Hungary

Brazil6 sites

  • Investigational Site Number 0760005

    Curitiba, 80810-040

  • Investigational Site Number 0760006

    Fortaleza, 60115-282

  • Investigational Site Number 0760004

    Fortaleza, 60430-350

  • Investigational Site Number 0760003

    Porto Alegre, 91350-250

  • Investigational Site Number 0760001

    São Paulo, 04022-001

  • Investigational Site Number 0760002

    São Paulo

Other trials in Brazil

Japan6 sites

  • Investigational Site Number 3920006

    Chiyoda-Ku

  • Investigational Site Number 3920002

    Fukuoka

  • Investigational Site Number 3920003

    Hiroshima

  • Investigational Site Number 3920007

    Kobe

  • Investigational Site Number 3920005

    Osaka

  • Investigational Site Number 3920004

    Shinjuku-Ku

Other trials in Japan

Poland6 sites

  • Investigational Site Number 6160005

    Bielsko-Biala, 43-316

  • Investigational Site Number 6160001

    Gdansk, 80-952

  • Investigational Site Number 6160006

    Szczecin, 71-252

  • Investigational Site Number 6160007

    Warsaw, 02-091

  • Investigational Site Number 6160004

    Warsaw, 04-730

  • Investigational Site Number 6160003

    Warsaw, 04-736

Other trials in Poland

Spain6 sites

  • Investigational Site Number 7240005

    Barcelona, 08035

  • Investigational Site Number 7240002

    Barcelona, 08041

  • Investigational Site Number 7240003

    Esplugues de Llobregat, 08950

  • Investigational Site Number 7240004

    Sabadell, 08208

  • Investigational Site Number 7240006

    Santa Cruz de Tenerife, 38320

  • Investigational Site Number 7240001

    Vitoria-Gasteiz, 01009

Other trials in Spain

Chile5 sites

  • Investigational Site Number 1520002

    Santiago, 8207257

  • Investigational Site Number 1520004

    Santiago, 8330074

  • Investigational Site Number 1520006

    Santiago

  • Investigational Site Number 1520007

    Temuco, 4813299

  • Investigational Site Number 1520003

    Viña del Mar

Other trials in Chile

Italy5 sites

  • Investigational Site Number 3800001

    Florence, 50139

  • Investigational Site Number 3800005

    Roma, 00165

  • Investigational Site Number 3800004

    Torino, 10126

  • Investigational Site Number 3800006

    Varese, 21100

  • Investigational Site Number 3800003

    Verona, 37134

Other trials in Italy

Mexico5 sites

  • Investigational Site Number 4840003

    Durango, 34000

  • Investigational Site Number 4840004

    México, 06700

  • Investigational Site Number 4840001

    Monterrey, 64460

  • Investigational Site Number 4840002

    Puebla City, 72190

  • Investigational Site Number 4840005

    Veracruz, 91910

Other trials in Mexico

Romania5 sites

  • Investigational Site Number 6420005

    Bucharest, 041451

  • Investigational Site Number 6420007

    Constanța, 900591

  • Investigational Site Number 6420004

    Craiova, 200542

  • Investigational Site Number 6420006

    Sibiu, 550166

  • Investigational Site Number 6420003

    Timișoara, 300011

Other trials in Romania

Canada4 sites

  • Investigational Site Number 1240003

    Halifax, B3K6R8

  • Investigational Site Number 1240002

    Montreal, H1T 2M4

  • Investigational Site Number 1240005

    Montreal, H3T 1C5

  • Investigational Site Number 1240006

    Sherbrooke, J1H 5N4

Other trials in Canada

Germany4 sites

  • Investigational Site Number 2760002

    Hanover, 30173

  • Investigational Site Number 2760001

    Heidelberg, 69120

  • Investigational Site Number 2760004

    Leipzig, 04103

  • Investigational Site Number 2760003

    Münster, 48155

Other trials in Germany

Israel4 sites

  • Investigational Site Number 3760003

    Beersheba, 84101

  • Investigational Site Number 3760001

    Haifa, 31096

  • Investigational Site Number 3760006

    Holon, 58100

  • Investigational Site Number 3760002

    Petah Tikva

Other trials in Israel

Russia4 sites

  • Investigational Site Number 6430001

    Moscow, 117036

  • Investigational Site Number 6430002

    Saint Petersburg, 193144

  • Investigational Site Number 6430004

    Smolensk, 214018

  • Investigational Site Number 6430003

    Ufa, 450000

Other trials in Russia

United Kingdom4 sites

  • Investigational Site Number 8260005

    Doncaster, DN2 5LT

  • Investigational Site Number 8260001

    Ipswich, IP4 5PD

  • Investigational Site Number 8260004

    Kettering, NN16 8UZ

  • Investigational Site Number 8260002

    Salisbury, SP2 8BJ

Other trials in United Kingdom

Bulgaria3 sites

  • Investigational Site Number 1000001

    Plovdiv, 4000

  • Investigational Site Number 1000005

    Sofia, 1784

  • Investigational Site Number 1000004

    Varna, 9000

Other trials in Bulgaria

Czechia3 sites

  • Investigational Site Number 2030003

    Hradec Králové, 500 05

  • Investigational Site Number 2030005

    Ostrava - Poruba, 70852

  • Investigational Site Number 2030001

    Praha 5 - Motol, 15006

Other trials in Czechia

Serbia3 sites

  • Investigational Site Number 6880002

    Belgrade, 11000

  • Investigational Site Number 6880003

    Belgrade, 11000

  • Investigational Site Number 6880004

    Niš, 18000

Other trials in Serbia

France2 sites

  • Investigational Site Number 2500003

    Montpellier, 34295

  • Investigational Site Number 2500002

    Toulouse, 31059

Other trials in France

Latvia2 sites

  • Investigational Site Number 4280002

    Daugavpils, LV-5417

  • Investigational Site Number 4280001

    Riga, LV-1004

Other trials in Latvia

Denmark1 site

  • Investigational Site Number 2080001

    Herlev, 2730

Other trials in Denmark

North Macedonia1 site

  • Investigational Site Number 8070001

    Skopje, 1000

Other trials in North Macedonia

Sweden1 site

  • Investigational Site Number 7520002

    Stockholm, 118 83

Other trials in Sweden

About this study

Official title: 6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and Adolescents Age 6 - 17 Years With Type 1 Diabetes Mellitus With a 6-month Safety Extension Period

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.
Read the detailed description

The study duration per participant was approximately 58 weeks that consisted of a 2 week screening period, a main 6-month comparative efficacy and safety treatment period, a 6-month comparative safety extension period, and a 4-week post treatment follow up period.

Being tested
Insulin glargine,300 U/mL, Insulin glargine (100 units /mL), Background therapy
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine,300 U/mLDrug

    Also called Toujeo ®

    Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter [mmol/L])

  • Insulin glargine (100 units /mL)Drug

    Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L)

  • Background therapyDrug

    Fast-acting mealtime insulin analogs

Study groups in NCT02735044
Study groupRoleWhat they receive
HOE901-U300ExperimentalHOE901-U300 (Insulin glargine 300 Units/milliliter [U/mL]) Subcutaneous(SC) injection once daily for 12 months.
Receives: Drug: Insulin glargine,300 U/mL; Drug: Background therapy
LantusActive comparatorLantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months.
Receives: Drug: Insulin glargine (100 units /mL); Drug: Background therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c to Month 6

    Change in HbA1c was calculated by subtracting baseline value from Month 6 value. Adjusted least-square (LS) means and standard errors (SE) were obtained using analysis of covariance (ANCOVA) after multiple imputations of missing data using post-baseline HbA1c data available on the main 6-month randomized period.

    Measured: Baseline to Month 6

Secondary outcomes (10)

  1. Change From Baseline in Fasting Plasma Glucose (FPG) to Month 6

    Change in FPG was calculated by subtracting baseline value from Month 6 value. Adjusted LS means and SE were obtained using ANCOVA after multiple imputation to address missing data in the main 6 month randomized period.

    Measured: Baseline to Month 6

  2. Percentage of Participants With HbA1c Values of <7.5% at Month 6

    Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

    Measured: Month 6

  3. 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

    Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

    Measured: upto Month 6

  4. Percentage of Participants With FPG of <=130 mg/dL (7.2 mmol/L) at Month 6

    Participants without any available FPG assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

    Measured: Month 6

  5. 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

    Participants without any available HbA1c assessment at month 6 and/or with a premature study discontinuation during the main 6-month randomized period were considered as a failure (non-responders) in the analysis. Analysis was performed using Cochran-Mantel-Haenszel (CMH) method with randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

    Measured: upto Month 6

  6. Change From Baseline in 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles to Month 6

    8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%), randomization strata of age at screening (<12 years, >=12 years) and the baseline 24-hour average 8-point profile SMPG.

    Measured: Baseline to Month 6

  7. Change From Baseline in Variability of 24-Hour Mean Plasma Glucose Based on 8-point SMPG Profiles at Month 6

    8-point SMPG profiles were measured at the following 8 points: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Variability was assessed by the coefficient of variation (standard deviation divided by mean) calculated over the 8-point SMPG. Analysis was performed using a ANCOVA model including the fixed categorical effects of treatment group, randomization strata of screening HbA1c (<8.5%; >=8.5%) and randomization strata of age at screening (<12 years, >=12 years).

    Measured: Baseline, Month 6

  8. Change From Baseline to Month 6 in 8-Point SMPG Profile Per Time Point

    8-point SMPG profiles were measured for following 8 time points at Baseline and Month 6: between 01:00 and 04:00 (clock time) at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.

    Measured: Baseline to Month 6

  9. 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

    Severe hypoglycemia: an event in which the child/adolescent having altered mental status and cannot assist in their care, is semiconscious or unconscious, or in coma ± convulsions and may require parenteral therapy (glucagon or glucose). Documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose concentration <=70 mg/dL. Probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia were not accompanied by plasma glucose determination but was presumably caused by a plasma glucose concentration <=70 mg/dL. Pseudo-hypoglycemia:an event with any of the typical symptoms of hypoglycaemia with plasma glucose concentration >70 mg/dL.

    Measured: Month 12

  10. Percentage of Participants With Any Hyperglycemia With Ketosis at Month 12

    Hyperglycemia with ketosis was defined as SMPG >=252 mg/dL (14 mmol/L) with accompanying self-measured blood ketones >=1.5 mmol/L.

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2016 (estimated)
  2. Study start14 Apr 2016
  3. Primary completion31 May 2018
  4. Study completion20 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
463 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02735044
Sponsor's protocol ID
EFC13957
Other IDs
2015-002084-42, U1111-1168-4546, 2015
Acronym
EDITION JUNIOR
Status last verified
Mar 2022
First submitted
30 Mar 2016
Last updated
25 Mar 2022
Data monitoring committee
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Danne T, Tamborlane WV, Malievsky OA, Franco DR, Kawamura T, Demissie M, Niemoeller E, Goyeau H, Wardecki M, Battelino T. 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. Diabetes Care. 2020 Jul;43(7):1512-1519. doi: 10.2337/dc19-1926. Epub 2020 May 19.

    PubMed 32430458

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glargine,300 U/mL, Insulin glargine (100 units /mL) and Background therapy in people with Type 1 Diabetes Mellitus, run by Sanofi at 107 sites in 24 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 107 sites in United States, Argentina, Hungary, Brazil, Japan and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c to Month 6 (time frame: Baseline to Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02735044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.

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