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

NCT02735044 | Completed Phase 3 Results

• 3 other identifiers: EFC139572015-002084-42U1111-1168-4546
• Study Type: interventional
• Target: 463
• Locations: 23 countries
• Sites: 104

Brief 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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

  Baseline to Month 6

Secondary Outcomes (10)

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

  Baseline to Month 6

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

  Month 6

• 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

  upto Month 6

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

  Month 6

• 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

  upto Month 6

Study Arms (2)

HOE901-U300

EXPERIMENTAL

HOE901-U300 (Insulin glargine 300 Units/milliliter \[U/mL\]) Subcutaneous(SC) injection once daily for 12 months.

Drug: Insulin glargine,300 U/mL; Drug: Background therapy

Lantus

ACTIVE COMPARATOR

Lantus (Insulin glargine 100 U/mL) SC injection once daily for 12 months.

Drug: Insulin glargine (100 units /mL); Drug: Background therapy

Interventions

Insulin glargine,300 U/mL DRUG

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 \[mmol/L\])

Also known as: Toujeo ®

HOE901-U300

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)

Lantus

Background therapy DRUG

Fast-acting mealtime insulin analogs

HOE901-U300; Lantus

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (107)

Investigational Site Number 8400008

Tucson, Arizona, 85724, United States

Location

Investigational Site Number 8400037

Atlanta, Georgia, 30318, United States

Location

Investigational Site Number 8400032

Indianapolis, Indiana, 46202, United States

Location

Investigational Site Number 8400015

Buffalo, New York, 14222, United States

Location

Investigational Site Number 8400016

Chapel Hill, North Carolina, 27599-7295, United States

Location

Investigational Site Number 8400035

Morehead City, North Carolina, 28557, United States

Location

Investigational Site Number 8400038

Oklahoma City, Oklahoma, 73112, United States

Location

Investigational Site Number 8400030

Philadelphia, Pennsylvania, 19104, United States

Location

Investigational Site Number 8400010

Rapid City, South Dakota, 57701, United States

Location

Investigational Site Number 8400005

Dallas, Texas, 75231, United States

Location

Investigational Site Number 8400021

Dallas, Texas, 75235, United States

Location

Investigational Site Number 8400029

Lufkin, Texas, 75904, United States

Location

Investigational Site Number 8400034

Seattle, Washington, 98105, United States

Location

Investigational Site Number 0320003

Caba, C1180AAX, Argentina

Location

Investigational Site Number 0320001

Caba, C1270AAN, Argentina

Location

Investigational Site Number 0320004

Capital Federal, C1179AAB, Argentina

Location

Investigational Site Number 0320002

Capital Federal, C1425DUC, Argentina

Location

Investigational Site Number 0320006

Mendoza, 5500, Argentina

Location

Investigational Site Number 0320005

Salta, 4400, Argentina

Location

Investigational Site Number 0320007

San Miguel de Tucumán, 4107, Argentina

Location

Investigational Site Number 0760005

Curitiba, 80810-040, Brazil

Location

Investigational Site Number 0760006

Fortaleza, 60115-282, Brazil

Location

Investigational Site Number 0760004

Fortaleza, 60430-350, Brazil

Location

Investigational Site Number 0760003

Porto Alegre, 91350-250, Brazil

Location

Investigational Site Number 0760001

São Paulo, 04022-001, Brazil

Location

Investigational Site Number 0760002

São Paulo, Brazil

Location

Investigational Site Number 1000001

Plovdiv, 4000, Bulgaria

Location

Investigational Site Number 1000005

Sofia, 1784, Bulgaria

Location

Investigational Site Number 1000004

Varna, 9000, Bulgaria

Location

Investigational Site Number 1240003

Halifax, B3K6R8, Canada

Location

Investigational Site Number 1240002

Montreal, H1T 2M4, Canada

Location

Investigational Site Number 1240005

Montreal, H3T 1C5, Canada

Location

Investigational Site Number 1240006

Sherbrooke, J1H 5N4, Canada

Location

Investigational Site Number 1520002

Santiago, 8207257, Chile

Location

Investigational Site Number 1520004

Santiago, 8330074, Chile

Location

Investigational Site Number 1520006

Santiago, Chile

Location

Investigational Site Number 1520007

Temuco, 4813299, Chile

Location

Investigational Site Number 1520003

Viña del Mar, Chile

Location

Investigational Site Number 2030003

Hradec Králové, 500 05, Czechia

Location

Investigational Site Number 2030005

Ostrava - Poruba, 70852, Czechia

Location

Investigational Site Number 2030001

Praha 5 - Motol, 15006, Czechia

Location

Investigational Site Number 2080001

Herlev, 2730, Denmark

Location

Investigational Site Number 2500003

Montpellier, 34295, France

Location

Investigational Site Number 2500002

Toulouse, 31059, France

Location

Investigational Site Number 2760002

Hanover, 30173, Germany

Location

Investigational Site Number 2760001

Heidelberg, 69120, Germany

Location

Investigational Site Number 2760004

Leipzig, 04103, Germany

Location

Investigational Site Number 2760003

Münster, 48155, Germany

Location

Investigational Site Number 3480001

Budapest, 1036, Hungary

Location

Investigational Site Number 3480004

Budapest, 1083, Hungary

Location

Investigational Site Number 3480003

Budapest, 1089, Hungary

Location

Investigational Site Number 3480005

Gyula, 5700, Hungary

Location

Investigational Site Number 3480002

Miskolc, 3529, Hungary

Location

Investigational Site Number 3480006

Pécs, 7623, Hungary

Location

Investigational Site Number 3480007

Székesfehérvár, 8000, Hungary

Location

Investigational Site Number 3760003

Beersheba, 84101, Israel

Location

Investigational Site Number 3760001

Haifa, 31096, Israel

Location

Investigational Site Number 3760006

Holon, 58100, Israel

Location

Investigational Site Number 3760002

Petah Tikva, Israel

Location

Investigational Site Number 3800001

Florence, 50139, Italy

Location

Investigational Site Number 3800005

Roma, 00165, Italy

Location

Investigational Site Number 3800004

Torino, 10126, Italy

Location

Investigational Site Number 3800006

Varese, 21100, Italy

Location

Investigational Site Number 3800003

Verona, 37134, Italy

Location

Investigational Site Number 3920006

Chiyoda-Ku, Japan

Location

Investigational Site Number 3920002

Fukuoka, Japan

Location

Investigational Site Number 3920003

Hiroshima, Japan

Location

Investigational Site Number 3920007

Kobe, Japan

Location

Investigational Site Number 3920005

Osaka, Japan

Location

Investigational Site Number 3920004

Shinjuku-Ku, Japan

Location

Investigational Site Number 4280002

Daugavpils, LV-5417, Latvia

Location

Investigational Site Number 4280001

Riga, LV-1004, Latvia

Location

Investigational Site Number 4840003

Durango, 34000, Mexico

Location

Investigational Site Number 4840004

México, 06700, Mexico

Location

Investigational Site Number 4840001

Monterrey, 64460, Mexico

Location

Investigational Site Number 4840002

Puebla City, 72190, Mexico

Location

Investigational Site Number 4840005

Veracruz, 91910, Mexico

Location

Investigational Site Number 8070001

Skopje, 1000, North Macedonia

Location

Investigational Site Number 6160005

Bielsko-Biala, 43-316, Poland

Location

Investigational Site Number 6160001

Gdansk, 80-952, Poland

Location

Investigational Site Number 6160006

Szczecin, 71-252, Poland

Location

Investigational Site Number 6160007

Warsaw, 02-091, Poland

Location

Investigational Site Number 6160004

Warsaw, 04-730, Poland

Location

Investigational Site Number 6160003

Warsaw, 04-736, Poland

Location

Investigational Site Number 6420005

Bucharest, 041451, Romania

Location

Investigational Site Number 6420007

Constanța, 900591, Romania

Location

Investigational Site Number 6420004

Craiova, 200542, Romania

Location

Investigational Site Number 6420006

Sibiu, 550166, Romania

Location

Investigational Site Number 6420003

Timișoara, 300011, Romania

Location

Investigational Site Number 6430001

Moscow, 117036, Russia

Location

Investigational Site Number 6430002

Saint Petersburg, 193144, Russia

Location

Investigational Site Number 6430004

Smolensk, 214018, Russia

Location

Investigational Site Number 6430003

Ufa, 450000, Russia

Location

Investigational Site Number 6880002

Belgrade, 11000, Serbia

Location

Investigational Site Number 6880003

Belgrade, 11000, Serbia

Location

Investigational Site Number 6880004

Niš, 18000, Serbia

Location

Investigational Site Number 7240005

Barcelona, 08035, Spain

Location

Investigational Site Number 7240002

Barcelona, 08041, Spain

Location

Investigational Site Number 7240003

Esplugues de Llobregat, 08950, Spain

Location

Investigational Site Number 7240004

Sabadell, 08208, Spain

Location

Investigational Site Number 7240006

Santa Cruz de Tenerife, 38320, Spain

Location

Investigational Site Number 7240001

Vitoria-Gasteiz, 01009, Spain

Location

Investigational Site Number 7520002

Stockholm, 118 83, Sweden

Location

Investigational Site Number 8260005

Doncaster, DN2 5LT, United Kingdom

Location

Investigational Site Number 8260001

Ipswich, IP4 5PD, United Kingdom

Location

Investigational Site Number 8260004

Kettering, NN16 8UZ, United Kingdom

Location

Investigational Site Number 8260002

Salisbury, SP2 8BJ, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32430458 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

None reported

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi aventis recherche & développement

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2016
• First Posted: April 12, 2016
• Study Start: April 14, 2016
• Primary Completion: May 31, 2018
• Study Completion: December 20, 2018
• Last Updated: March 25, 2022
• Results First Posted: June 19, 2019

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (1); CZ (3); HU (7); IL (4); ES (6); BR (6); ME (5); GB (4); PL (6); RU (4); CA (4); LA (2); US (13); JP (6); FR (2); DK (1); NO (1); CL (5); DE (4); IT (5); AR (7); RO (5); BU (3)