Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine

NCT02273180 | Completed Phase 3 Results

• 3 other identifiers: EFC126192013-002945-12U1111-1131-5038
• Study Type: interventional
• Target: 507
• Locations: 8 countries
• Sites: 89

Brief Summary

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated haemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 diabetes mellitus (T1DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study. To assess the relationship of anti-insulin antibodies with efficacy and safety including during the safety extension. To assess the efficacy of SAR342434 and Humalog in terms of proportion of participants reaching target HbA1c (\<7%), Fasting plasma glucose (FPG), self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline to Week 26

  Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data, using all post-baseline HbA1c data available during the main 6-month period and adequate contrasts at Week 26.

  Baseline, Week 26

Secondary Outcomes (7)

• Percentage of Participants With HbA1c <7.0% at Week 26

  Week 26

• Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

  Baseline, Week 26

• Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26

  Baseline, Week 26

• Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26

  Baseline, Week 26

• Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year

  First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

Other Outcomes (1)

• Change in Daily Insulin Dose From Baseline to Week 26 and Week 52

  Baseline, Week 26, Week 52

Study Arms (2)

SAR342434

EXPERIMENTAL

SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.

Drug: SAR342434; Drug: Insulin glargine HOE901

Humalog

ACTIVE COMPARATOR

Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.

Drug: Humalog; Drug: Insulin glargine HOE901

Interventions

SAR342434 DRUG

SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.

SAR342434

Humalog DRUG

Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia.

Also known as: Insulin Lispro

Humalog

Insulin glargine HOE901 DRUG

Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.

Also known as: Lantus

Humalog; SAR342434

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with T1DM diagnosed for at least 12 months and had been treated with insulin glargine and Humalog or Novolog®/Novo Rapid® (at least 3 times daily before each meal) in the 6 months prior to the screening visit.
• Written informed consent.

You may not qualify if:

• At screening visit, age under legal age of adulthood.
• HbA1c \<7.0% or \>10% at screening.
• Diabetes other than T1DM.
• Status post pancreatectomy.
• Status post pancreas and/or islet cell transplantation.
• Pregnancy and lactation.
• Women of childbearing potential not protected by highly effective contraceptive method of birth control.
• Less than 1 year on continuous insulin treatment.
• Use of insulin pump in the last 6 months before screening visit.
• Use of glucose lowering treatments other than insulin including non-insulin injectable peptides in the last 6 months prior to screening visit.
• Use of insulin other than insulin glargine and Humalog or Novolog/Novo Rapid as part of a multiple injection regimen (3 to 4 injections per day) in the last 6 months before screening visit. Liprolog® is a European Union approved insulin lispro and is allowed in those countries where it is marketed.
• Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) 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 (89)

Investigational Site Number 840049

Tucson, Arizona, 85714, United States

Location

Investigational Site Number 840016

Bell Gardens, California, 90201, United States

Location

Investigational Site Number 840048

Chula Vista, California, 91910, United States

Location

Investigational Site Number 840046

Concord, California, 94520, United States

Location

Investigational Site Number 840039

Fresno, California, 93720, United States

Location

Investigational Site Number 840028

La Jolla, California, 92037, United States

Location

Investigational Site Number 840022

Ventura, California, 93003, United States

Location

Investigational Site Number 840003

Denver, Colorado, 80209, United States

Location

Investigational Site Number 840037

Denver, Colorado, 80262, United States

Location

Investigational Site Number 840005

Bradenton, Florida, 34208, United States

Location

Investigational Site Number 840050

Miami, Florida, 33155, United States

Location

Investigational Site Number 840042

Miami, Florida, 33176, United States

Location

Investigational Site Number 840061

Miami Lakes, Florida, 33014, United States

Location

Investigational Site Number 840057

Miami Lakes, Florida, 33016, United States

Location

Investigational Site Number 840006

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840013

North Miami Beach, Florida, 33162, United States

Location

Investigational Site Number 840031

Port Charlotte, Florida, 33952, United States

Location

Investigational Site Number 840036

Atlanta, Georgia, 30318, United States

Location

Investigational Site Number 840045

Roswell, Georgia, 30076, United States

Location

Investigational Site Number 840020

Idaho Falls, Idaho, 83404, United States

Location

Investigational Site Number 840019

Chicago, Illinois, 60607, United States

Location

Investigational Site Number 840033

Chicago, Illinois, 60612, United States

Location

Investigational Site Number 840012

McHenry, Illinois, 60050, United States

Location

Investigational Site Number 840004

Des Moines, Iowa, 50314, United States

Location

Investigational Site Number 840043

Marrero, Louisiana, 70072, United States

Location

Investigational Site Number 840021

Metairie, Louisiana, 70006, United States

Location

Investigational Site Number 840038

Baltimore, Maryland, 21237, United States

Location

Investigational Site Number 840014

Rockville, Maryland, 20852, United States

Location

Investigational Site Number 840060

Great Falls, Montana, 59405, United States

Location

Investigational Site Number 840026

Omaha, Nebraska, 68114, United States

Location

Investigational Site Number 840040

Omaha, Nebraska, 68131, United States

Location

Investigational Site Number 840015

Albuquerque, New Mexico, 87106, United States

Location

Investigational Site Number 840054

Albuquerque, New Mexico, 87109, United States

Location

Investigational Site Number 840059

Mineola, New York, 11501, United States

Location

Investigational Site Number 840030

Burlington, North Carolina, 27215, United States

Location

Investigational Site Number 840051

Greenville, North Carolina, 27834, United States

Location

Investigational Site Number 840062

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 840018

Gallipolis, Ohio, 45631, United States

Location

Investigational Site Number 840007

Dakota Dunes, South Dakota, 57049, United States

Location

Investigational Site Number 840027

Rapid City, South Dakota, 57701, United States

Location

Investigational Site Number 840041

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840029

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840034

Dallas, Texas, 75246, United States

Location

Investigational Site Number 840002

Houston, Texas, 77090, United States

Location

Investigational Site Number 840011

Chesapeake, Virginia, 23321, United States

Location

Investigational Site Number 840023

Tacoma, Washington, 98415-0299, United States

Location

Investigational Site Number 840009

Milwaukee, Wisconsin, 53209-0996, United States

Location

Investigational Site Number 250002

Corbeil-Essonnes, 91100, France

Location

Investigational Site Number 250005

Mantes-la-Jolie, 78200, France

Location

Investigational Site Number 250003

Montpellier, 34295, France

Location

Investigational Site Number 250001

Vandœuvre-lès-Nancy, 54511, France

Location

Investigational Site Number 276001

Berlin, 10115, Germany

Location

Investigational Site Number 276004

Dortmund, 44137, Germany

Location

Investigational Site Number 276006

Hanover, 30159, Germany

Location

Investigational Site Number 276002

Heidelberg, 69115, Germany

Location

Investigational Site Number 276003

Neumünster, 24534, Germany

Location

Investigational Site Number 276008

Pirna, 01796, Germany

Location

Investigational Site Number 276007

Potsdam, 14469, Germany

Location

Investigational Site Number 276005

Sulzbach-Rosenberg, 92237, Germany

Location

Investigational Site Number 348002

Budapest, 1023, Hungary

Location

Investigational Site Number 348005

Budapest, 1033, Hungary

Location

Investigational Site Number 348003

Budapest, 1062, Hungary

Location

Investigational Site Number 348011

Budapest, 1062, Hungary

Location

Investigational Site Number 348010

Budapest, 1139, Hungary

Location

Investigational Site Number 348001

Budapest, 1213, Hungary

Location

Investigational Site Number 348007

Debrecen, 4031, Hungary

Location

Investigational Site Number 392006

Chūōku, Japan

Location

Investigational Site Number 392003

Higashiosaka-Shi, Japan

Location

Investigational Site Number 392004

Izumisano, Japan

Location

Investigational Site Number 392005

Kamakura-Shi, Japan

Location

Investigational Site Number 392001

Shinjuku-Ku, Japan

Location

Investigational Site Number 392002

Yamato-Shi, Japan

Location

Investigational Site Number 616005

Krakow, 31-501, Poland

Location

Investigational Site Number 616001

Poznan, 60-834, Poland

Location

Investigational Site Number 616003

Szczecin, 70-506, Poland

Location

Investigational Site Number 616002

Warsaw, 02-507, Poland

Location

Investigational Site Number 616004

Zabrze, 41-800, Poland

Location

Investigational Site Number 643003

Moscow, 117036, Russia

Location

Investigational Site Number 643004

Saint Petersburg, 190068, Russia

Location

Investigational Site Number 643001

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643005

Saint Petersburg, 195257, Russia

Location

Investigational Site Number 643006

Samara, 443041, Russia

Location

Investigational Site Number 643002

Saratov, 410030, Russia

Location

Investigational Site Number 643007

Tomsk, 634050, Russia

Location

Investigational Site Number 724002

A Coruña, 15006, Spain

Location

Investigational Site Number 724001

Cáceres, 10003, Spain

Location

Investigational Site Number 724004

Lleida, 25198, Spain

Location

Investigational Site Number 724005

Málaga, 29010, Spain

Location

Investigational Site Number 724003

Sabadell, 08208, Spain

Location

Related Publications (1)

• Garg SK, Wernicke-Panten K, Rojeski M, Pierre S, Kirchhein Y, Jedynasty K. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. Diabetes Technol Ther. 2017 Sep;19(9):516-526. doi: 10.1089/dia.2017.0117. Epub 2017 Aug 30.

  PMID: 28722480 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

SAR342434; Insulin Lispro; 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, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

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: October 21, 2014
• First Posted: October 23, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: July 1, 2016
• Last Updated: January 18, 2018
• Results First Posted: January 18, 2018

Record last verified: 2017-12

Locations

HU (7); DE (8); US (47); FR (4); RU (7); ES (5); PL (5); JP (6)