Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
NCT ID: NCT02273180
Last Updated: 2018-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
507 participants
INTERVENTIONAL
2014-10-31
2016-07-31
Brief Summary
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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.
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Detailed Description
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* Up to 2 weeks screening period
* 26-week treatment period
* 26-week comparative safety extension period
* 1-day follow-up period
* The maximum study duration would be 54 weeks per participant and a 1-day safety follow-up
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SAR342434
SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
SAR342434
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.
Insulin glargine HOE901
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.
Humalog
Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
Humalog
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.
Insulin glargine HOE901
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.
Interventions
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SAR342434
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.
Humalog
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.
Insulin glargine HOE901
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840049
Tucson, Arizona, United States
Investigational Site Number 840016
Bell Gardens, California, United States
Investigational Site Number 840048
Chula Vista, California, United States
Investigational Site Number 840046
Concord, California, United States
Investigational Site Number 840039
Fresno, California, United States
Investigational Site Number 840028
La Jolla, California, United States
Investigational Site Number 840022
Ventura, California, United States
Investigational Site Number 840003
Denver, Colorado, United States
Investigational Site Number 840037
Denver, Colorado, United States
Investigational Site Number 840005
Bradenton, Florida, United States
Investigational Site Number 840050
Miami, Florida, United States
Investigational Site Number 840042
Miami, Florida, United States
Investigational Site Number 840061
Miami Lakes, Florida, United States
Investigational Site Number 840057
Miami Lakes, Florida, United States
Investigational Site Number 840006
New Port Richey, Florida, United States
Investigational Site Number 840013
North Miami Beach, Florida, United States
Investigational Site Number 840031
Port Charlotte, Florida, United States
Investigational Site Number 840036
Atlanta, Georgia, United States
Investigational Site Number 840045
Roswell, Georgia, United States
Investigational Site Number 840020
Idaho Falls, Idaho, United States
Investigational Site Number 840019
Chicago, Illinois, United States
Investigational Site Number 840033
Chicago, Illinois, United States
Investigational Site Number 840012
McHenry, Illinois, United States
Investigational Site Number 840004
Des Moines, Iowa, United States
Investigational Site Number 840043
Marrero, Louisiana, United States
Investigational Site Number 840021
Metairie, Louisiana, United States
Investigational Site Number 840038
Baltimore, Maryland, United States
Investigational Site Number 840014
Rockville, Maryland, United States
Investigational Site Number 840060
Great Falls, Montana, United States
Investigational Site Number 840026
Omaha, Nebraska, United States
Investigational Site Number 840040
Omaha, Nebraska, United States
Investigational Site Number 840015
Albuquerque, New Mexico, United States
Investigational Site Number 840054
Albuquerque, New Mexico, United States
Investigational Site Number 840059
Mineola, New York, United States
Investigational Site Number 840030
Burlington, North Carolina, United States
Investigational Site Number 840051
Greenville, North Carolina, United States
Investigational Site Number 840062
Wilmington, North Carolina, United States
Investigational Site Number 840018
Gallipolis, Ohio, United States
Investigational Site Number 840007
Dakota Dunes, South Dakota, United States
Investigational Site Number 840027
Rapid City, South Dakota, United States
Investigational Site Number 840041
Dallas, Texas, United States
Investigational Site Number 840029
Dallas, Texas, United States
Investigational Site Number 840034
Dallas, Texas, United States
Investigational Site Number 840002
Houston, Texas, United States
Investigational Site Number 840011
Chesapeake, Virginia, United States
Investigational Site Number 840023
Tacoma, Washington, United States
Investigational Site Number 840009
Milwaukee, Wisconsin, United States
Investigational Site Number 250002
Corbeil-Essonnes, , France
Investigational Site Number 250005
Mantes-la-Jolie, , France
Investigational Site Number 250003
Montpellier, , France
Investigational Site Number 250001
Vandœuvre-lès-Nancy, , France
Investigational Site Number 276001
Berlin, , Germany
Investigational Site Number 276004
Dortmund, , Germany
Investigational Site Number 276006
Hanover, , Germany
Investigational Site Number 276002
Heidelberg, , Germany
Investigational Site Number 276003
Neumünster, , Germany
Investigational Site Number 276008
Pirna, , Germany
Investigational Site Number 276007
Potsdam, , Germany
Investigational Site Number 276005
Sulzbach-Rosenberg, , Germany
Investigational Site Number 348002
Budapest, , Hungary
Investigational Site Number 348005
Budapest, , Hungary
Investigational Site Number 348003
Budapest, , Hungary
Investigational Site Number 348011
Budapest, , Hungary
Investigational Site Number 348010
Budapest, , Hungary
Investigational Site Number 348001
Budapest, , Hungary
Investigational Site Number 348007
Debrecen, , Hungary
Investigational Site Number 392006
Chūōku, , Japan
Investigational Site Number 392003
Higashiosaka-Shi, , Japan
Investigational Site Number 392004
Izumisano, , Japan
Investigational Site Number 392005
Kamakura-Shi, , Japan
Investigational Site Number 392001
Shinjuku-Ku, , Japan
Investigational Site Number 392002
Yamato-Shi, , Japan
Investigational Site Number 616005
Krakow, , Poland
Investigational Site Number 616001
Poznan, , Poland
Investigational Site Number 616003
Szczecin, , Poland
Investigational Site Number 616002
Warsaw, , Poland
Investigational Site Number 616004
Zabrze, , Poland
Investigational Site Number 643003
Moscow, , Russia
Investigational Site Number 643004
Saint Petersburg, , Russia
Investigational Site Number 643001
Saint Petersburg, , Russia
Investigational Site Number 643005
Saint Petersburg, , Russia
Investigational Site Number 643006
Samara, , Russia
Investigational Site Number 643002
Saratov, , Russia
Investigational Site Number 643007
Tomsk, , Russia
Investigational Site Number 724002
A Coruña, , Spain
Investigational Site Number 724001
Cáceres, , Spain
Investigational Site Number 724004
Lleida, , Spain
Investigational Site Number 724005
Málaga, , Spain
Investigational Site Number 724003
Sabadell, , Spain
Countries
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References
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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.
Other Identifiers
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2013-002945-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1131-5038
Identifier Type: OTHER
Identifier Source: secondary_id
EFC12619
Identifier Type: -
Identifier Source: org_study_id
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