Clinical trial NCT02273180: Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Official title: Six-Month, Randomized, Open-Label, Parallel-group Comparison of SAR342434 to Humalog® in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine, With a 6-month Safety Extension Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study consisted of a:

* 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

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Change in HbA1c From Baseline to Week 26
timeFrame: Baseline, Week 26
Secondary outcomes:
measure: Percentage of Participants With HbA1c <7.0% at Week 26
timeFrame: Week 26
measure: Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year
timeFrame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
measure: Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
timeFrame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
measure: Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)
timeFrame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Other outcomes:
measure: Change in Daily Insulin Dose From Baseline to Week 26 and Week 52
timeFrame: Baseline, Week 26, Week 52
Locations:
city: Tucson
country: United States
facility: Investigational Site Number 840049
state: Arizona
city: Bell Gardens
country: United States
facility: Investigational Site Number 840016
state: California
city: Chula Vista
country: United States
facility: Investigational Site Number 840048
state: California
city: Concord
country: United States
facility: Investigational Site Number 840046
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840039
state: California
city: La Jolla
country: United States
facility: Investigational Site Number 840028
state: California
city: Ventura
country: United States
facility: Investigational Site Number 840022
state: California
city: Denver
country: United States
facility: Investigational Site Number 840003
state: Colorado
city: Denver
country: United States
facility: Investigational Site Number 840037
state: Colorado
city: Bradenton
country: United States
facility: Investigational Site Number 840005
state: Florida
city: Miami Lakes
country: United States
facility: Investigational Site Number 840061
state: Florida
city: Miami Lakes
country: United States
facility: Investigational Site Number 840057
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840050
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840042
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840006
state: Florida
city: North Miami Beach
country: United States
facility: Investigational Site Number 840013
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 840031
state: Florida
city: Atlanta
country: United States
facility: Investigational Site Number 840036
state: Georgia
city: Roswell
country: United States
facility: Investigational Site Number 840045
state: Georgia
city: Idaho Falls
country: United States
facility: Investigational Site Number 840020
state: Idaho
city: Chicago
country: United States
facility: Investigational Site Number 840019
state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840033
state: Illinois
city: McHenry
country: United States
facility: Investigational Site Number 840012
state: Illinois
city: Des Moines
country: United States
facility: Investigational Site Number 840004
state: Iowa
city: Marrero
country: United States
facility: Investigational Site Number 840043
state: Louisiana
city: Metairie
country: United States
facility: Investigational Site Number 840021
state: Louisiana
city: Baltimore
country: United States
facility: Investigational Site Number 840038
state: Maryland
city: Rockville
country: United States
facility: Investigational Site Number 840014
state: Maryland
city: Great Falls
country: United States
facility: Investigational Site Number 840060
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840026
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840040
state: Nebraska
city: Albuquerque
country: United States
facility: Investigational Site Number 840015
state: New Mexico
city: Albuquerque
country: United States
facility: Investigational Site Number 840054
state: New Mexico
city: Mineola
country: United States
facility: Investigational Site Number 840059
state: New York
city: Burlington
country: United States
facility: Investigational Site Number 840030
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840051
state: North Carolina
city: Wilmington
country: United States
facility: Investigational Site Number 840062
state: North Carolina
city: Gallipolis
country: United States
facility: Investigational Site Number 840018
state: Ohio
city: Dakota Dunes
country: United States
facility: Investigational Site Number 840007
state: South Dakota
city: Rapid City
country: United States
facility: Investigational Site Number 840027
state: South Dakota
city: Dallas
country: United States
facility: Investigational Site Number 840041
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840029
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840034
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840002
state: Texas
city: Chesapeake
country: United States
facility: Investigational Site Number 840011
state: Virginia
city: Tacoma
country: United States
facility: Investigational Site Number 840023
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840009
state: Wisconsin
city: Corbeil Essonnes
country: France
facility: Investigational Site Number 250002
city: Mantes La Jolie
country: France
facility: Investigational Site Number 250005
city: Montpellier Cedex 5
country: France
facility: Investigational Site Number 250003
city: Vandoeuvre Les Nancy
country: France
facility: Investigational Site Number 250001
city: Berlin
country: Germany
facility: Investigational Site Number 276001
city: Dortmund
country: Germany
facility: Investigational Site Number 276004
city: Hannover
country: Germany
facility: Investigational Site Number 276006
city: Heidelberg
country: Germany
facility: Investigational Site Number 276002
city: Neumünster
country: Germany
facility: Investigational Site Number 276003
city: Pirna
country: Germany
facility: Investigational Site Number 276008
city: Potsdam
country: Germany
facility: Investigational Site Number 276007
city: Sulzbach-Rosenberg
country: Germany
facility: Investigational Site Number 276005
city: Budapest
country: Hungary
facility: Investigational Site Number 348002
city: Budapest
country: Hungary
facility: Investigational Site Number 348005
city: Budapest
country: Hungary
facility: Investigational Site Number 348003
city: Budapest
country: Hungary
facility: Investigational Site Number 348011
city: Budapest
country: Hungary
facility: Investigational Site Number 348010
city: Budapest
country: Hungary
facility: Investigational Site Number 348001
city: Debrecen
country: Hungary
facility: Investigational Site Number 348007
city: Chuo-Ku
country: Japan
facility: Investigational Site Number 392006
city: Higashiosaka-Shi
country: Japan
facility: Investigational Site Number 392003
city: Izumisano-Shi
country: Japan
facility: Investigational Site Number 392004
city: Kamakura-Shi
country: Japan
facility: Investigational Site Number 392005
city: Shinjuku-Ku
country: Japan
facility: Investigational Site Number 392001
city: Yamato-Shi
country: Japan
facility: Investigational Site Number 392002
city: Krakow
country: Poland
facility: Investigational Site Number 616005
city: Poznan
country: Poland
facility: Investigational Site Number 616001
city: Szczecin
country: Poland
facility: Investigational Site Number 616003
city: Warszawa
country: Poland
facility: Investigational Site Number 616002
city: Zabrze
country: Poland
facility: Investigational Site Number 616004
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643003
city: Samara
country: Russian Federation
facility: Investigational Site Number 643006
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643002
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643004
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643001
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643005
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 643007
city: A Coruña
country: Spain
facility: Investigational Site Number 724002
city: Cáceres
country: Spain
facility: Investigational Site Number 724001
city: Lérida
country: Spain
facility: Investigational Site Number 724004
city: Málaga
country: Spain
facility: Investigational Site Number 724005
city: Sabadell
country: Spain
facility: Investigational Site Number 724003
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: 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.