Clinical trial NCT02294474: Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Official title: Six-month, Randomized, Open-label, Parallel-group Comparison of the Insulin Analog SAR342434 to Humalog® in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2014-11-19
Enrollment: 505
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 hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) 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. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c \<7.0% and \<=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose.

To assess safety of SAR342434 and Humalog.

Detailed description: The study will consist of a: up to 2 weeks screening period, 26-week treatment period, and 1-day follow-up period.

The maximum study duration will then be 28 weeks per participant and a 1-day safety follow-up.

Eligibility criteria: Inclusion criteria:

* Participants with T2DM diagnosed for at least 12 months and treated with insulin glargine and Humalog®/Liprolog® or NovoLog®/NovoRapid® (at least 3 times daily, before each meal) in the 6 months prior to the screening visit.
* Signed written informed consent.

Exclusion criteria:

* At screening visit, age under legal age of adulthood.
* HbA1c \<6.5% or \>10.0% at screening.
* Diabetes other than T2DM.
* Pregnancy and lactation.
* Women of childbearing potential not protected by highly effective contraceptive method of birth control.
* Use of insulin pump in the 6 months before screening visit.
* Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
* Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
* Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
* Body mass index (BMI) \>=40kg/m² at screening visit.
* 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% and <=6.5% 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 Glucose (PPG) Excursion From Baseline to Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)
timeFrame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 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: 210 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: 210 days)
Other outcomes:
measure: Change in Daily Insulin Dose From Baseline to Week 26
timeFrame: Baseline, Week 26
Locations:
city: Foley
country: United States
facility: Investigational Site Number 840217
state: Alabama
city: Muscle Shoals
country: United States
facility: Investigational Site Number 840237
state: Alabama
city: Chandler
country: United States
facility: Investigational Site Number 840245
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840219
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840227
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site Number 840212
state: Arkansas
city: El Cajon
country: United States
facility: Investigational Site Number 840241
state: California
city: Fresno
country: United States
facility: Investigational Site Number 840238
state: California
city: Greenbrae
country: United States
facility: Investigational Site Number 840229
state: California
city: Huntington Beach
country: United States
facility: Investigational Site Number 840231
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840247
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840234
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840235
state: California
city: Palm Springs
country: United States
facility: Investigational Site Number 840251
state: California
city: Santa Ana
country: United States
facility: Investigational Site Number 840249
state: California
city: Temecula
country: United States
facility: Investigational Site Number 840223
state: California
city: Tustin
country: United States
facility: Investigational Site Number 840259
state: California
city: Walnut Creek
country: United States
facility: Investigational Site Number 840240
state: California
city: Boynton Beach
country: United States
facility: Investigational Site Number 840214
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840246
state: Florida
city: New Port Richey
country: United States
facility: Investigational Site Number 840226
state: Florida
city: Ocoee
country: United States
facility: Investigational Site Number 840205
state: Florida
city: Palm Harbor
country: United States
facility: Investigational Site Number 840206
state: Florida
city: Port Charlotte
country: United States
facility: Investigational Site Number 840242
state: Florida
city: Lawrenceville
country: United States
facility: Investigational Site Number 840253
state: Georgia
city: Stockbridge
country: United States
facility: Investigational Site Number 840207
state: Georgia
city: Arlington Heights
country: United States
facility: Investigational Site Number 840248
state: Illinois
city: Avon
country: United States
facility: Investigational Site Number 840204
state: Indiana
city: Evansville
country: United States
facility: Investigational Site Number 840257
state: Indiana
city: Des Moines
country: United States
facility: Investigational Site Number 840230
state: Iowa
city: Rockville
country: United States
facility: Investigational Site Number 840239
state: Maryland
city: Troy
country: United States
facility: Investigational Site Number 840236
state: Michigan
city: Lincoln
country: United States
facility: Investigational Site Number 840216
state: Nebraska
city: Las Vegas
country: United States
facility: Investigational Site Number 840220
state: Nevada
city: Las Vegas
country: United States
facility: Investigational Site Number 840233
state: Nevada
city: Linden
country: United States
facility: Investigational Site Number 840224
state: New Jersey
city: Greensboro
country: United States
facility: Investigational Site Number 840232
state: North Carolina
city: Morehead City
country: United States
facility: Investigational Site Number 840211
state: North Carolina
city: Morganton
country: United States
facility: Investigational Site Number 840228
state: North Carolina
city: Fargo
country: United States
facility: Investigational Site Number 840225
state: North Dakota
city: Columbus
country: United States
facility: Investigational Site Number 840221
state: Ohio
city: Dayton
country: United States
facility: Investigational Site Number 840255
state: Ohio
city: Tipton
country: United States
facility: Investigational Site Number 840250
state: Pennsylvania
city: Uniontown
country: United States
facility: Investigational Site Number 840243
state: Pennsylvania
city: Chattanooga
country: United States
facility: Investigational Site Number 840208
state: Tennessee
city: Jackson
country: United States
facility: Investigational Site Number 840215
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840203
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840258
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840201
state: Texas
city: Renton
country: United States
facility: Investigational Site Number 840222
state: Washington
city: Milwaukee
country: United States
facility: Investigational Site Number 840209
state: Wisconsin
city: Caba
country: Argentina
facility: Investigational Site Number 032201
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032206
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032202
city: Ciudad Autonoma De Buenos Aire
country: Argentina
facility: Investigational Site Number 032205
city: Salta
country: Argentina
facility: Investigational Site Number 032203
city: Santiago
country: Chile
facility: Investigational Site Number 152202
city: Santiago
country: Chile
facility: Investigational Site Number 152204
city: Santiago
country: Chile
facility: Investigational Site Number 152201
city: Armenia
country: Colombia
facility: Investigational Site Number 170203
city: Berlin
country: Germany
facility: Investigational Site Number 276201
city: Heidelberg
country: Germany
facility: Investigational Site Number 276204
city: Neumünster
country: Germany
facility: Investigational Site Number 276202
city: Potsdam
country: Germany
facility: Investigational Site Number 276206
city: Stuttgart
country: Germany
facility: Investigational Site Number 276205
city: Sulzbach-Rosenberg
country: Germany
facility: Investigational Site Number 276203
city: Budapest
country: Hungary
facility: Investigational Site Number 348205
city: Budapest
country: Hungary
facility: Investigational Site Number 348202
city: Debrecen
country: Hungary
facility: Investigational Site Number 348204
city: Komárom
country: Hungary
facility: Investigational Site Number 348208
city: Nagykanizsa
country: Hungary
facility: Investigational Site Number 348210
city: Szolnok
country: Hungary
facility: Investigational Site Number 348203
city: Sátoraljaújhely
country: Hungary
facility: Investigational Site Number 348209
city: Bologna
country: Italy
facility: Investigational Site Number 380203
city: Milano
country: Italy
facility: Investigational Site Number 380201
city: Roma
country: Italy
facility: Investigational Site Number 380204
city: Sesto San Giovanni
country: Italy
facility: Investigational Site Number 380202
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410202
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410204
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410205
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number 410201
city: Bacau
country: Romania
facility: Investigational Site Number 642210
city: Bucuresti
country: Romania
facility: Investigational Site Number 642201
city: Bucuresti
country: Romania
facility: Investigational Site Number 642202
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642206
city: Deva
country: Romania
facility: Investigational Site Number 642204
city: Oradea
country: Romania
facility: Investigational Site Number 642205
city: Sibiu
country: Romania
facility: Investigational Site Number 642209
city: Targu Mures
country: Romania
facility: Investigational Site Number 642207
city: Targu Mures
country: Romania
facility: Investigational Site Number 642208
city: Timisoara
country: Romania
facility: Investigational Site Number 642203
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643201
city: Saratov
country: Russian Federation
facility: Investigational Site Number 643205
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643203
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643202
city: St. Petersburg
country: Russian Federation
facility: Investigational Site Number 643204
city: Barcelona
country: Spain
facility: Investigational Site Number 724201
city: Málaga
country: Spain
facility: Investigational Site Number 724203
city: Palma De Mallorca
country: Spain
facility: Investigational Site Number 724202
city: Istanbul
country: Turkey
facility: Investigational Site Number 792201
city: Istanbul
country: Turkey
facility: Investigational Site Number 792202
city: Izmir
country: Turkey
facility: Investigational Site Number 792204
city: Izmir
country: Turkey
facility: Investigational Site Number 792203
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Derwahl KM, Bailey TS, Wernicke-Panten K, Ping L, Pierre S. Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 2 Diabetes, Also Using Insulin Glargine: SORELLA 2 Study. Diabetes Technol Ther. 2018 Jan;20(1):49-58. doi: 10.1089/dia.2017.0281. Epub 2017 Dec 12.