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Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine (SORELLA1)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
SAR342434
Humalog
Insulin glargine HOE901
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840049
  • Investigational Site Number 840016
  • Investigational Site Number 840048
  • Investigational Site Number 840046
  • Investigational Site Number 840039
  • Investigational Site Number 840028
  • Investigational Site Number 840022
  • Investigational Site Number 840003
  • Investigational Site Number 840037
  • Investigational Site Number 840005
  • Investigational Site Number 840061
  • Investigational Site Number 840057
  • Investigational Site Number 840050
  • Investigational Site Number 840042
  • Investigational Site Number 840006
  • Investigational Site Number 840013
  • Investigational Site Number 840031
  • Investigational Site Number 840036
  • Investigational Site Number 840045
  • Investigational Site Number 840020
  • Investigational Site Number 840019
  • Investigational Site Number 840033
  • Investigational Site Number 840012
  • Investigational Site Number 840004
  • Investigational Site Number 840043
  • Investigational Site Number 840021
  • Investigational Site Number 840038
  • Investigational Site Number 840014
  • Investigational Site Number 840060
  • Investigational Site Number 840026
  • Investigational Site Number 840040
  • Investigational Site Number 840015
  • Investigational Site Number 840054
  • Investigational Site Number 840059
  • Investigational Site Number 840030
  • Investigational Site Number 840051
  • Investigational Site Number 840062
  • Investigational Site Number 840018
  • Investigational Site Number 840007
  • Investigational Site Number 840027
  • Investigational Site Number 840041
  • Investigational Site Number 840029
  • Investigational Site Number 840034
  • Investigational Site Number 840002
  • Investigational Site Number 840011
  • Investigational Site Number 840023
  • Investigational Site Number 840009
  • Investigational Site Number 250002
  • Investigational Site Number 250005
  • Investigational Site Number 250003
  • Investigational Site Number 250001
  • Investigational Site Number 276001
  • Investigational Site Number 276004
  • Investigational Site Number 276006
  • Investigational Site Number 276002
  • Investigational Site Number 276003
  • Investigational Site Number 276008
  • Investigational Site Number 276007
  • Investigational Site Number 276005
  • Investigational Site Number 348002
  • Investigational Site Number 348005
  • Investigational Site Number 348003
  • Investigational Site Number 348011
  • Investigational Site Number 348010
  • Investigational Site Number 348001
  • Investigational Site Number 348007
  • Investigational Site Number 392006
  • Investigational Site Number 392003
  • Investigational Site Number 392004
  • Investigational Site Number 392005
  • Investigational Site Number 392001
  • Investigational Site Number 392002
  • Investigational Site Number 616005
  • Investigational Site Number 616001
  • Investigational Site Number 616003
  • Investigational Site Number 616002
  • Investigational Site Number 616004
  • Investigational Site Number 643003
  • Investigational Site Number 643006
  • Investigational Site Number 643002
  • Investigational Site Number 643004
  • Investigational Site Number 643001
  • Investigational Site Number 643005
  • Investigational Site Number 643007
  • Investigational Site Number 724002
  • Investigational Site Number 724001
  • Investigational Site Number 724004
  • Investigational Site Number 724005
  • Investigational Site Number 724003

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SAR342434

Humalog

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With HbA1c <7.0% at Week 26
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26.
Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.
Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.
Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year
Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Percentage of participants with hypersensitivity reactions and injection site reactions were reported.
Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)
Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).

Full Information

First Posted
October 21, 2014
Last Updated
December 20, 2017
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02273180
Brief Title
Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
Acronym
SORELLA1
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

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
507 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAR342434
Arm Type
Experimental
Arm Description
SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
Arm Title
Humalog
Arm Type
Active Comparator
Arm Description
Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
Intervention Type
Drug
Intervention Name(s)
SAR342434
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Humalog
Other Intervention Name(s)
Insulin Lispro
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Insulin glargine HOE901
Other Intervention Name(s)
Lantus
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline to Week 26
Description
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.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Percentage of Participants With HbA1c <7.0% at Week 26
Description
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Time Frame
Week 26
Title
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Description
Change in FPG was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM approach to account for missing data, using all post-baseline FPG data available during the main 6-month period and adequate contrasts at Week 26.
Time Frame
Baseline, Week 26
Title
Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
Description
Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in week before a visit. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.
Time Frame
Baseline, Week 26
Title
Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
Description
Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as average across the profiles performed in the week before the visit. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Adjusted least squares means and standard errors were obtained from a MMRM to account for missing data, using all post-baseline data available during the main 6-month period and adequate contrasts at Week 26.
Time Frame
Baseline, Week 26
Title
Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year
Description
Number of treatment-emergent hypoglycemia events per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of <=70 mg/dL (3.9 mmol/L). Hypoglycemic episodes with plasma glucose of 54 mg/dL (<3.0 mmol/L) were also analyzed.
Time Frame
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Title
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Description
Percentage of participants with hypersensitivity reactions and injection site reactions were reported.
Time Frame
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Title
Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)
Description
Participants with treatment-emergent AIA (incidence) were reported (as participants with treatment-boosted or treatment-induced AIAs). Participants with treatment-induced AIAs were those who developed AIA following IMP administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing baseline sample). Participants with treatment-boosted AIAs were those with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to baseline value at any time during on-treatment period, in those participants with pre-existing AIA).
Time Frame
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Other Pre-specified Outcome Measures:
Title
Change in Daily Insulin Dose From Baseline to Week 26 and Week 52
Description
Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively.
Time Frame
Baseline, Week 26, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 840049
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85714
Country
United States
Facility Name
Investigational Site Number 840016
City
Bell Gardens
State/Province
California
ZIP/Postal Code
90201
Country
United States
Facility Name
Investigational Site Number 840048
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Investigational Site Number 840046
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Investigational Site Number 840039
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Investigational Site Number 840028
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Investigational Site Number 840022
City
Ventura
State/Province
California
ZIP/Postal Code
93003
Country
United States
Facility Name
Investigational Site Number 840003
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Investigational Site Number 840037
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Investigational Site Number 840005
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Investigational Site Number 840061
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Investigational Site Number 840057
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Investigational Site Number 840050
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Investigational Site Number 840042
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Investigational Site Number 840006
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Investigational Site Number 840013
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33162
Country
United States
Facility Name
Investigational Site Number 840031
City
Port Charlotte
State/Province
Florida
ZIP/Postal Code
33952
Country
United States
Facility Name
Investigational Site Number 840036
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Facility Name
Investigational Site Number 840045
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigational Site Number 840020
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Investigational Site Number 840019
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Investigational Site Number 840033
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Investigational Site Number 840012
City
McHenry
State/Province
Illinois
ZIP/Postal Code
60050
Country
United States
Facility Name
Investigational Site Number 840004
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Investigational Site Number 840043
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Investigational Site Number 840021
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Investigational Site Number 840038
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Investigational Site Number 840014
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Investigational Site Number 840060
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Investigational Site Number 840026
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Investigational Site Number 840040
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Investigational Site Number 840015
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Investigational Site Number 840054
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Investigational Site Number 840059
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Investigational Site Number 840030
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Investigational Site Number 840051
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Investigational Site Number 840062
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Investigational Site Number 840018
City
Gallipolis
State/Province
Ohio
ZIP/Postal Code
45631
Country
United States
Facility Name
Investigational Site Number 840007
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
Investigational Site Number 840027
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site Number 840041
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Investigational Site Number 840029
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigational Site Number 840034
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Investigational Site Number 840002
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Investigational Site Number 840011
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Investigational Site Number 840023
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98415-0299
Country
United States
Facility Name
Investigational Site Number 840009
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
Investigational Site Number 250002
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
Investigational Site Number 250005
City
Mantes La Jolie
ZIP/Postal Code
78200
Country
France
Facility Name
Investigational Site Number 250003
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
Investigational Site Number 250001
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Investigational Site Number 276001
City
Berlin
ZIP/Postal Code
10115
Country
Germany
Facility Name
Investigational Site Number 276004
City
Dortmund
ZIP/Postal Code
44137
Country
Germany
Facility Name
Investigational Site Number 276006
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Investigational Site Number 276002
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Investigational Site Number 276003
City
Neumünster
ZIP/Postal Code
24534
Country
Germany
Facility Name
Investigational Site Number 276008
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Investigational Site Number 276007
City
Potsdam
ZIP/Postal Code
14469
Country
Germany
Facility Name
Investigational Site Number 276005
City
Sulzbach-Rosenberg
ZIP/Postal Code
92237
Country
Germany
Facility Name
Investigational Site Number 348002
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Investigational Site Number 348005
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Investigational Site Number 348003
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Investigational Site Number 348011
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Investigational Site Number 348010
City
Budapest
ZIP/Postal Code
1139
Country
Hungary
Facility Name
Investigational Site Number 348001
City
Budapest
ZIP/Postal Code
1213
Country
Hungary
Facility Name
Investigational Site Number 348007
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Facility Name
Investigational Site Number 392006
City
Chuo-Ku
Country
Japan
Facility Name
Investigational Site Number 392003
City
Higashiosaka-Shi
Country
Japan
Facility Name
Investigational Site Number 392004
City
Izumisano-Shi
Country
Japan
Facility Name
Investigational Site Number 392005
City
Kamakura-Shi
Country
Japan
Facility Name
Investigational Site Number 392001
City
Shinjuku-Ku
Country
Japan
Facility Name
Investigational Site Number 392002
City
Yamato-Shi
Country
Japan
Facility Name
Investigational Site Number 616005
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Investigational Site Number 616001
City
Poznan
ZIP/Postal Code
60-834
Country
Poland
Facility Name
Investigational Site Number 616003
City
Szczecin
ZIP/Postal Code
70-506
Country
Poland
Facility Name
Investigational Site Number 616002
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Investigational Site Number 616004
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Investigational Site Number 643003
City
Moscow
ZIP/Postal Code
117036
Country
Russian Federation
Facility Name
Investigational Site Number 643006
City
Samara
ZIP/Postal Code
443041
Country
Russian Federation
Facility Name
Investigational Site Number 643002
City
Saratov
ZIP/Postal Code
410030
Country
Russian Federation
Facility Name
Investigational Site Number 643004
City
St-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
Investigational Site Number 643001
City
St-Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
Investigational Site Number 643005
City
St-Petersburg
ZIP/Postal Code
195257
Country
Russian Federation
Facility Name
Investigational Site Number 643007
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Investigational Site Number 724002
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Investigational Site Number 724001
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
Investigational Site Number 724004
City
Lérida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Investigational Site Number 724005
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Investigational Site Number 724003
City
Sabadell
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
28722480
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. Erratum In: Diabetes Technol Ther. 2017 Dec;19(12):753.
Results Reference
background

Learn more about this trial

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

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