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

December 20, 2017 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

507

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil Essonnes, France, 91100
        • Investigational Site Number 250002
      • Mantes La Jolie, France, 78200
        • Investigational Site Number 250005
      • Montpellier Cedex 5, France, 34295
        • Investigational Site Number 250003
      • Vandoeuvre Les Nancy, France, 54511
        • Investigational Site Number 250001
  • Germany
      • Berlin, Germany, 10115
        • Investigational Site Number 276001
      • Dortmund, Germany, 44137
        • Investigational Site Number 276004
      • Hannover, Germany, 30159
        • Investigational Site Number 276006
      • Heidelberg, Germany, 69115
        • Investigational Site Number 276002
      • Neumünster, Germany, 24534
        • Investigational Site Number 276003
      • Pirna, Germany, 01796
        • Investigational Site Number 276008
      • Potsdam, Germany, 14469
        • Investigational Site Number 276007
      • Sulzbach-Rosenberg, Germany, 92237
        • Investigational Site Number 276005
  • Hungary
      • Budapest, Hungary, 1023
        • Investigational Site Number 348002
      • Budapest, Hungary, 1033
        • Investigational Site Number 348005
      • Budapest, Hungary, 1062
        • Investigational Site Number 348003
      • Budapest, Hungary, 1062
        • Investigational Site Number 348011
      • Budapest, Hungary, 1139
        • Investigational Site Number 348010
      • Budapest, Hungary, 1213
        • Investigational Site Number 348001
      • Debrecen, Hungary, 4031
        • Investigational Site Number 348007
  • Japan
      • Chuo-Ku, Japan
        • Investigational Site Number 392006
      • Higashiosaka-Shi, Japan
        • Investigational Site Number 392003
      • Izumisano-Shi, Japan
        • Investigational Site Number 392004
      • Kamakura-Shi, Japan
        • Investigational Site Number 392005
      • Shinjuku-Ku, Japan
        • Investigational Site Number 392001
      • Yamato-Shi, Japan
        • Investigational Site Number 392002
  • Poland
      • Krakow, Poland, 31-501
        • Investigational Site Number 616005
      • Poznan, Poland, 60-834
        • Investigational Site Number 616001
      • Szczecin, Poland, 70-506
        • Investigational Site Number 616003
      • Warszawa, Poland, 02-507
        • Investigational Site Number 616002
      • Zabrze, Poland, 41-800
        • Investigational Site Number 616004
  • Russian Federation
      • Moscow, Russian Federation, 117036
        • Investigational Site Number 643003
      • Samara, Russian Federation, 443041
        • Investigational Site Number 643006
      • Saratov, Russian Federation, 410030
        • Investigational Site Number 643002
      • St-Petersburg, Russian Federation, 190068
        • Investigational Site Number 643004
      • St-Petersburg, Russian Federation, 194354
        • Investigational Site Number 643001
      • St-Petersburg, Russian Federation, 195257
        • Investigational Site Number 643005
      • Tomsk, Russian Federation, 634050
        • Investigational Site Number 643007
  • Spain
      • A Coruña, Spain, 15006
        • Investigational Site Number 724002
      • Cáceres, Spain, 10003
        • Investigational Site Number 724001
      • Lérida, Spain, 25198
        • Investigational Site Number 724004
      • Málaga, Spain, 29010
        • Investigational Site Number 724005
      • Sabadell, Spain, 08208
        • Investigational Site Number 724003
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85714
        • Investigational Site Number 840049
    • California
      • Bell Gardens, California, United States, 90201
        • Investigational Site Number 840016
      • Chula Vista, California, United States, 91910
        • Investigational Site Number 840048
      • Concord, California, United States, 94520
        • Investigational Site Number 840046
      • Fresno, California, United States, 93720
        • Investigational Site Number 840039
      • La Jolla, California, United States, 92037
        • Investigational Site Number 840028
      • Ventura, California, United States, 93003
        • Investigational Site Number 840022
    • Colorado
      • Denver, Colorado, United States, 80209
        • Investigational Site Number 840003
      • Denver, Colorado, United States, 80262
        • Investigational Site Number 840037
    • Florida
      • Bradenton, Florida, United States, 34208
        • Investigational Site Number 840005
      • Miami, Florida, United States, 33155
        • Investigational Site Number 840050
      • Miami, Florida, United States, 33176
        • Investigational Site Number 840042
      • Miami Lakes, Florida, United States, 33014
        • Investigational Site Number 840061
      • Miami Lakes, Florida, United States, 33016
        • Investigational Site Number 840057
      • New Port Richey, Florida, United States, 34652
        • Investigational Site Number 840006
      • North Miami Beach, Florida, United States, 33162
        • Investigational Site Number 840013
      • Port Charlotte, Florida, United States, 33952
        • Investigational Site Number 840031
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Investigational Site Number 840036
      • Roswell, Georgia, United States, 30076
        • Investigational Site Number 840045
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Investigational Site Number 840020
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Investigational Site Number 840019
      • Chicago, Illinois, United States, 60612
        • Investigational Site Number 840033
      • McHenry, Illinois, United States, 60050
        • Investigational Site Number 840012
    • Iowa
      • Des Moines, Iowa, United States, 50314
        • Investigational Site Number 840004
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Investigational Site Number 840043
      • Metairie, Louisiana, United States, 70006
        • Investigational Site Number 840021
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Investigational Site Number 840038
      • Rockville, Maryland, United States, 20852
        • Investigational Site Number 840014
    • Montana
      • Great Falls, Montana, United States, 59405
        • Investigational Site Number 840060
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Investigational Site Number 840026
      • Omaha, Nebraska, United States, 68131
        • Investigational Site Number 840040
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Investigational Site Number 840015
      • Albuquerque, New Mexico, United States, 87109
        • Investigational Site Number 840054
    • New York
      • Mineola, New York, United States, 11501
        • Investigational Site Number 840059
    • North Carolina
      • Burlington, North Carolina, United States, 27215
        • Investigational Site Number 840030
      • Greenville, North Carolina, United States, 27834
        • Investigational Site Number 840051
      • Wilmington, North Carolina, United States, 28401
        • Investigational Site Number 840062
    • Ohio
      • Gallipolis, Ohio, United States, 45631
        • Investigational Site Number 840018
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Investigational Site Number 840007
      • Rapid City, South Dakota, United States, 57701
        • Investigational Site Number 840027
    • Texas
      • Dallas, Texas, United States, 75230
        • Investigational Site Number 840041
      • Dallas, Texas, United States, 75231
        • Investigational Site Number 840029
      • Dallas, Texas, United States, 75246
        • Investigational Site Number 840034
      • Houston, Texas, United States, 77090
        • Investigational Site Number 840002
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Investigational Site Number 840011
    • Washington
      • Tacoma, Washington, United States, 98415-0299
        • Investigational Site Number 840023
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209-0996
        • Investigational Site Number 840009

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAR342434
SAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
Drug: 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.
Drug: 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 Names:
  • Lantus
Active Comparator: Humalog
Humalog before meals intake on top of QD Insulin Glargine, up to Week 52.
Drug: 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 Names:
  • Lantus
Drug: 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.
Other Names:
  • Insulin Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline to Week 26
Time Frame: Baseline, 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With HbA1c <7.0% at Week 26
Time Frame: Week 26
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Week 26
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Change in Post Prandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
Time Frame: Baseline, 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.
Baseline, Week 26
Number of Hypoglycemia Events (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia) Per Participant-Year
Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
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.
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Percentage of participants with hypersensitivity reactions and injection site reactions were reported.
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
Percentage of Participants With Treatment Emergent Anti-insulin Antibodies (AIAs)
Time Frame: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)
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).
First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daily Insulin Dose From Baseline to Week 26 and Week 52
Time Frame: Baseline, Week 26, Week 52
Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Week 26 and Week 52 values respectively.
Baseline, Week 26, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (Estimate)

October 23, 2014

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

December 20, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFC12619
  • 2013-002945-12 (EudraCT Number)
  • U1111-1131-5038 (Other Identifier: UTN)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 1 Diabetes Mellitus

Clinical Trials on SAR342434

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe