AzTrials
AzTrials

Type 1 Diabetes MellitusPhase 3SORELLA1NCT02273180

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

A Phase 3 study testing SAR342434, Humalog and Insulin glargine HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 89 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
SAR342434, Humalog and Insulin glargine HOE901
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
507 participants
Where
89 sitesin 8 countries
Study dates
Oct 2014to Jul 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

89 sites in 8 countries.

89 sites in 8 countries

United States47 sites

  • Investigational Site Number 840015

    Albuquerque, New Mexico, 87106

  • Investigational Site Number 840054

    Albuquerque, New Mexico, 87109

  • Investigational Site Number 840036

    Atlanta, Georgia, 30318

  • Investigational Site Number 840038

    Baltimore, Maryland, 21237

  • Investigational Site Number 840016

    Bell Gardens, California, 90201

  • Investigational Site Number 840005

    Bradenton, Florida, 34208

  • Investigational Site Number 840030

    Burlington, North Carolina, 27215

  • Investigational Site Number 840011

    Chesapeake, Virginia, 23321

  • Investigational Site Number 840019

    Chicago, Illinois, 60607

  • Investigational Site Number 840033

    Chicago, Illinois, 60612

  • Investigational Site Number 840048

    Chula Vista, California, 91910

  • Investigational Site Number 840046

    Concord, California, 94520

  • Investigational Site Number 840007

    Dakota Dunes, South Dakota, 57049

  • Investigational Site Number 840041

    Dallas, Texas, 75230

  • Investigational Site Number 840029

    Dallas, Texas, 75231

  • Investigational Site Number 840034

    Dallas, Texas, 75246

  • Investigational Site Number 840003

    Denver, Colorado, 80209

  • Investigational Site Number 840037

    Denver, Colorado, 80262

  • Investigational Site Number 840004

    Des Moines, Iowa, 50314

  • Investigational Site Number 840039

    Fresno, California, 93720

  • Investigational Site Number 840018

    Gallipolis, Ohio, 45631

  • Investigational Site Number 840060

    Great Falls, Montana, 59405

  • Investigational Site Number 840051

    Greenville, North Carolina, 27834

  • Investigational Site Number 840002

    Houston, Texas, 77090

  • Investigational Site Number 840020

    Idaho Falls, Idaho, 83404

  • Investigational Site Number 840028

    La Jolla, California, 92037

  • Investigational Site Number 840043

    Marrero, Louisiana, 70072

  • Investigational Site Number 840012

    McHenry, Illinois, 60050

  • Investigational Site Number 840021

    Metairie, Louisiana, 70006

  • Investigational Site Number 840050

    Miami, Florida, 33155

  • Investigational Site Number 840042

    Miami, Florida, 33176

  • Investigational Site Number 840061

    Miami Lakes, Florida, 33014

  • Investigational Site Number 840057

    Miami Lakes, Florida, 33016

  • Investigational Site Number 840009

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840059

    Mineola, New York, 11501

  • Investigational Site Number 840006

    New Port Richey, Florida, 34652

  • Investigational Site Number 840013

    North Miami Beach, Florida, 33162

  • Investigational Site Number 840026

    Omaha, Nebraska, 68114

  • Investigational Site Number 840040

    Omaha, Nebraska, 68131

  • Investigational Site Number 840031

    Port Charlotte, Florida, 33952

  • Investigational Site Number 840027

    Rapid City, South Dakota, 57701

  • Investigational Site Number 840014

    Rockville, Maryland, 20852

  • Investigational Site Number 840045

    Roswell, Georgia, 30076

  • Investigational Site Number 840023

    Tacoma, Washington, 98415-0299

  • Investigational Site Number 840049

    Tucson, Arizona, 85714

  • Investigational Site Number 840022

    Ventura, California, 93003

  • Investigational Site Number 840062

    Wilmington, North Carolina, 28401

Other trials in United States

Germany8 sites

  • Investigational Site Number 276001

    Berlin, 10115

  • Investigational Site Number 276004

    Dortmund, 44137

  • Investigational Site Number 276006

    Hanover, 30159

  • Investigational Site Number 276002

    Heidelberg, 69115

  • Investigational Site Number 276003

    Neumünster, 24534

  • Investigational Site Number 276008

    Pirna, 01796

  • Investigational Site Number 276007

    Potsdam, 14469

  • Investigational Site Number 276005

    Sulzbach-Rosenberg, 92237

Other trials in Germany

Hungary7 sites

  • Investigational Site Number 348002

    Budapest, 1023

  • Investigational Site Number 348005

    Budapest, 1033

  • Investigational Site Number 348003

    Budapest, 1062

  • Investigational Site Number 348011

    Budapest, 1062

  • Investigational Site Number 348010

    Budapest, 1139

  • Investigational Site Number 348001

    Budapest, 1213

  • Investigational Site Number 348007

    Debrecen, 4031

Other trials in Hungary

Russia7 sites

  • Investigational Site Number 643003

    Moscow, 117036

  • Investigational Site Number 643004

    Saint Petersburg, 190068

  • Investigational Site Number 643001

    Saint Petersburg, 194354

  • Investigational Site Number 643005

    Saint Petersburg, 195257

  • Investigational Site Number 643006

    Samara, 443041

  • Investigational Site Number 643002

    Saratov, 410030

  • Investigational Site Number 643007

    Tomsk, 634050

Other trials in Russia

Japan6 sites

  • Investigational Site Number 392006

    Chūōku

  • Investigational Site Number 392003

    Higashiosaka-Shi

  • Investigational Site Number 392004

    Izumisano

  • Investigational Site Number 392005

    Kamakura-Shi

  • Investigational Site Number 392001

    Shinjuku-Ku

  • Investigational Site Number 392002

    Yamato-Shi

Other trials in Japan

Poland5 sites

  • Investigational Site Number 616005

    Krakow, 31-501

  • Investigational Site Number 616001

    Poznan, 60-834

  • Investigational Site Number 616003

    Szczecin, 70-506

  • Investigational Site Number 616002

    Warsaw, 02-507

  • Investigational Site Number 616004

    Zabrze, 41-800

Other trials in Poland

Spain5 sites

  • Investigational Site Number 724002

    A Coruña, 15006

  • Investigational Site Number 724001

    Cáceres, 10003

  • Investigational Site Number 724004

    Lleida, 25198

  • Investigational Site Number 724005

    Málaga, 29010

  • Investigational Site Number 724003

    Sabadell, 08208

Other trials in Spain

France4 sites

  • Investigational Site Number 250002

    Corbeil-Essonnes, 91100

  • Investigational Site Number 250005

    Mantes-la-Jolie, 78200

  • Investigational Site Number 250003

    Montpellier, 34295

  • Investigational Site Number 250001

    Vandœuvre-lès-Nancy, 54511

Other trials in France

About this study

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

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.

Read more

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.

Read the 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
Being tested
SAR342434, Humalog, Insulin glargine HOE901
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR342434Drug

    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.

  • HumalogDrug

    Also called Insulin Lispro

    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 HOE901Drug

    Also called Lantus

    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.

Study groups in NCT02273180
Study groupRoleWhat they receive
SAR342434ExperimentalSAR342434 before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52.
Receives: Drug: SAR342434; Drug: Insulin glargine HOE901
HumalogActive comparatorHumalog before meals intake on top of QD Insulin Glargine, up to Week 52.
Receives: Drug: Humalog; Drug: Insulin glargine HOE901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, Week 26

Secondary outcomes (7)

  1. 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.

    Measured: Week 26

  2. 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.

    Measured: Baseline, Week 26

  3. 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.

    Measured: Baseline, Week 26

  4. 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.

    Measured: Baseline, Week 26

  5. 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.

    Measured: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

  6. Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions

    Percentage of participants with hypersensitivity reactions and injection site reactions were reported.

    Measured: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

  7. 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).

    Measured: First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 400 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionDec 2015
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
507 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273180
Sponsor's protocol ID
EFC12619
Other IDs
2013-002945-12, U1111-1131-5038
Acronym
SORELLA1
Status last verified
Dec 2017
First submitted
21 Oct 2014
Last updated
18 Jan 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 28722480

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SAR342434, Humalog and Insulin glargine HOE901 in people with Type 1 Diabetes Mellitus, run by Sanofi at 89 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Germany, Hungary, Russia, Japan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02273180, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in