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Type 2 Diabetes MellitusPhase 3SORELLA2NCT02294474

Comparison of SAR342434 to Humalog as the Rapid Acting Insulin in Adult Patients With Type 2 Diabetes Mellitus Also Using Insulin Glargine

A Phase 3 study testing SAR342434, Humalog and insulin glargine HOE901 in people with Type 2 Diabetes Mellitus, run by Sanofi at 103 sites in 12 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 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
505 participants
Where
103 sitesin 12 countries
Study dates
Jan 2015to Feb 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 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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

Trial locations and contacts

103 sites in 12 countries.

103 sites in 12 countries

United States51 sites

  • Investigational Site Number 840248

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840203

    Austin, Texas, 78731

  • Investigational Site Number 840204

    Avon, Indiana, 46123

  • Investigational Site Number 840214

    Boynton Beach, Florida, 33472

  • Investigational Site Number 840245

    Chandler, Arizona

  • Investigational Site Number 840208

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840221

    Columbus, Ohio, 43201

  • Investigational Site Number 840258

    Dallas, Texas, 75231

  • Investigational Site Number 840201

    Dallas, Texas, 75246

  • Investigational Site Number 840255

    Dayton, Ohio, 45439

  • Investigational Site Number 840230

    Des Moines, Iowa, 50314

  • Investigational Site Number 840241

    El Cajon, California, 92020

  • Investigational Site Number 840257

    Evansville, Indiana, 47714

  • Investigational Site Number 840225

    Fargo, North Dakota, 58103

  • Investigational Site Number 840217

    Foley, Alabama, 36535

  • Investigational Site Number 840238

    Fresno, California, 93720

  • Investigational Site Number 840229

    Greenbrae, California, 94904

  • Investigational Site Number 840232

    Greensboro, North Carolina, 27408

  • Investigational Site Number 840231

    Huntington Beach, California, 92648

  • Investigational Site Number 840215

    Jackson, Tennessee, 38305

  • Investigational Site Number 840220

    Las Vegas, Nevada, 89119

  • Investigational Site Number 840233

    Las Vegas, Nevada, 89148

  • Investigational Site Number 840253

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 840216

    Lincoln, Nebraska, 68521

  • Investigational Site Number 840224

    Linden, New Jersey

  • Investigational Site Number 840212

    Little Rock, Arkansas, 72205

  • Investigational Site Number 840247

    Long Beach, California, 90807

  • Investigational Site Number 840234

    Los Angeles, California, 90057

  • Investigational Site Number 840246

    Miami, Florida, 33176

  • Investigational Site Number 840209

    Milwaukee, Wisconsin, 53209-0996

  • Investigational Site Number 840211

    Morehead City, North Carolina, 28557

  • Investigational Site Number 840228

    Morganton, North Carolina, 28655

  • Investigational Site Number 840237

    Muscle Shoals, Alabama, 35661

  • Investigational Site Number 840226

    New Port Richey, Florida, 34652

  • Investigational Site Number 840235

    Northridge, California, 91325

  • Investigational Site Number 840205

    Ocoee, Florida, 34761

  • Investigational Site Number 840206

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840251

    Palm Springs, California, 92262

  • Investigational Site Number 840219

    Phoenix, Arizona, 85028

  • Investigational Site Number 840227

    Phoenix, Arizona, 85050

  • Investigational Site Number 840242

    Port Charlotte, Florida, 33952

  • Investigational Site Number 840222

    Renton, Washington, 98055

  • Investigational Site Number 840239

    Rockville, Maryland, 20852

  • Investigational Site Number 840249

    Santa Ana, California, 92704

  • Investigational Site Number 840207

    Stockbridge, Georgia, 30281

  • Investigational Site Number 840223

    Temecula, California, 92591

  • Investigational Site Number 840250

    Tipton, Pennsylvania, 16684

  • Investigational Site Number 840236

    Troy, Michigan, 48085

  • Investigational Site Number 840259

    Tustin, California, 92780

  • Investigational Site Number 840243

    Uniontown, Pennsylvania, 15401

  • Investigational Site Number 840240

    Walnut Creek, California, 94598

Other trials in United States

Romania10 sites

  • Investigational Site Number 642210

    Bacau, 600154

  • Investigational Site Number 642201

    Bucharest, 020042

  • Investigational Site Number 642202

    Bucharest, 020042

  • Investigational Site Number 642206

    Cluj-Napoca, 400006

  • Investigational Site Number 642204

    Deva, 330084

  • Investigational Site Number 642205

    Oradea, 410159

  • Investigational Site Number 642209

    Sibiu, 550371

  • Investigational Site Number 642207

    Târgu Mureş, 540142

  • Investigational Site Number 642208

    Târgu Mureş, 540142

  • Investigational Site Number 642203

    Timișoara, 300456

Other trials in Romania

Hungary7 sites

  • Investigational Site Number 348205

    Budapest, 1036

  • Investigational Site Number 348202

    Budapest, 1135

  • Investigational Site Number 348204

    Debrecen, 4032

  • Investigational Site Number 348208

    Komárom, 2900

  • Investigational Site Number 348210

    Nagykanizsa, 8800

  • Investigational Site Number 348209

    Sátoraljaújhely, 3980

  • Investigational Site Number 348203

    Szolnok, 5004

Other trials in Hungary

Germany6 sites

  • Investigational Site Number 276201

    Berlin, 10115

  • Investigational Site Number 276204

    Heidelberg, 69115

  • Investigational Site Number 276202

    Neumünster, 24534

  • Investigational Site Number 276206

    Potsdam, 14469

  • Investigational Site Number 276205

    Stuttgart, 70378

  • Investigational Site Number 276203

    Sulzbach-Rosenberg, 92237

Other trials in Germany

Argentina5 sites

  • Investigational Site Number 032201

    Caba, C1425AGC

  • Investigational Site Number 032206

    Capital Federal, C1056ABJ

  • Investigational Site Number 032202

    Capital Federal, C1179AAB

  • Investigational Site Number 032205

    Ciudad Autonoma de Buenos Aire

  • Investigational Site Number 032203

    Salta, 4400

Other trials in Argentina

Russia5 sites

  • Investigational Site Number 643201

    Saint Petersburg, 190013

  • Investigational Site Number 643203

    Saint Petersburg, 194354

  • Investigational Site Number 643204

    Saint Petersburg, 194358

  • Investigational Site Number 643202

    Saint Petersburg, 195257

  • Investigational Site Number 643205

    Saratov, 410030

Other trials in Russia

Italy4 sites

  • Investigational Site Number 380203

    Bologna, 40138

  • Investigational Site Number 380201

    Milan, 20132

  • Investigational Site Number 380204

    Roma, 00133

  • Investigational Site Number 380202

    Sesto San Giovanni, 20099

Other trials in Italy

South Korea4 sites

  • Investigational Site Number 410202

    Seoul, 110-746

  • Investigational Site Number 410204

    Seoul, 130-872

  • Investigational Site Number 410205

    Seoul, 139-872

  • Investigational Site Number 410201

    Wŏnju, 220-701

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Investigational Site Number 792201

    Istanbul, 34303

  • Investigational Site Number 792202

    Istanbul, 34890

  • Investigational Site Number 792204

    Izmir, 35100

  • Investigational Site Number 792203

    Izmir, 35340

Other trials in Turkey (Türkiye)

Chile3 sites

  • Investigational Site Number 152202

    Santiago, 7500347

  • Investigational Site Number 152204

    Santiago, 7500347

  • Investigational Site Number 152201

    Santiago, 7500710

Other trials in Chile

Spain3 sites

  • Investigational Site Number 724201

    Barcelona, 08035

  • Investigational Site Number 724203

    Málaga, 29010

  • Investigational Site Number 724202

    Palma de Mallorca, 07010

Other trials in Spain

Colombia1 site

  • Investigational Site Number 170203

    Armenia, 630004

Other trials in Colombia

About this study

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

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.

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. 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.

Read the 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.

Being tested
SAR342434, Humalog, insulin glargine HOE901
Medical subject headings
Diabetes Mellitus, Type 2

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 subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial 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 SC injection, immediately (within 5-10 minutes) before meals 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 hypoglycemia.

  • 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 NCT02294474
Study groupRoleWhat they receive
SAR342434ExperimentalSAR342434 100 Unit/mL (U/mL) before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.
Receives: Drug: SAR342434; Drug: insulin glargine HOE901
HumalogActive comparatorHumalog 100 U/mL before meals intake on top of QD Insulin Glargine, up to Week 26.
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 6-month period and adequate contrasts at Week 26.

    Measured: Baseline, Week 26

Secondary outcomes (7)

  1. Percentage of Participants With HbA1c <7.0% and <=6.5% 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 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

    The 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. 7-point SMPGs were performed at least two times in a week before baseline, before visit Week 12 and before visit Week 26. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the 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 6-month period and adequate contrasts at Week 26.

    Measured: Baseline, Week 26

  4. Change in Post Prandial 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 postprandial glucose (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 6-month period and adequate contrasts at Week 26.

    Measured: Baseline, Week 26

  5. Percentage of Participants With Hypoglycemia (Any Hypoglycemia, Documented Symptomatic Hypoglycemia and Severe Hypoglycemia)

    Percentage of participants with at least one treatment emergent hypoglycemia reported at any time of the day 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: 210 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: 210 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 participants 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 participants 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: 210 days)

Timeline

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

  1. First posted19 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 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
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02294474
Sponsor's protocol ID
EFC13403
Other IDs
2014-002844-42, U1111-1156-4296, 2014
Acronym
SORELLA2
Status last verified
Dec 2017
First submitted
14 Nov 2014
Last updated
18 Jan 2018
Data monitoring committee
No

Publications

  • 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.

    PubMed 29232162

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 2 Diabetes Mellitus, run by Sanofi at 103 sites in 12 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 13 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 103 sites in United States, Romania, Hungary, Germany, Argentina and 7 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 NCT02294474, 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.

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