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

NCT02294474 | Completed Phase 3 Results

• 3 other identifiers: EFC134032014-002844-42U1111-1156-4296
• Study Type: interventional
• Target: 505
• Locations: 12 countries
• Sites: 103

Brief Summary

Primary Objective: To demonstrate non-inferiority of SAR342434 versus Humalog in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 2 diabetes mellitus (T2DM) also using insulin glargine. Secondary Objectives: To assess the immunogenicity of SAR342434 and Humalog in terms of positive/negative status and antibody titers at baseline and during the course of the study; To assess the relationship of anti-insulin antibodies with efficacy and safety. To assess the efficacy of SAR342434 and Humalog on: proportion of participants reaching target HbA1c \<7.0% and \<=6.5%, fasting plasma glucose (FPG) and self-measured plasma glucose (SMPG) profiles, and insulin dose. To assess safety of SAR342434 and Humalog.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

  Baseline, Week 26

Secondary Outcomes (7)

• Percentage of Participants With HbA1c <7.0% and <=6.5% at Week 26

  Week 26

• Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26

  Baseline, Week 26

• Change in Mean 24-Hour Plasma Glucose Concentration From Baseline to Week 26

  Baseline, Week 26

• Change in Post Prandial Glucose (PPG) Excursion From Baseline to Week 26

  Baseline, Week 26

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

  First dose of study drug up to 1 day after the last dose administration (maximum treatment exposure: 210 days)

Other Outcomes (1)

• Change in Daily Insulin Dose From Baseline to Week 26

  Baseline, Week 26

Study Arms (2)

SAR342434

EXPERIMENTAL

SAR342434 100 Unit/mL (U/mL) before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26.

Drug: SAR342434; Drug: insulin glargine HOE901

Humalog

ACTIVE COMPARATOR

Humalog 100 U/mL before meals intake on top of QD Insulin Glargine, up to Week 26.

Drug: Humalog; Drug: insulin glargine HOE901

Interventions

SAR342434 DRUG

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.

SAR342434

Humalog DRUG

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.

Also known as: Insulin Lispro

Humalog

insulin glargine HOE901 DRUG

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.

Also known as: Lantus®

Humalog; SAR342434

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• At screening visit, age under legal age of adulthood.
• HbA1c \<6.5% or \>10.0% at screening.
• Diabetes other than T2DM.
• Pregnancy and lactation.
• Women of childbearing potential not protected by highly effective contraceptive method of birth control.
• Use of insulin pump in the 6 months before screening visit.
• Use of insulin other than insulin glargine and Humalog or NovoLog/NovoRapid in the 6 months prior to screening visit. Liprolog® is an European Union (EU) approved insulin lispro and is allowed in those countries where it is marketed.
• Use of Humalog/Liprolog or Novolog/NovoRapid less than 3 times daily, before each meal.
• Use of non-injectable peptides (eg, Glucagon-like peptide-1 (GLP-1) receptor-agonists or other peptides) in the 6 months prior to screening visit.
• Body mass index (BMI) \>=40kg/m² at screening visit.
• Hospitalization for diabetic ketoacidosis in the last 6 months before screening visit.
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment, or injectable drugs) during the study period.
• The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial

Sponsors & Collaborators

• Sanofi: lead

Study Sites (103)

Investigational Site Number 840217

Foley, Alabama, 36535, United States

Location

Investigational Site Number 840237

Muscle Shoals, Alabama, 35661, United States

Location

Investigational Site Number 840245

Chandler, Arizona, United States

Location

Investigational Site Number 840219

Phoenix, Arizona, 85028, United States

Location

Investigational Site Number 840227

Phoenix, Arizona, 85050, United States

Location

Investigational Site Number 840212

Little Rock, Arkansas, 72205, United States

Location

Investigational Site Number 840241

El Cajon, California, 92020, United States

Location

Investigational Site Number 840238

Fresno, California, 93720, United States

Location

Investigational Site Number 840229

Greenbrae, California, 94904, United States

Location

Investigational Site Number 840231

Huntington Beach, California, 92648, United States

Location

Investigational Site Number 840247

Long Beach, California, 90807, United States

Location

Investigational Site Number 840234

Los Angeles, California, 90057, United States

Location

Investigational Site Number 840235

Northridge, California, 91325, United States

Location

Investigational Site Number 840251

Palm Springs, California, 92262, United States

Location

Investigational Site Number 840249

Santa Ana, California, 92704, United States

Location

Investigational Site Number 840223

Temecula, California, 92591, United States

Location

Investigational Site Number 840259

Tustin, California, 92780, United States

Location

Investigational Site Number 840240

Walnut Creek, California, 94598, United States

Location

Investigational Site Number 840214

Boynton Beach, Florida, 33472, United States

Location

Investigational Site Number 840246

Miami, Florida, 33176, United States

Location

Investigational Site Number 840226

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840205

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 840206

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840242

Port Charlotte, Florida, 33952, United States

Location

Investigational Site Number 840253

Lawrenceville, Georgia, 30046, United States

Location

Investigational Site Number 840207

Stockbridge, Georgia, 30281, United States

Location

Investigational Site Number 840248

Arlington Heights, Illinois, 60005, United States

Location

Investigational Site Number 840204

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840257

Evansville, Indiana, 47714, United States

Location

Investigational Site Number 840230

Des Moines, Iowa, 50314, United States

Location

Investigational Site Number 840239

Rockville, Maryland, 20852, United States

Location

Investigational Site Number 840236

Troy, Michigan, 48085, United States

Location

Investigational Site Number 840216

Lincoln, Nebraska, 68521, United States

Location

Investigational Site Number 840220

Las Vegas, Nevada, 89119, United States

Location

Investigational Site Number 840233

Las Vegas, Nevada, 89148, United States

Location

Investigational Site Number 840224

Linden, New Jersey, United States

Location

Investigational Site Number 840232

Greensboro, North Carolina, 27408, United States

Location

Investigational Site Number 840211

Morehead City, North Carolina, 28557, United States

Location

Investigational Site Number 840228

Morganton, North Carolina, 28655, United States

Location

Investigational Site Number 840225

Fargo, North Dakota, 58103, United States

Location

Investigational Site Number 840221

Columbus, Ohio, 43201, United States

Location

Investigational Site Number 840255

Dayton, Ohio, 45439, United States

Location

Investigational Site Number 840250

Tipton, Pennsylvania, 16684, United States

Location

Investigational Site Number 840243

Uniontown, Pennsylvania, 15401, United States

Location

Investigational Site Number 840208

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 840215

Jackson, Tennessee, 38305, United States

Location

Investigational Site Number 840203

Austin, Texas, 78731, United States

Location

Investigational Site Number 840258

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840201

Dallas, Texas, 75246, United States

Location

Investigational Site Number 840222

Renton, Washington, 98055, United States

Location

Investigational Site Number 840209

Milwaukee, Wisconsin, 53209-0996, United States

Location

Investigational Site Number 032201

Caba, C1425AGC, Argentina

Location

Investigational Site Number 032206

Capital Federal, C1056ABJ, Argentina

Location

Investigational Site Number 032202

Capital Federal, C1179AAB, Argentina

Location

Investigational Site Number 032205

Ciudad Autonoma de Buenos Aire, Argentina

Location

Investigational Site Number 032203

Salta, 4400, Argentina

Location

Investigational Site Number 152202

Santiago, 7500347, Chile

Location

Investigational Site Number 152204

Santiago, 7500347, Chile

Location

Investigational Site Number 152201

Santiago, 7500710, Chile

Location

Investigational Site Number 170203

Armenia, 630004, Colombia

Location

Investigational Site Number 276201

Berlin, 10115, Germany

Location

Investigational Site Number 276204

Heidelberg, 69115, Germany

Location

Investigational Site Number 276202

Neumünster, 24534, Germany

Location

Investigational Site Number 276206

Potsdam, 14469, Germany

Location

Investigational Site Number 276205

Stuttgart, 70378, Germany

Location

Investigational Site Number 276203

Sulzbach-Rosenberg, 92237, Germany

Location

Investigational Site Number 348205

Budapest, 1036, Hungary

Location

Investigational Site Number 348202

Budapest, 1135, Hungary

Location

Investigational Site Number 348204

Debrecen, 4032, Hungary

Location

Investigational Site Number 348208

Komárom, 2900, Hungary

Location

Investigational Site Number 348210

Nagykanizsa, 8800, Hungary

Location

Investigational Site Number 348209

Sátoraljaújhely, 3980, Hungary

Location

Investigational Site Number 348203

Szolnok, 5004, Hungary

Location

Investigational Site Number 380203

Bologna, 40138, Italy

Location

Investigational Site Number 380201

Milan, 20132, Italy

Location

Investigational Site Number 380204

Roma, 00133, Italy

Location

Investigational Site Number 380202

Sesto San Giovanni, 20099, Italy

Location

Investigational Site Number 642210

Bacau, 600154, Romania

Location

Investigational Site Number 642201

Bucharest, 020042, Romania

Location

Investigational Site Number 642202

Bucharest, 020042, Romania

Location

Investigational Site Number 642206

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number 642204

Deva, 330084, Romania

Location

Investigational Site Number 642205

Oradea, 410159, Romania

Location

Investigational Site Number 642209

Sibiu, 550371, Romania

Location

Investigational Site Number 642207

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642208

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642203

Timișoara, 300456, Romania

Location

Investigational Site Number 643201

Saint Petersburg, 190013, Russia

Location

Investigational Site Number 643203

Saint Petersburg, 194354, Russia

Location

Investigational Site Number 643204

Saint Petersburg, 194358, Russia

Location

Investigational Site Number 643202

Saint Petersburg, 195257, Russia

Location

Investigational Site Number 643205

Saratov, 410030, Russia

Location

Investigational Site Number 410202

Seoul, 110-746, South Korea

Location

Investigational Site Number 410204

Seoul, 130-872, South Korea

Location

Investigational Site Number 410205

Seoul, 139-872, South Korea

Location

Investigational Site Number 410201

Wŏnju, 220-701, South Korea

Location

Investigational Site Number 724201

Barcelona, 08035, Spain

Location

Investigational Site Number 724203

Málaga, 29010, Spain

Location

Investigational Site Number 724202

Palma de Mallorca, 07010, Spain

Location

Investigational Site Number 792201

Istanbul, 34303, Turkey (Türkiye)

Location

Investigational Site Number 792202

Istanbul, 34890, Turkey (Türkiye)

Location

Investigational Site Number 792204

Izmir, 35100, Turkey (Türkiye)

Location

Investigational Site Number 792203

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29232162 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

SAR342434; Insulin Lispro; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2014
• First Posted: November 19, 2014
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 18, 2018
• Results First Posted: January 18, 2018

Record last verified: 2017-12

Locations

RO (10); TU (4); RU (5); US (51); DE (6); HU (7); KR (4); IT (4); CO (1); CL (3); AR (5); ES (3)