Efficacy and Safety of Toujeo® Versus Tresiba® in Insulin-Naive Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

NCT02738151 | Completed Phase 4 Results

• 3 other identifiers: LPS145842015-005101-36U1111-1177-6327
• Study Type: interventional
• Target: 929
• Locations: 15 countries
• Sites: 156

Brief Summary

Primary Objective: To demonstrate the noninferiority in the efficacy of Toujeo® to Tresiba® in glycated hemoglobin (HbA1c) change from Baseline to Week 24. Secondary Objectives: Change From Baseline in HbA1c to Week 12 To assess the effects of the insulin Toujeo® in comparison with insulin Tresiba® at week 12 and week 24 on:

• Change in Fasting plasma glucose (FPG);
• Change in Fasting self-monitored plasma glucose (SMPG) and 4-point SMPG and 8-point SMPG profile;
• Percentage of participants reaching HbA1c targets \<7% or ≤6.5%;
• Percentage of participants reaching HbA1c targets \<7% or ≤6.5% without severe and/or confirmed hypoglycemia
• Frequency of occurrence and diurnal distribution of hypoglycemia by American Diabetes Association (ADA) category of hypoglycemia. To assess the safety in each treatment group. To assess the treatment effects in each treatment group on Patient Reported Outcomes (PRO). Percentage of participants requiring rescue therapy.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c to Week 24

  Change in HbA1c was calculated by subtracting baseline value from Week 24 value. Adjusted Least Square (LS) 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 24-week on-treatment period.

  Baseline, Week 24

Secondary Outcomes (17)

• Change From Baseline in HbA1c to Week 12

  Baseline, Week 12

• Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24

  Baseline, Week 12 and Week 24

• Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24

  Baseline, Week 12 and Week 24

• Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point

  Baseline, Week 12 and Week 24

• Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point

  Baseline, Week 12 and Week 24

Other Outcomes (1)

• Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24

  Baseline, Week 12 and Week 24

Study Arms (2)

Toujeo

EXPERIMENTAL

Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

Drug: Insulin glargine, 300U/mL; Drug: Non-insulin anti-diabetic treatment

Tresiba

ACTIVE COMPARATOR

Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .

Drug: Insulin degludec, 100 U/mL; Drug: Non-insulin anti-diabetic treatment

Interventions

Insulin glargine, 300U/mL DRUG

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).

Also known as: HOE901-U300, Toujeo

Toujeo

Insulin degludec, 100 U/mL DRUG

Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L). Route of administration: subcutaneous

Also known as: Tresiba

Tresiba

Non-insulin anti-diabetic treatment DRUG

Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.

Toujeo; Tresiba

Eligibility Criteria

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

You may qualify if:

• Adult participants with type 2 diabetes mellitus (T2DM) inadequately controlled with OADs therapy with/without GLP-1 receptor agonist at stable dose for at least 3 months.
• Signed written informed consent.

You may not qualify if:

• Age \<18 years.
• HbA1c \<7.5% or \>10.5% (at screening visit). Body mass index (BMI) \<25 kg/m\^2 or \>40 kg/m\^2.
• History of T2DM for less than 1 year before screening.
• Less than 6 months before screening on OADs treatment and GLP-1 receptor agonist (if taken).
• Current or previous insulin use except for a maximum of 8 consecutive days or totally 15 days (eg, acute illness, surgery) during the last year prior to screening.
• Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit.
• Participant receiving only noninsulin antihyperglycemic drugs not approved for combination with insulin according to local labelling/local treatment guideline.
• History of hypoglycemia unawareness or repeated episodes of severe hypoglycemia or metabolic acidosis, including hospitalization for diabetic ketoacidosis during the last 12 months prior to screening.
• 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.
• End stage renal disease.
• Any acute or chronic condition that in the opinion of Investigator would affect the safety of participant, compliance, or study results.
• Any contraindication to use of Toujeo® or Tresiba® as defined in the national product label, hypersensitivity to Toujeo® or Tresiba® active ingredients or one of the excipients.
• Pregnant or breast-feeding women.
• 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 (158)

Investigational Site Number 840038

Sheffield, Alabama, 35660, United States

Location

Investigational Site Number 840066

Phoenix, Arizona, 85020, United States

Location

Investigational Site Number 840051

Anaheim, California, 92801, United States

Location

Investigational Site Number 840081

Chino, California, 91710, United States

Location

Investigational Site Number 840016

Huntington Park, California, 90255, United States

Location

Investigational Site Number 840002

La Jolla, California, 92037, United States

Location

Investigational Site Number 840091

Los Angeles, California, 90017, United States

Location

Investigational Site Number 840058

Northridge, California, 91324, United States

Location

Investigational Site Number 840021

Palm Springs, California, 92262, United States

Location

Investigational Site Number 840087

Santa Ana, California, 92704, United States

Location

Investigational Site Number 840030

Torrance, California, 90505, United States

Location

Investigational Site Number 840065

Van Nuys, California, 91405, United States

Location

Investigational Site Number 840075

Bradenton, Florida, 34201, United States

Location

Investigational Site Number 840076

New Port Richey, Florida, 34652, United States

Location

Investigational Site Number 840026

Ocoee, Florida, 34761, United States

Location

Investigational Site Number 840052

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840080

Palm Harbor, Florida, 34684, United States

Location

Investigational Site Number 840018

Port Charlotte, Florida, 33952, United States

Location

Investigational Site Number 840071

Lawrenceville, Georgia, 30046, United States

Location

Investigational Site Number 840085

Roswell, Georgia, 30076, United States

Location

Investigational Site Number 840072

Statesboro, Georgia, 30461, United States

Location

Investigational Site Number 840039

Stockbridge, Georgia, 30281, United States

Location

Investigational Site Number 840036

Arlington Heights, Illinois, 60005, United States

Location

Investigational Site Number 840010

Chicago, Illinois, 60616, United States

Location

Investigational Site Number 840005

Avon, Indiana, 46123, United States

Location

Investigational Site Number 840063

Council Bluffs, Iowa, 51501, United States

Location

Investigational Site Number 840098

Des Moines, Iowa, 50134, United States

Location

Investigational Site Number 840101

Des Moines, Iowa, 50314, United States

Location

Investigational Site Number 840096

West Des Moines, Iowa, 50266, United States

Location

Investigational Site Number 840061

Paris, Kentucky, 40361, United States

Location

Investigational Site Number 840011

Hyattsville, Maryland, 20782, United States

Location

Investigational Site Number 840001

Rockville, Maryland, 20852, United States

Location

Investigational Site Number 840041

Flint, Michigan, 48504, United States

Location

Investigational Site Number 840057

Flint, Michigan, 48532, United States

Location

Investigational Site Number 840033

Troy, Michigan, 48085, United States

Location

Investigational Site Number 840084

Olive Branch, Mississippi, 38654, United States

Location

Investigational Site Number 840048

Chesterfield, Missouri, 63017, United States

Location

Investigational Site Number 840023

Las Vegas, Nevada, 89117, United States

Location

Investigational Site Number 840045

Las Vegas, Nevada, 89128, United States

Location

Investigational Site Number 840031

Linden, New Jersey, 07036, United States

Location

Investigational Site Number 840060

Hickory, North Carolina, 28601, United States

Location

Investigational Site Number 840064

Morganton, North Carolina, 28655, United States

Location

Investigational Site Number 840043

Wilmington, North Carolina, 28401, United States

Location

Investigational Site Number 840082

Winston-Salem, North Carolina, 27103, United States

Location

Investigational Site Number 840025

Oklahoma City, Oklahoma, 73104, United States

Location

Investigational Site Number 840022

Oklahoma City, Oklahoma, 73112, United States

Location

Investigational Site Number 840029

Beaver, Pennsylvania, 15009, United States

Location

Investigational Site Number 840056

Downingtown, Pennsylvania, 19335, United States

Location

Investigational Site Number 840093

Anderson, South Carolina, 29621, United States

Location

Investigational Site Number 840097

Greenville, South Carolina, 29605, United States

Location

Investigational Site Number 840070

Greer, South Carolina, 29651, United States

Location

Investigational Site Number 840044

North Myrtle Beach, South Carolina, 29582, United States

Location

Investigational Site Number 840069

Simpsonville, South Carolina, 29681, United States

Location

Investigational Site Number 840079

Bristol, Tennessee, United States

Location

Investigational Site Number 840006

Chattanooga, Tennessee, 37404, United States

Location

Investigational Site Number 840088

Knoxville, Tennessee, 37912, United States

Location

Investigational Site Number 840077

New Tazewell, Tennessee, 37825, United States

Location

Investigational Site Number 840007

Dallas, Texas, 75230, United States

Location

Investigational Site Number 840086

Dallas, Texas, 75231, United States

Location

Investigational Site Number 840027

Houston, Texas, 77061, United States

Location

Investigational Site Number 840004

Houston, Texas, 77083-4436, United States

Location

Investigational Site Number 840040

Houston, Texas, 77090, United States

Location

Investigational Site Number 840046

Houston, Texas, 77095, United States

Location

Investigational Site Number 840054

Hurst, Texas, 76054, United States

Location

Investigational Site Number 840017

Mesquite, Texas, 75149, United States

Location

Investigational Site Number 840008

Missouri City, Texas, 77459, United States

Location

Investigational Site Number 840094

San Antonio, Texas, 78229-3907, United States

Location

Investigational Site Number 840009

Sugar Land, Texas, 77478, United States

Location

Investigational Site Number 840053

Waco, Texas, 76710, United States

Location

Investigational Site Number 840095

Ogden, Utah, 84405, United States

Location

Investigational Site Number 840032

Salt Lake City, Utah, 84102, United States

Location

Investigational Site Number 840024

Norfolk, Virginia, United States

Location

Investigational Site Number 840020

Richmond, Virginia, 23219, United States

Location

Investigational Site Number 840012

Renton, Washington, 98055, United States

Location

Investigational Site Number 100001

Sofia, 1431, Bulgaria

Location

Investigational Site Number 100002

Sofia, 1505, Bulgaria

Location

Investigational Site Number 100003

Sofia, Bulgaria

Location

Investigational Site Number 191001

Rijeka, 51000, Croatia

Location

Investigational Site Number 191002

Rijeka, 51000, Croatia

Location

Investigational Site Number 191003

Zagreb, Croatia

Location

Investigational Site Number 203009

Hlučín, Czechia

Location

Investigational Site Number 203006

Jílové u Prahy, 25401, Czechia

Location

Investigational Site Number 203005

Liberec, 46001, Czechia

Location

Investigational Site Number 203001

Pardubice, 53002, Czechia

Location

Investigational Site Number 203007

Prague, 11000, Czechia

Location

Investigational Site Number 203008

Prague, 12808, Czechia

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Investigational Site Number 203002

Prague, 18100, Czechia

Location

Investigational Site Number 203004

Vsetín, 75501, Czechia

Location

Investigational Site Number 208003

Aarhus, 8000, Denmark

Location

Investigational Site Number 208002

Hillerød, 3400, Denmark

Location

Investigational Site Number 208001

København NV, 2400, Denmark

Location

Investigational Site Number 208004

Odense, 5000, Denmark

Location

Investigational Site Number 250002

La Roche-sur-Yon, 85025, France

Location

Investigational Site Number 250003

La Rochelle, 17019, France

Location

Investigational Site Number 250001

Nantes, 44093, France

Location

Investigational Site Number 250006

Nîmes, 30029, France

Location

Investigational Site Number 250005

Poitiers, 86021, France

Location

Investigational Site Number 250007

Vénissieux, 69200, France

Location

Investigational Site Number 300005

Alexandroupoli, 68100, Greece

Location

Investigational Site Number 300001

Athens, 17562, Greece

Location

Investigational Site Number 300002

Athens, Greece

Location

Investigational Site Number 300003

Athens, Greece

Location

Investigational Site Number 348004

Budapest, 1042, Hungary

Location

Investigational Site Number 348002

Budapest, 1083, Hungary

Location

Investigational Site Number 348001

Budapest, 1106, Hungary

Location

Investigational Site Number 348003

Gyöngyös, 3200, Hungary

Location

Investigational Site Number 376001

Haifa, 31096, Israel

Location

Investigational Site Number 376004

Haifa, Israel

Location

Investigational Site Number 376008

Haifa, Israel

Location

Investigational Site Number 376009

Kfar Saba, Israel

Location

Investigational Site Number 376002

Petah Tikva, Israel

Location

Investigational Site Number 376006

Tel Aviv, Israel

Location

Investigational Site Number 376007

Tel Aviv, Israel

Location

Investigational Site Number 376003

Tel Litwinsky, 52621, Israel

Location

Investigational Site Number 380007

Bari, 70124, Italy

Location

Investigational Site Number 380009

Catanzaro, Italy

Location

Investigational Site Number 380010

Chieti, 66013, Italy

Location

Investigational Site Number 380014

Milan, 20132, Italy

Location

Investigational Site Number 380002

Moncalieri, 10024, Italy

Location

Investigational Site Number 380011

Napoli, 80131, Italy

Location

Investigational Site Number 380008

Roma, Italy

Location

Investigational Site Number 380015

Roma, Italy

Location

Investigational Site Number 380016

Roma, Italy

Location

Investigational Site Number 380013

Sesto San Giovanni, 20099, Italy

Location

Investigational Site Number 380005

Torino, 10126, Italy

Location

Investigational Site Number 380012

Verona, 37126, Italy

Location

Investigational Site Number 642007

Brasov, 500097, Romania

Location

Investigational Site Number 642008

Brasov, 500326, Romania

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Investigational Site Number 642001

Bucharest, 022441, Romania

Location

Investigational Site Number 642013

Bucharest, 040172, Romania

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Investigational Site Number 642015

Bucharest, Romania

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Investigational Site Number 642003

Cluj-Napoca, 400006, Romania

Location

Investigational Site Number 642009

Constanța, 900675, Romania

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Investigational Site Number 642014

Iași, 700547, Romania

Location

Investigational Site Number 642005

Oradea, Romania

Location

Investigational Site Number 642012

Oradea, Romania

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Investigational Site Number 642010

Târgu Mureş, 540015, Romania

Location

Investigational Site Number 642004

Târgu Mureş, 540142, Romania

Location

Investigational Site Number 642006

Târgu Mureş, Romania

Location

Investigational Site Number 688001

Belgrade, 11000, Serbia

Location

Investigational Site Number 688002

Niš, Serbia

Location

Investigational Site Number 688003

Niš, Serbia

Location

Investigational Site Number 703006

Košice, 04013, Slovakia

Location

Investigational Site Number 703002

Ľubochňa, 03491, Slovakia

Location

Investigational Site Number 703001

Moldava nad Bodvou, 04525, Slovakia

Location

Investigational Site Number 703003

Sabinov, 08301, Slovakia

Location

Investigational Site Number 703005

Trebišov, 07501, Slovakia

Location

Investigational Site Number 752102

Lund, 22241, Sweden

Location

Investigational Site Number 752101

Skövde, 54150, Sweden

Location

Investigational Site Number 756003

Olten, 4600, Switzerland

Location

Investigational Site Number 756001

Sankt Gallen, 9016, Switzerland

Location

Investigational Site Number 826001

Chertsey, KT160PZ, United Kingdom

Location

Investigational Site Number 826005

Gillingham, ME75NY, United Kingdom

Location

Investigational Site Number 826008

Lincoln, LN25QY, United Kingdom

Location

Investigational Site Number 826002

London, SW109NH, United Kingdom

Location

Investigational Site Number 826009

Manchester, M415SL, United Kingdom

Location

Investigational Site Number 826006

Margate, CT94ANA, United Kingdom

Location

Investigational Site Number 826004

Swansea, SA66NL, United Kingdom

Location

Related Publications (1)

• Rosenstock J, Cheng A, Ritzel R, Bosnyak Z, Devisme C, Cali AMG, Sieber J, Stella P, Wang X, Frias JP, Roussel R, Bolli GB. More Similarities Than Differences Testing Insulin Glargine 300 Units/mL Versus Insulin Degludec 100 Units/mL in Insulin-Naive Type 2 Diabetes: The Randomized Head-to-Head BRIGHT Trial. Diabetes Care. 2018 Oct;41(10):2147-2154. doi: 10.2337/dc18-0559. Epub 2018 Aug 13.

  PMID: 30104294 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; insulin degludec

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi

Contact-US@sanofi.com

800-633-1610

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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2016
• First Posted: April 14, 2016
• Study Start: May 19, 2016
• Primary Completion: August 15, 2017
• Study Completion: August 15, 2017
• Last Updated: September 14, 2018
• Results First Posted: September 14, 2018

Record last verified: 2018-08

Locations

CH (2); GB (7); SL (5); IL (8); FR (6); HU (4); RO (13); GR (4); CR (3); SE (3); BU (3); IT (12); US (74); CZ (8); DK (4)