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
NCT ID: NCT02738151
Last Updated: 2018-09-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
929 participants
INTERVENTIONAL
2016-05-19
2017-08-15
Brief Summary
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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.
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Twelve -Month Study Observing How Insulin-naïve Patients With Type 2 Diabetes Mellitus Manage Diabetes Using Toujeo® After Oral Antidiabetic Drug Failure, the Side Effect of Toujeo®, and The Cost.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Toujeo
Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
Insulin glargine, 300U/mL
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).
Non-insulin anti-diabetic treatment
Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
Tresiba
Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .
Insulin degludec, 100 U/mL
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
Non-insulin anti-diabetic treatment
Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
Interventions
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Insulin glargine, 300U/mL
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).
Insulin degludec, 100 U/mL
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
Non-insulin anti-diabetic treatment
Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number 840038
Sheffield, Alabama, United States
Investigational Site Number 840066
Phoenix, Arizona, United States
Investigational Site Number 840051
Anaheim, California, United States
Investigational Site Number 840081
Chino, California, United States
Investigational Site Number 840016
Huntington Park, California, United States
Investigational Site Number 840002
La Jolla, California, United States
Investigational Site Number 840091
Los Angeles, California, United States
Investigational Site Number 840058
Northridge, California, United States
Investigational Site Number 840021
Palm Springs, California, United States
Investigational Site Number 840087
Santa Ana, California, United States
Investigational Site Number 840030
Torrance, California, United States
Investigational Site Number 840065
Van Nuys, California, United States
Investigational Site Number 840075
Bradenton, Florida, United States
Investigational Site Number 840076
New Port Richey, Florida, United States
Investigational Site Number 840026
Ocoee, Florida, United States
Investigational Site Number 840052
Palm Harbor, Florida, United States
Investigational Site Number 840080
Palm Harbor, Florida, United States
Investigational Site Number 840018
Port Charlotte, Florida, United States
Investigational Site Number 840071
Lawrenceville, Georgia, United States
Investigational Site Number 840085
Roswell, Georgia, United States
Investigational Site Number 840072
Statesboro, Georgia, United States
Investigational Site Number 840039
Stockbridge, Georgia, United States
Investigational Site Number 840036
Arlington Heights, Illinois, United States
Investigational Site Number 840010
Chicago, Illinois, United States
Investigational Site Number 840005
Avon, Indiana, United States
Investigational Site Number 840063
Council Bluffs, Iowa, United States
Investigational Site Number 840098
Des Moines, Iowa, United States
Investigational Site Number 840101
Des Moines, Iowa, United States
Investigational Site Number 840096
West Des Moines, Iowa, United States
Investigational Site Number 840061
Paris, Kentucky, United States
Investigational Site Number 840011
Hyattsville, Maryland, United States
Investigational Site Number 840001
Rockville, Maryland, United States
Investigational Site Number 840041
Flint, Michigan, United States
Investigational Site Number 840057
Flint, Michigan, United States
Investigational Site Number 840033
Troy, Michigan, United States
Investigational Site Number 840084
Olive Branch, Mississippi, United States
Investigational Site Number 840048
Chesterfield, Missouri, United States
Investigational Site Number 840023
Las Vegas, Nevada, United States
Investigational Site Number 840045
Las Vegas, Nevada, United States
Investigational Site Number 840031
Linden, New Jersey, United States
Investigational Site Number 840060
Hickory, North Carolina, United States
Investigational Site Number 840064
Morganton, North Carolina, United States
Investigational Site Number 840043
Wilmington, North Carolina, United States
Investigational Site Number 840082
Winston-Salem, North Carolina, United States
Investigational Site Number 840025
Oklahoma City, Oklahoma, United States
Investigational Site Number 840022
Oklahoma City, Oklahoma, United States
Investigational Site Number 840029
Beaver, Pennsylvania, United States
Investigational Site Number 840056
Downingtown, Pennsylvania, United States
Investigational Site Number 840093
Anderson, South Carolina, United States
Investigational Site Number 840097
Greenville, South Carolina, United States
Investigational Site Number 840070
Greer, South Carolina, United States
Investigational Site Number 840044
North Myrtle Beach, South Carolina, United States
Investigational Site Number 840069
Simpsonville, South Carolina, United States
Investigational Site Number 840079
Bristol, Tennessee, United States
Investigational Site Number 840006
Chattanooga, Tennessee, United States
Investigational Site Number 840088
Knoxville, Tennessee, United States
Investigational Site Number 840077
New Tazewell, Tennessee, United States
Investigational Site Number 840007
Dallas, Texas, United States
Investigational Site Number 840086
Dallas, Texas, United States
Investigational Site Number 840027
Houston, Texas, United States
Investigational Site Number 840004
Houston, Texas, United States
Investigational Site Number 840040
Houston, Texas, United States
Investigational Site Number 840046
Houston, Texas, United States
Investigational Site Number 840054
Hurst, Texas, United States
Investigational Site Number 840017
Mesquite, Texas, United States
Investigational Site Number 840008
Missouri City, Texas, United States
Investigational Site Number 840094
San Antonio, Texas, United States
Investigational Site Number 840009
Sugar Land, Texas, United States
Investigational Site Number 840053
Waco, Texas, United States
Investigational Site Number 840095
Ogden, Utah, United States
Investigational Site Number 840032
Salt Lake City, Utah, United States
Investigational Site Number 840024
Norfolk, Virginia, United States
Investigational Site Number 840020
Richmond, Virginia, United States
Investigational Site Number 840012
Renton, Washington, United States
Investigational Site Number 100001
Sofia, , Bulgaria
Investigational Site Number 100002
Sofia, , Bulgaria
Investigational Site Number 100003
Sofia, , Bulgaria
Investigational Site Number 191001
Rijeka, , Croatia
Investigational Site Number 191002
Rijeka, , Croatia
Investigational Site Number 191003
Zagreb, , Croatia
Investigational Site Number 203009
Hlučín, , Czechia
Investigational Site Number 203006
Jílové u Prahy, , Czechia
Investigational Site Number 203005
Liberec, , Czechia
Investigational Site Number 203001
Pardubice, , Czechia
Investigational Site Number 203007
Prague, , Czechia
Investigational Site Number 203008
Prague, , Czechia
Investigational Site Number 203002
Prague, , Czechia
Investigational Site Number 203004
Vsetín, , Czechia
Investigational Site Number 208003
Aarhus, , Denmark
Investigational Site Number 208002
Hillerød, , Denmark
Investigational Site Number 208001
København NV, , Denmark
Investigational Site Number 208004
Odense, , Denmark
Investigational Site Number 250002
La Roche-sur-Yon, , France
Investigational Site Number 250003
La Rochelle, , France
Investigational Site Number 250001
Nantes, , France
Investigational Site Number 250006
Nîmes, , France
Investigational Site Number 250005
Poitiers, , France
Investigational Site Number 250007
Vénissieux, , France
Investigational Site Number 300005
Alexandroupoli, , Greece
Investigational Site Number 300001
Athens, , Greece
Investigational Site Number 300002
Athens, , Greece
Investigational Site Number 300003
Athens, , Greece
Investigational Site Number 348004
Budapest, , Hungary
Investigational Site Number 348002
Budapest, , Hungary
Investigational Site Number 348001
Budapest, , Hungary
Investigational Site Number 348003
Gyöngyös, , Hungary
Investigational Site Number 376001
Haifa, , Israel
Investigational Site Number 376004
Haifa, , Israel
Investigational Site Number 376008
Haifa, , Israel
Investigational Site Number 376009
Kfar Saba, , Israel
Investigational Site Number 376002
Petah Tikva, , Israel
Investigational Site Number 376006
Tel Aviv, , Israel
Investigational Site Number 376007
Tel Aviv, , Israel
Investigational Site Number 376003
Tel Litwinsky, , Israel
Investigational Site Number 380007
Bari, , Italy
Investigational Site Number 380009
Catanzaro, , Italy
Investigational Site Number 380010
Chieti, , Italy
Investigational Site Number 380014
Milan, , Italy
Investigational Site Number 380002
Moncalieri, , Italy
Investigational Site Number 380011
Napoli, , Italy
Investigational Site Number 380008
Roma, , Italy
Investigational Site Number 380015
Roma, , Italy
Investigational Site Number 380016
Roma, , Italy
Investigational Site Number 380013
Sesto San Giovanni, , Italy
Investigational Site Number 380005
Torino, , Italy
Investigational Site Number 380012
Verona, , Italy
Investigational Site Number 642007
Brasov, , Romania
Investigational Site Number 642008
Brasov, , Romania
Investigational Site Number 642001
Bucharest, , Romania
Investigational Site Number 642013
Bucharest, , Romania
Investigational Site Number 642015
Bucharest, , Romania
Investigational Site Number 642003
Cluj-Napoca, , Romania
Investigational Site Number 642009
Constanța, , Romania
Investigational Site Number 642014
Iași, , Romania
Investigational Site Number 642005
Oradea, , Romania
Investigational Site Number 642012
Oradea, , Romania
Investigational Site Number 642010
Târgu Mureş, , Romania
Investigational Site Number 642004
Târgu Mureş, , Romania
Investigational Site Number 642006
Târgu Mureş, , Romania
Investigational Site Number 688001
Belgrade, , Serbia
Investigational Site Number 688002
Niš, , Serbia
Investigational Site Number 688003
Niš, , Serbia
Investigational Site Number 703006
Košice, , Slovakia
Investigational Site Number 703002
Ľubochňa, , Slovakia
Investigational Site Number 703001
Moldava nad Bodvou, , Slovakia
Investigational Site Number 703003
Sabinov, , Slovakia
Investigational Site Number 703005
Trebišov, , Slovakia
Investigational Site Number 752102
Lund, , Sweden
Investigational Site Number 752101
Skövde, , Sweden
Investigational Site Number 756003
Olten, , Switzerland
Investigational Site Number 756001
Sankt Gallen, , Switzerland
Investigational Site Number 826001
Chertsey, , United Kingdom
Investigational Site Number 826005
Gillingham, , United Kingdom
Investigational Site Number 826008
Lincoln, , United Kingdom
Investigational Site Number 826002
London, , United Kingdom
Investigational Site Number 826009
Manchester, , United Kingdom
Investigational Site Number 826006
Margate, , United Kingdom
Investigational Site Number 826004
Swansea, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-005101-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1177-6327
Identifier Type: OTHER
Identifier Source: secondary_id
LPS14584
Identifier Type: -
Identifier Source: org_study_id
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