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 (BRIGHT)

A 24-week, Multicenter, Randomized, Open-Label, Parallel-group StudyComparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-NaivePatients With Type 2 Diabetes Mellitus Not Adequately Controlled With OralAntihyperglycemic Drug(s) ± GLP-1 Receptor Agonist

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin glargine, 300U/mL; Drug: Non-insulin anti-diabetic treatment; Drug: Insulin degludec, 100 U/mL

Detailed Description

The maximum study duration per participant was approximately 27 weeks: an up to 2-week screening period, a 24-week randomized treatment period (including 12 weeks active titration), and a 7-day posttreatment safety follow-up period.

• Study Type: Interventional
• Enrollment (Actual): 929
• Phase: Phase 4

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1431
    • Investigational Site Number 100001
  • Sofia, Bulgaria, 1505
    • Investigational Site Number 100002
  • Sofia, Bulgaria
    • Investigational Site Number 100003
• Croatia
  • Rijeka, Croatia, 51000
    • Investigational Site Number 191001
  • Rijeka, Croatia, 51000
    • Investigational Site Number 191002
  • Zagreb, Croatia
    • Investigational Site Number 191003
• Czechia
  • Hlucin, Czechia
    • Investigational Site Number 203009
  • Jilove u Prahy, Czechia, 25401
    • Investigational Site Number 203006
  • Liberec, Czechia, 46001
    • Investigational Site Number 203005
  • Pardubice, Czechia, 53002
    • Investigational Site Number 203001
  • Praha 1, Czechia, 11000
    • Investigational Site Number 203007
  • Praha 2, Czechia, 12808
    • Investigational Site Number 203008
  • Praha 8, Czechia, 18100
    • Investigational Site Number 203002
  • Vsetin, Czechia, 75501
    • Investigational Site Number 203004
• Denmark
  • Aarhus, Denmark, 8000
    • Investigational Site Number 208003
  • Hillerød, Denmark, 3400
    • Investigational Site Number 208002
  • København NV., Denmark, 2400
    • Investigational Site Number 208001
  • Odense, Denmark, 5000
    • Investigational Site Number 208004
• France
  • La Roche Sur Yon, France, 85025
    • Investigational Site Number 250002
  • La Rochelle Cedex 1, France, 17019
    • Investigational Site Number 250003
  • Nantes cedex 01, France, 44093
    • Investigational Site Number 250001
  • Nimes, France, 30029
    • Investigational Site Number 250006
  • POITIERS Cedex, France, 86021
    • Investigational Site Number 250005
  • Venissieux, France, 69200
    • Investigational Site Number 250007
• Greece
  • Alexandroupolis, Greece, 68100
    • Investigational Site Number 300005
  • Athens, Greece
    • Investigational Site Number 300003
  • Athens, Greece, 17562
    • Investigational Site Number 300001
  • Athens, Greece
    • Investigational Site Number 300002
• Hungary
  • Budapest, Hungary, 1042
    • Investigational Site Number 348004
  • Budapest, Hungary, 1083
    • Investigational Site Number 348002
  • Budapest, Hungary, 1106
    • Investigational Site Number 348001
  • Gyöngyös, Hungary, 3200
    • Investigational Site Number 348003
• Israel
  • Haifa, Israel, 31096
    • Investigational Site Number 376001
  • Haifa, Israel
    • Investigational Site Number 376004
  • Haifa, Israel
    • Investigational Site Number 376008
  • Kfar Saba, Israel
    • Investigational Site Number 376009
  • Petach tikva, Israel
    • Investigational Site Number 376002
  • Tel Aviv, Israel
    • Investigational Site Number 376006
  • Tel Hashomer, Israel, 52621
    • Investigational Site Number 376003
  • Tel-Aviv, Israel
    • Investigational Site Number 376007
• Italy
  • Bari, Italy, 70124
    • Investigational Site Number 380007
  • Catanzaro, Italy
    • Investigational Site Number 380009
  • Chieti, Italy, 66013
    • Investigational Site Number 380010
  • Milano, Italy, 20132
    • Investigational Site Number 380014
  • Moncalieri, Italy, 10024
    • Investigational Site Number 380002
  • Napoli, Italy, 80131
    • Investigational Site Number 380011
  • Roma, Italy
    • Investigational Site Number 380008
  • Roma, Italy
    • Investigational Site Number 380015
  • Roma, Italy
    • Investigational Site Number 380016
  • Sesto San Giovanni, Italy, 20099
    • Investigational Site Number 380013
  • Torino, Italy, 10126
    • Investigational Site Number 380005
  • Verona, Italy, 37126
    • Investigational Site Number 380012
• Romania
  • Brasov, Romania, 500097
    • Investigational Site Number 642007
  • Brasov, Romania, 500326
    • Investigational Site Number 642008
  • Bucharest, Romania, 022441
    • Investigational Site Number 642001
  • Bucharest, Romania, 040172
    • Investigational Site Number 642013
  • Bucuresti, Romania
    • Investigational Site Number 642015
  • Cluj-Napoca, Romania, 400006
    • Investigational Site Number 642003
  • Constanta, Romania, 900675
    • Investigational Site Number 642009
  • Iasi, Romania, 700547
    • Investigational Site Number 642014
  • Oradea, Romania
    • Investigational Site Number 642005
  • Oradea, Romania
    • Investigational Site Number 642012
  • Targu-Mures, Romania, 540015
    • Investigational Site Number 642010
  • Targu-Mures, Romania, 540142
    • Investigational Site Number 642004
  • Targu-Mures, Romania
    • Investigational Site Number 642006
• Serbia
  • Belgrade, Serbia, 11000
    • Investigational Site Number 688001
  • Nis, Serbia
    • Investigational Site Number 688002
  • Nis, Serbia
    • Investigational Site Number 688003
• Slovakia
  • Kosice, Slovakia, 04013
    • Investigational Site Number 703006
  • Lubochna, Slovakia, 03491
    • Investigational Site Number 703002
  • Moldava nad Bodvou, Slovakia, 04525
    • Investigational Site Number 703001
  • Sabinov, Slovakia, 08301
    • Investigational Site Number 703003
  • Trebisov, Slovakia, 07501
    • Investigational Site Number 703005
• Sweden
  • Lund, Sweden, 22241
    • Investigational Site Number 752102
  • Skövde, Sweden, 54150
    • Investigational Site Number 752101
• Switzerland
  • Olten, Switzerland, 4600
    • Investigational Site Number 756003
  • St. Gallen, Switzerland, 9016
    • Investigational Site Number 756001
• United Kingdom
  • Chertsey, United Kingdom, KT160PZ
    • Investigational Site Number 826001
  • Gillingham, United Kingdom, ME75NY
    • Investigational Site Number 826005
  • Lincoln, United Kingdom, LN25QY
    • Investigational Site Number 826008
  • London, United Kingdom, SW109NH
    • Investigational Site Number 826002
  • Manchester, United Kingdom, M415SL
    • Investigational Site Number 826009
  • Margate, United Kingdom, CT94ANA
    • Investigational Site Number 826006
  • Swansea, United Kingdom, SA66NL
    • Investigational Site Number 826004
• United States
  • Alabama
    • Sheffield, Alabama, United States, 35660
      • Investigational Site Number 840038
  • Arizona
    • Phoenix, Arizona, United States, 85020
      • Investigational Site Number 840066
  • California
    • Anaheim, California, United States, 92801
      • Investigational Site Number 840051
    • Chino, California, United States, 91710
      • Investigational Site Number 840081
    • Huntington Park, California, United States, 90255
      • Investigational Site Number 840016
    • La Jolla, California, United States, 92037
      • Investigational Site Number 840002
    • Los Angeles, California, United States, 90017
      • Investigational Site Number 840091
    • Northridge, California, United States, 91324
      • Investigational Site Number 840058
    • Palm Springs, California, United States, 92262
      • Investigational Site Number 840021
    • Santa Ana, California, United States, 92704
      • Investigational Site Number 840087
    • Torrance, California, United States, 90505
      • Investigational Site Number 840030
    • Van Nuys, California, United States, 91405
      • Investigational Site Number 840065
  • Florida
    • Bradenton, Florida, United States, 34201
      • Investigational Site Number 840075
    • New Port Richey, Florida, United States, 34652
      • Investigational Site Number 840076
    • Ocoee, Florida, United States, 34761
      • Investigational Site Number 840026
    • Palm Harbor, Florida, United States, 34684
      • Investigational Site Number 840052
    • Palm Harbor, Florida, United States, 34684
      • Investigational Site Number 840080
    • Port Charlotte, Florida, United States, 33952
      • Investigational Site Number 840018
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Investigational Site Number 840071
    • Roswell, Georgia, United States, 30076
      • Investigational Site Number 840085
    • Statesboro, Georgia, United States, 30461
      • Investigational Site Number 840072
    • Stockbridge, Georgia, United States, 30281
      • Investigational Site Number 840039
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Investigational Site Number 840036
    • Chicago, Illinois, United States, 60616
      • Investigational Site Number 840010
  • Indiana
    • Avon, Indiana, United States, 46123
      • Investigational Site Number 840005
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
      • Investigational Site Number 840063
    • Des Moines, Iowa, United States, 50134
      • Investigational Site Number 840098
    • Des Moines, Iowa, United States, 50314
      • Investigational Site Number 840101
    • West Des Moines, Iowa, United States, 50266
      • Investigational Site Number 840096
  • Kentucky
    • Paris, Kentucky, United States, 40361
      • Investigational Site Number 840061
  • Maryland
    • Hyattsville, Maryland, United States, 20782
      • Investigational Site Number 840011
    • Rockville, Maryland, United States, 20852
      • Investigational Site Number 840001
  • Michigan
    • Flint, Michigan, United States, 48504
      • Investigational Site Number 840041
    • Flint, Michigan, United States, 48532
      • Investigational Site Number 840057
    • Troy, Michigan, United States, 48085
      • Investigational Site Number 840033
  • Mississippi
    • Olive Branch, Mississippi, United States, 38654
      • Investigational Site Number 840084
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Investigational Site Number 840048
  • Nevada
    • Las Vegas, Nevada, United States, 89117
      • Investigational Site Number 840023
    • Las Vegas, Nevada, United States, 89128
      • Investigational Site Number 840045
  • New Jersey
    • Linden, New Jersey, United States, 07036
      • Investigational Site Number 840031
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Investigational Site Number 840060
    • Morganton, North Carolina, United States, 28655
      • Investigational Site Number 840064
    • Wilmington, North Carolina, United States, 28401
      • Investigational Site Number 840043
    • Winston-Salem, North Carolina, United States, 27103
      • Investigational Site Number 840082
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Investigational Site Number 840025
    • Oklahoma City, Oklahoma, United States, 73112
      • Investigational Site Number 840022
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
      • Investigational Site Number 840029
    • Downingtown, Pennsylvania, United States, 19335
      • Investigational Site Number 840056
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Investigational Site Number 840093
    • Greenville, South Carolina, United States, 29605
      • Investigational Site Number 840097
    • Greer, South Carolina, United States, 29651
      • Investigational Site Number 840070
    • North Myrtle Beach, South Carolina, United States, 29582
      • Investigational Site Number 840044
    • Simpsonville, South Carolina, United States, 29681
      • Investigational Site Number 840069
  • Tennessee
    • Bristol, Tennessee, United States
      • Investigational Site Number 840079
    • Chattanooga, Tennessee, United States, 37404
      • Investigational Site Number 840006
    • Knoxville, Tennessee, United States, 37912
      • Investigational Site Number 840088
    • New Tazewell, Tennessee, United States, 37825
      • Investigational Site Number 840077
  • Texas
    • Dallas, Texas, United States, 75230
      • Investigational Site Number 840007
    • Dallas, Texas, United States, 75231
      • Investigational Site Number 840086
    • Houston, Texas, United States, 77061
      • Investigational Site Number 840027
    • Houston, Texas, United States, 77083-4436
      • Investigational Site Number 840004
    • Houston, Texas, United States, 77090
      • Investigational Site Number 840040
    • Houston, Texas, United States, 77095
      • Investigational Site Number 840046
    • Hurst, Texas, United States, 76054
      • Investigational Site Number 840054
    • Mesquite, Texas, United States, 75149
      • Investigational Site Number 840017
    • Missouri City, Texas, United States, 77459
      • Investigational Site Number 840008
    • San Antonio, Texas, United States, 78229-3907
      • Investigational Site Number 840094
    • Sugar Land, Texas, United States, 77478
      • Investigational Site Number 840009
    • Waco, Texas, United States, 76710
      • Investigational Site Number 840053
  • Utah
    • Ogden, Utah, United States, 84405
      • Investigational Site Number 840095
    • Salt Lake City, Utah, United States, 84102
      • Investigational Site Number 840032
  • Virginia
    • Norfolk, Virginia, United States
      • Investigational Site Number 840024
    • Richmond, Virginia, United States, 23219
      • Investigational Site Number 840020
  • Washington
    • Renton, Washington, United States, 98055
      • Investigational Site Number 840012

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• 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.

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Toujeo; 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; 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).; Other Names: Toujeo; HOE901-U300; Drug: Non-insulin anti-diabetic treatment; Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
ACTIVE_COMPARATOR: Tresiba; Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .	Drug: Non-insulin anti-diabetic treatment; Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.; Drug: 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; Other Names: Tresiba

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in HbA1c to Week 12	Change in HbA1c was calculated by subtracting baseline value from Week 12 value. Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.	Baseline, Week 12
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24	Change in FPG was calculated by subtracting baseline value from Week 12 and Week 24 value. Adjusted LS means were obtained from MMRM including post baseline values during the 24-week on-treatment period.	Baseline, Week 12 and Week 24
Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24	Fasting SMPG was measured by the participant before breakfast and before the administration of the glucose-lowering agents once a day during the study. Adjusted LS means were obtained from MMRM including post baseline values during the 24 week on treatment period.	Baseline, Week 12 and Week 24
Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point	8-point SMPG profiles were measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime.	Baseline, Week 12 and Week 24
Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point	4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime.	Baseline, Week 12 and Week 24
Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24	The 8-point SMPG profile was measured at the following 8 points: 03:00 at night, pre-breakfast, 2 hours after breakfast, pre-lunch, 2 hours after lunch, pre-dinner, 2 hours after dinner, and bedtime. Adjusted LS means were obtained from MMRM.	Baseline, Week 12 and Week 24
Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24	Adjusted LS means were obtained from MMRM. Variability was assessed by the mean of coefficient of variation calculated over at least 3 SMPG measured during the 7 days preceding the given visit.	Baseline, Week 12 and Week 24
Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24	Adjusted LS means were obtained from MMRM.	Baseline, Week 12 and Week 24
Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24	Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis.	Week 12, and Week 24
Percentage of Participants Reaching Target HbA1c <7% and =<6.5% at Week 12 and Week 24 Without Severe and/or Confirmed Hypoglycemia (70 mg/dL) Event	Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed by plasma glucose =<3.9 mmol/L (=<70 mg/dL).	Week 12, and Week 24
Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period	Percentage of participants With Sulphonylurea or Meglitinide dose reduction/ discontinuation due to Hypoglycemia during 24 Week treatment period were reported. Only participants with Sulphonylurea or meglitinides at Screening as per actual strata were taken into account in this analysis.	Baseline to Week 24
Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period	Routine fasting SMPG and central laboratory FPG (and HbA1c after Week 12) values were used to determine the requirement of rescue medication. Threshold values at Week 12: FPG >200 mg/dL (11 mmol/L), or HbA1c >8.5%.	Baseline to Week 24
Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24	Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis.	Baseline, Week 12 and Week 24
Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period	Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks (24W)). Percentage of participants with at least one hypoglycemia (hypo) event at any time of the day were reported.	Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period	Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycaemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time). Assessment was done by treatment period (for =<12 weeks, for >12 weeks to =<24 weeks).	Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period	Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L).	Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period	Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Severe and/or confirmed hypoglycemia event was a severe event or an event confirmed with plasma glucose =<70 mg/dL (=<3.9 mmol/L), or < 54 mg/dL (<3.0 mmol/L). Nocturnal hypoglycemia was hypoglycemia that occurred between 00:00 and 05:59 hours (clock time).	Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24	The DTSQs is a validated questionnaire to assess participant's satisfaction with their diabetes treatment. It consists of 8 items that are answered on a Likert scale from 0 to 6. Total treatment satisfaction score is the sum of items 1, 4-8 scores and ranged from 0 (no satisfaction) to 36 (high satisfaction with treatment). Adjusted least square means and standard errors were obtained from a mixed-effect model with MMRM.	Baseline, Week 12 and Week 24

Collaborators and Investigators

• Sponsor: Sanofi

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 19, 2016
• Primary Completion (ACTUAL): August 15, 2017
• Study Completion (ACTUAL): August 15, 2017

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (ESTIMATE): April 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): September 14, 2018
• Last Update Submitted That Met QC Criteria: August 14, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Insulin Glargine
• Other Study ID Numbers: LPS14584; 2015-005101-36 (EUDRACT_NUMBER); U1111-1177-6327 (OTHER: UTN)