BRIGHT

CompletedPhase 4Results posted

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

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

Lead sponsor

Sanofi

Asset

GLP-1 / incretin class catch-all

Listed sites

158

Recruiting sites

—

Enrollment

929

actual

Study population

Type 2 diabetes

Key I/E criterion

—

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT02738151

Org study IDLPS14584

Secondary ID2015-005101-36

Secondary IDU1111-1177-6327UTN

Timeline

Milestones

Study first posted2016-04-14estimated

Study start2016-05-19

Primary completion2017-08-15actual

Study completion2017-08-15actual

Last update posted2018-09-14actual

Results first posted2018-09-14actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (19)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Safety / tolerability / PK

Patient-reported / QoL

Glycemic / diabetes

13 endpoints

Primary/protocol endpoint

Change From Baseline in HbA1c to Week 24

Time frame:Baseline, Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Toujeo	-1.64	—
Tresiba	-1.59	—

Least Square (LS) Mean difference-0.0595% CI-0.152 – 0.051p<.0001Mixed Models Analysis

LS Mean Difference-0.0595% CI-0.152 – 0.051p0.3302Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in HbA1c to Week 12

Time frame:Baseline, Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percentage of HbA1c	95% CI
Toujeo	-1.37	—
Tresiba	-1.39	—

Secondary/protocol endpoint

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

Time frame:Baseline, Week 12 and Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
ToujeoWeek 12	-3.64	—
Week 24	-3.52	—
TresibaWeek 12	-3.89	—
Week 24	-3.95	—

Secondary/protocol endpoint

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

Time frame:Baseline, Week 12 and Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
ToujeoWeek 12	-3.26	—
Week 24	-3.23	—
TresibaWeek 12	-3.25	—
Week 24	-3.29	—

Secondary/protocol endpoint

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

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
ToujeoWeek 12: 03:00 at night	-2.77	—
Week 12: Pre-breakfast	-3.42	—
Week 12: 2 hours after breakfast	-3.20	—
Week 12: Pre-lunch	-2.64	—
Week 12: 2 hours after lunch	-2.51	—
Week 12: Pre-dinner	-2.04	—
Week 12: 2 hours after dinner	-2.32	—
Week 12: Bedtime	-2.44	—
Week 24: 03:00 at night	-2.65	—
Week 24: Pre-breakfast	-3.37	—
Week 24: 2 hours after breakfast	-3.30	—
Week 24: Pre-lunch	-2.81	—
Week 24: 2 hours after lunch	-2.74	—
Week 24: Pre-dinner	-1.87	—
Week 24: 2 hours after dinner	-2.28	—
Week 24: Bedtime	-2.52	—
TresibaWeek 12: 03:00 at night	-2.28	—
Week 12: Pre-breakfast	-3.00	—
Week 12: 2 hours after breakfast	-3.23	—
Week 12: Pre-lunch	-2.50	—
Week 12: 2 hours after lunch	-1.99	—
Week 12: Pre-dinner	-1.93	—
Week 12: 2 hours after dinner	-1.76	—
Week 12: Bedtime	-2.08	—
Week 24: 03:00 at night	-2.43	—
Week 24: Pre-breakfast	-3.03	—
Week 24: 2 hours after breakfast	-3.50	—
Week 24: Pre-lunch	-2.29	—
Week 24: 2 hours after lunch	-1.93	—
Week 24: Pre-dinner	-1.86	—
Week 24: 2 hours after dinner	-2.07	—
Week 24: Bedtime	-2.09	—

Secondary/protocol endpoint

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

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
ToujeoWeek 12: Pre-breakfast	-3.41	—
Week 12: Pre-lunch	-2.63	—
Week 12: Pre-dinner	-2.03	—
Week 12: Bedtime	-2.41	—
Week 24: Pre-breakfast	-3.38	—
Week 24: Pre-lunch	-2.81	—
Week 24: Pre-dinner	-1.88	—
Week 24: Bedtime	-2.51	—
TresibaWeek 12: Pre-breakfast	-2.97	—
Week 12: Pre-lunch	-2.44	—
Week 12: Pre-dinner	-1.92	—
Week 12: Bedtime	-2.11	—
Week 24: Pre-breakfast	-2.99	—
Week 24: Pre-lunch	-2.26	—
Week 24: Pre-dinner	-1.86	—
Week 24: Bedtime	-2.10	—

Secondary/protocol endpoint

Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), mmol/L	95% CI
ToujeoWeek 12	-2.57	—
Week 24	-2.62	—
TresibaWeek 12	-2.50	—
Week 24	-2.53	—

Secondary/protocol endpoint

Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of mean variability	95% CI
ToujeoWeek 12	2.38	—
Week 24	1.49	—
TresibaWeek 12	2.62	—
Week 24	1.97	—

Secondary/protocol endpoint

Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), percentage of mean variability	95% CI
ToujeoWeek 12	4.08	—
Week 24	3.70	—
TresibaWeek 12	4.73	—
Week 24	3.95	—

Secondary/protocol endpoint

Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24

Time frame:Week 12, and Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
ToujeoParticipants who reached the target <7% at Week 12	34.63	—
Participants who reached target <=6.5% at Week 12	11.47	—
Participants who reached the target <7% at Week 24	48.70	—
Participants who reached target <=6.5% at Week 24	21.21	—
TresibaParticipants who reached the target <7% at Week 12	36.15	—
Participants who reached target <=6.5% at Week 12	14.29	—
Participants who reached the target <7% at Week 24	44.59	—
Participants who reached target <=6.5% at Week 24	19.70	—

Secondary/protocol endpoint

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

Time frame:Week 12, and Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percentage of participants	95% CI
ToujeoWeek12: Participants who reached the target <7%	16.45	—
Week12: Participants who reached target <=6.5%	4.11	—
Week24: Participants who reached the target <7%	13.42	—
Week24: Participants who reached target <=6.5%	5.84	—
TresibaWeek12: Participants who reached the target <7%	13.64	—
Week12: Participants who reached target <=6.5%	4.55	—
Week24: Participants who reached the target <7%	12.99	—
Week24: Participants who reached target <=6.5%	5.19	—

Secondary/protocol endpoint

Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period

Time frame:Baseline to Week 24

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Toujeo	1.30	—
Tresiba	1.30	—

Secondary/protocol endpoint

Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (mean), Units per kilogram (U/kg)	95% CI
ToujeoWeek 12	0.289	—
Week 24	0.357	—
TresibaWeek 12	0.255	—
Week 24	0.309	—

Patient-reported / QoL

1 endpoint

Other/protocol endpoint

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

Time frame:Baseline, Week 12 and Week 24

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	95% CI
ToujeoWeek 12	5.08	—
Week 24	5.77	—
TresibaWeek 12	5.32	—
Week 24	5.44	—

Safety / tolerability / PK

5 endpoints

Secondary/protocol endpoint

Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period

Time frame:Baseline to Week 24

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
Toujeo	4.98	—
Tresiba	4.76	—

Secondary/protocol endpoint

Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period

Time frame:Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Documented hypoglycemia

threshold achievement, event

Posted result

Group	Value (number), percentage of participants	95% CI
ToujeoAny hypo Day1-Week 12	53.0	—
Any hypo Week13-14	57.2	—
Any hypo 24 week period	70.1	—
Severe and/or confirmed hypo (=<70mg/dL) D1-W12	47.4	—
Severe and/or confirmed hypo (=<70mg/dL) W13-14	54.1	—
Severe and/or confirmed hypo(=<70mg/dL) 24W period	66.5	—
Severe and/or confirmed hypo (< 54mg/dL) D1-W12	7.8	—
Severe and/or confirmed hypo( <54 mg/dL) W13-14	9.8	—
Severe and/or confirmed hypo (<54mg/dL) 24W period	14.7	—
TresibaAny hypo Day1-Week 12	58.4	—
Any hypo Week13-14	57.4	—
Any hypo 24 week period	71.2	—
Severe and/or confirmed hypo (=<70mg/dL) D1-W12	54.3	—
Severe and/or confirmed hypo (=<70mg/dL) W13-14	55.8	—
Severe and/or confirmed hypo(=<70mg/dL) 24W period	69.0	—
Severe and/or confirmed hypo (< 54mg/dL) D1-W12	11.7	—
Severe and/or confirmed hypo( <54 mg/dL) W13-14	11.2	—
Severe and/or confirmed hypo (<54mg/dL) 24W period	18.4	—

Secondary/protocol endpoint

Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period

Time frame:Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Documented hypoglycemia

threshold achievement, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), percentage of participants	95% CI
ToujeoAny hypo D1-W12	18.4	—
Any hypo W13-14	22.7	—
Any hypo 24Week period	31.2	—
Severe and/or confirmed hypo (=<70mg/dL)D1-W12	15.2	—
Severe and/or confirmed hypo (=<70mg/dL)W13-14	21.4	—
Severe and/or confirmed hypo(=<70mg/dL)24W Period	28.6	—
Severe and/or confirmed hypo(< 54mg/dL)D1-W12	2.8	—
Severe and/or confirmed hypo(< 54mg/dL)W13-14	4.5	—
Severe and/or confirmed hypo(< 54mg/dL)24W Period	6.1	—
TresibaAny hypo D1-W12	21.0	—
Any hypo W13-14	21.2	—
Any hypo 24Week period	30.3	—
Severe and/or confirmed hypo (=<70mg/dL)D1-W12	18.8	—
Severe and/or confirmed hypo (=<70mg/dL)W13-14	21.0	—
Severe and/or confirmed hypo(=<70mg/dL)24W Period	28.8	—
Severe and/or confirmed hypo(< 54mg/dL)D1-W12	3.5	—
Severe and/or confirmed hypo(< 54mg/dL)W13-14	3.8	—
Severe and/or confirmed hypo(< 54mg/dL)24W Period	6.1	—

Secondary/protocol endpoint

Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period

Time frame:Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Events per participant year	95% CI
ToujeoAny hypo Day1-Week12	8.93	—
Any hypo Week13-14	11.28	—
Any hypo 24 Week period	10.09	—
Severe and/or confirmed hypo (=<70mg/dL) D1-W12	8.08	—
Severe and/or confirmed hypo (=<70mg/dL) W13-14	10.64	—
Severe and/or confirmed hypo (≤70mg/dL) 24W period	9.34	—
Severe and/or confirmed hypo (< 54mg/dL) D1-W12	0.49	—
Severe and/or confirmed hypo( <54 mg/dL) W13-14	0.73	—
Severe and/or confirmed hypo (<54mg/dL) 24W period	0.61	—
TresibaAny hypo Day1-Week12	11.31	—
Any hypo Week13-14	11.60	—
Any hypo 24 Week period	11.45	—
Severe and/or confirmed hypo (=<70mg/dL) D1-W12	10.47	—
Severe and/or confirmed hypo (=<70mg/dL) W13-14	11.21	—
Severe and/or confirmed hypo (≤70mg/dL) 24W period	10.83	—
Severe and/or confirmed hypo (< 54mg/dL) D1-W12	0.86	—
Severe and/or confirmed hypo( <54 mg/dL) W13-14	0.91	—
Severe and/or confirmed hypo (<54mg/dL) 24W period	0.88	—

Secondary/protocol endpoint

Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period

Time frame:Day 1-Week 12, Week 13-Week 24, and 24 Week Period

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

Group	Value (number), Events per participant year	95% CI
ToujeoAny hypo D1-W12	1.65	—
Any hypo W13-14	2.32	—
Any hypo 24Week period	1.98	—
Severe and/or confirmed hypo(=<70mg/dL)D1-W12	1.42	—
Severe and/or confirmed hypo(=<70mg/dL)W13-14	2.24	—
Severe and/or confirmed hypo(=<70mg/dL)24W Period	1.83	—
Severe and/or confirmed hypo(< 54mg/dL)D1-W12	0.16	—
Severe and/or confirmed hypo(< 54mg/dL)W13-14	0.33	—
Severe and/or confirmed hypo(< 54mg/dL)24W Period	0.24	—
TresibaAny hypo D1-W12	2.36	—
Any hypo W13-14	2.39	—
Any hypo 24Week period	2.38	—
Severe and/or confirmed hypo(=<70mg/dL)D1-W12	2.20	—
Severe and/or confirmed hypo(=<70mg/dL)W13-14	2.33	—
Severe and/or confirmed hypo(=<70mg/dL)24W Period	2.26	—
Severe and/or confirmed hypo(< 54mg/dL)D1-W12	0.19	—
Severe and/or confirmed hypo(< 54mg/dL)W13-14	0.26	—
Severe and/or confirmed hypo(< 54mg/dL)24W Period	0.22	—

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Differential glycaemic control with basal insulin glargine 300 U/mL versus degludec 100 U/mL according to kidney function in type 2 diabetes: A subanalysis from the BRIGHT trial.
Diabetes, obesity & metabolism2020 Aug (month)PMID32243043doi:10.1111/dom.14043via pubmed nct search
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 care2018 Oct (month)PMID30104294doi:10.2337/dc18-0559via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.