Study S002664

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

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02738151
Acronym: BRIGHT
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE4
Masking: NONE
Status: COMPLETED
Enrollment: 929
Start: 2016-05-19
Primary completion: 2017-08-15
Lead sponsor: Sanofi
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG:Insulin glargine, 300U/mL; DRUG:Insulin degludec, 100 U/mL; DRUG:Non-insulin anti-diabetic treatment
Results posted: TRUE
Secondary identifiers: EUDRACT_NUMBER:2015-005101-36; OTHER:U1111-1177-6327; NIH:2015

Registered primary outcomes

Change From Baseline in HbA1c to Week 24 [Baseline, Week 24]

Linked records (5)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0038364	146-OR: Differences in HbA1c-Lowering Effect and Hypoglycemia Risk between Gla-300 and IDeg According to Renal Function in the BRIGHT Trial Martin Haluzı́k, Diabetes	2019	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02738151
R0052511	Niedrigere Hypoglykämie-Raten mit Insulin glargin 300 E/ml vs. Insulin degludec 100 E/ml bei insulinnaiven erwachsenen Typ-2-Diabetespatienten: die randomisierte BRIGHT-Studie GB Bolli, Diabetologie und Stoffwechsel	2019	Other	DOI	cites ClinicalTrials.gov:NCT02738151
R0048720	Impact of Background Antihyperglycemic Therapy on Insulin Glargine 300 U/mL (Gla-300) vs. Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve People with T2DM from the BRIGHT Randomized Study Ronan Roussel, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02738151
R0051324	Similar Glycemic Control and Less or Comparable Hypoglycemia with Insulin Glargine 300 U/mL (Gla-300) vs. Degludec 100 U/mL (IDeg-100) in Insulin-Naïve T2DM on Antihyperglycemic Drugs ± GLP-1 RAs—The BRIGHT Randomized Study ALICE Y.Y. CHENG, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02738151
R0052642	Lower Hypoglycemia Rates with Insulin Glargine 300 U/mL (Gla-300) vs. Insulin Degludec 100 U/mL (IDeg-100) in Insulin-Naïve Adults with T2DM on Oral Antihyperglycemic Therapy ± GLP-1RA—The BRIGHT Randomized Study Geremia B. Bolli, Diabetes	2018	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02738151