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AzTrials

Diabetes Mellitus, Type 2Phase 4BRIGHTNCT02738151

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 Phase 4 study testing Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL and Non-insulin anti-diabetic treatment in people with Diabetes Mellitus, Type 2, run by Sanofi at 158 sites in 16 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL and Non-insulin anti-diabetic treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
929 participants
Where
158 sitesin 16 countries
Study dates
19 May 2016to 15 Aug 2017
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.

Trial locations and contacts

158 sites in 16 countries.

158 sites in 16 countries

United States74 sites

  • Investigational Site Number 840051

    Anaheim, California, 92801

  • Investigational Site Number 840093

    Anderson, South Carolina, 29621

  • Investigational Site Number 840036

    Arlington Heights, Illinois, 60005

  • Investigational Site Number 840005

    Avon, Indiana, 46123

  • Investigational Site Number 840029

    Beaver, Pennsylvania, 15009

  • Investigational Site Number 840075

    Bradenton, Florida, 34201

  • Investigational Site Number 840079

    Bristol, Tennessee

  • Investigational Site Number 840006

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840048

    Chesterfield, Missouri, 63017

  • Investigational Site Number 840010

    Chicago, Illinois, 60616

  • Investigational Site Number 840081

    Chino, California, 91710

  • Investigational Site Number 840063

    Council Bluffs, Iowa, 51501

  • Investigational Site Number 840007

    Dallas, Texas, 75230

  • Investigational Site Number 840086

    Dallas, Texas, 75231

  • Investigational Site Number 840098

    Des Moines, Iowa, 50134

  • Investigational Site Number 840101

    Des Moines, Iowa, 50314

  • Investigational Site Number 840056

    Downingtown, Pennsylvania, 19335

  • Investigational Site Number 840041

    Flint, Michigan, 48504

  • Investigational Site Number 840057

    Flint, Michigan, 48532

  • Investigational Site Number 840097

    Greenville, South Carolina, 29605

  • Investigational Site Number 840070

    Greer, South Carolina, 29651

  • Investigational Site Number 840060

    Hickory, North Carolina, 28601

  • Investigational Site Number 840027

    Houston, Texas, 77061

  • Investigational Site Number 840004

    Houston, Texas, 77083-4436

  • Investigational Site Number 840040

    Houston, Texas, 77090

  • Investigational Site Number 840046

    Houston, Texas, 77095

  • Investigational Site Number 840016

    Huntington Park, California, 90255

  • Investigational Site Number 840054

    Hurst, Texas, 76054

  • Investigational Site Number 840011

    Hyattsville, Maryland, 20782

  • Investigational Site Number 840088

    Knoxville, Tennessee, 37912

  • Investigational Site Number 840002

    La Jolla, California, 92037

  • Investigational Site Number 840023

    Las Vegas, Nevada, 89117

  • Investigational Site Number 840045

    Las Vegas, Nevada, 89128

  • Investigational Site Number 840071

    Lawrenceville, Georgia, 30046

  • Investigational Site Number 840031

    Linden, New Jersey, 07036

  • Investigational Site Number 840091

    Los Angeles, California, 90017

  • Investigational Site Number 840017

    Mesquite, Texas, 75149

  • Investigational Site Number 840008

    Missouri City, Texas, 77459

  • Investigational Site Number 840064

    Morganton, North Carolina, 28655

  • Investigational Site Number 840076

    New Port Richey, Florida, 34652

  • Investigational Site Number 840077

    New Tazewell, Tennessee, 37825

  • Investigational Site Number 840024

    Norfolk, Virginia

  • Investigational Site Number 840044

    North Myrtle Beach, South Carolina, 29582

  • Investigational Site Number 840058

    Northridge, California, 91324

  • Investigational Site Number 840026

    Ocoee, Florida, 34761

  • Investigational Site Number 840095

    Ogden, Utah, 84405

  • Investigational Site Number 840025

    Oklahoma City, Oklahoma, 73104

  • Investigational Site Number 840022

    Oklahoma City, Oklahoma, 73112

  • Investigational Site Number 840084

    Olive Branch, Mississippi, 38654

  • Investigational Site Number 840052

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840080

    Palm Harbor, Florida, 34684

  • Investigational Site Number 840021

    Palm Springs, California, 92262

  • Investigational Site Number 840061

    Paris, Kentucky, 40361

  • Investigational Site Number 840066

    Phoenix, Arizona, 85020

  • Investigational Site Number 840018

    Port Charlotte, Florida, 33952

  • Investigational Site Number 840012

    Renton, Washington, 98055

  • Investigational Site Number 840020

    Richmond, Virginia, 23219

  • Investigational Site Number 840001

    Rockville, Maryland, 20852

  • Investigational Site Number 840085

    Roswell, Georgia, 30076

  • Investigational Site Number 840032

    Salt Lake City, Utah, 84102

  • Investigational Site Number 840094

    San Antonio, Texas, 78229-3907

  • Investigational Site Number 840087

    Santa Ana, California, 92704

  • Investigational Site Number 840038

    Sheffield, Alabama, 35660

  • Investigational Site Number 840069

    Simpsonville, South Carolina, 29681

  • Investigational Site Number 840072

    Statesboro, Georgia, 30461

  • Investigational Site Number 840039

    Stockbridge, Georgia, 30281

  • Investigational Site Number 840009

    Sugar Land, Texas, 77478

  • Investigational Site Number 840030

    Torrance, California, 90505

  • Investigational Site Number 840033

    Troy, Michigan, 48085

  • Investigational Site Number 840065

    Van Nuys, California, 91405

  • Investigational Site Number 840053

    Waco, Texas, 76710

  • Investigational Site Number 840096

    West Des Moines, Iowa, 50266

  • Investigational Site Number 840043

    Wilmington, North Carolina, 28401

  • Investigational Site Number 840082

    Winston-Salem, North Carolina, 27103

Other trials in United States

Romania13 sites

  • Investigational Site Number 642007

    Brasov, 500097

  • Investigational Site Number 642008

    Brasov, 500326

  • Investigational Site Number 642001

    Bucharest, 022441

  • Investigational Site Number 642013

    Bucharest, 040172

  • Investigational Site Number 642015

    Bucharest

  • Investigational Site Number 642003

    Cluj-Napoca, 400006

  • Investigational Site Number 642009

    Constanța, 900675

  • Investigational Site Number 642014

    Iași, 700547

  • Investigational Site Number 642005

    Oradea

  • Investigational Site Number 642012

    Oradea

  • Investigational Site Number 642010

    Târgu Mureş, 540015

  • Investigational Site Number 642004

    Târgu Mureş, 540142

  • Investigational Site Number 642006

    Târgu Mureş

Other trials in Romania

Italy12 sites

  • Investigational Site Number 380007

    Bari, 70124

  • Investigational Site Number 380009

    Catanzaro

  • Investigational Site Number 380010

    Chieti, 66013

  • Investigational Site Number 380014

    Milan, 20132

  • Investigational Site Number 380002

    Moncalieri, 10024

  • Investigational Site Number 380011

    Naples, 80131

  • Investigational Site Number 380008

    Roma

  • Investigational Site Number 380015

    Roma

  • Investigational Site Number 380016

    Roma

  • Investigational Site Number 380013

    Sesto San Giovanni, 20099

  • Investigational Site Number 380005

    Torino, 10126

  • Investigational Site Number 380012

    Verona, 37126

Other trials in Italy

Czechia8 sites

  • Investigational Site Number 203009

    Hlučín

  • Investigational Site Number 203006

    Jílové u Prahy, 25401

  • Investigational Site Number 203005

    Liberec, 46001

  • Investigational Site Number 203001

    Pardubice, 53002

  • Investigational Site Number 203007

    Prague, 11000

  • Investigational Site Number 203008

    Prague, 12808

  • Investigational Site Number 203002

    Prague, 18100

  • Investigational Site Number 203004

    Vsetín, 75501

Other trials in Czechia

Israel8 sites

  • Investigational Site Number 376001

    Haifa, 31096

  • Investigational Site Number 376004

    Haifa

  • Investigational Site Number 376008

    Haifa

  • Investigational Site Number 376009

    Kfar Saba

  • Investigational Site Number 376002

    Petah Tikva

  • Investigational Site Number 376006

    Tel Aviv

  • Investigational Site Number 376007

    Tel Aviv

  • Investigational Site Number 376003

    Tel HaShomer, 52621

Other trials in Israel

United Kingdom7 sites

  • Investigational Site Number 826001

    Chertsey, KT160PZ

  • Investigational Site Number 826005

    Gillingham, ME75NY

  • Investigational Site Number 826008

    Lincoln, LN25QY

  • Investigational Site Number 826002

    London, SW109NH

  • Investigational Site Number 826009

    Manchester, M415SL

  • Investigational Site Number 826006

    Margate, CT94ANA

  • Investigational Site Number 826004

    Swansea, SA66NL

Other trials in United Kingdom

France6 sites

  • Investigational Site Number 250002

    La Roche-sur-Yon, 85025

  • Investigational Site Number 250003

    La Rochelle, 17019

  • Investigational Site Number 250001

    Nantes, 44093

  • Investigational Site Number 250006

    Nîmes, 30029

  • Investigational Site Number 250005

    Poitiers, 86021

  • Investigational Site Number 250007

    Vénissieux, 69200

Other trials in France

Slovakia5 sites

  • Investigational Site Number 703006

    Košice, 04013

  • Investigational Site Number 703002

    Ľubochňa, 03491

  • Investigational Site Number 703001

    Moldava nad Bodvou, 04525

  • Investigational Site Number 703003

    Sabinov, 08301

  • Investigational Site Number 703005

    Trebišov, 07501

Other trials in Slovakia

Denmark4 sites

  • Investigational Site Number 208003

    Aarhus, 8000

  • Investigational Site Number 208002

    Hillerød, 3400

  • Investigational Site Number 208001

    København NV, 2400

  • Investigational Site Number 208004

    Odense, 5000

Other trials in Denmark

Greece4 sites

  • Investigational Site Number 300005

    Alexandroupoli, 68100

  • Investigational Site Number 300001

    Athens, 17562

  • Investigational Site Number 300002

    Athens

  • Investigational Site Number 300003

    Athens

Other trials in Greece

Hungary4 sites

  • Investigational Site Number 348004

    Budapest, 1042

  • Investigational Site Number 348002

    Budapest, 1083

  • Investigational Site Number 348001

    Budapest, 1106

  • Investigational Site Number 348003

    Gyöngyös, 3200

Other trials in Hungary

Bulgaria3 sites

  • Investigational Site Number 100001

    Sofia, 1431

  • Investigational Site Number 100002

    Sofia, 1505

  • Investigational Site Number 100003

    Sofia

Other trials in Bulgaria

Croatia3 sites

  • Investigational Site Number 191001

    Rijeka, 51000

  • Investigational Site Number 191002

    Rijeka, 51000

  • Investigational Site Number 191003

    Zagreb

Other trials in Croatia

Serbia3 sites

  • Investigational Site Number 688001

    Belgrade, 11000

  • Investigational Site Number 688002

    Niš

  • Investigational Site Number 688003

    Niš

Other trials in Serbia

Sweden2 sites

  • Investigational Site Number 752102

    Lund, 22241

  • Investigational Site Number 752101

    Skövde, 54150

Other trials in Sweden

Switzerland2 sites

  • Investigational Site Number 756003

    Olten, 4600

  • Investigational Site Number 756001

    Sankt Gallen, 9016

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL, Non-insulin anti-diabetic treatment
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glargine, 300U/mLDrug

    Also called HOE901-U300, Toujeo

    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/mLDrug

    Also called Tresiba

    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 treatmentDrug

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

Study groups in NCT02738151
Study groupRoleWhat they receive
ToujeoExperimentalToujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
Receives: Drug: Insulin glargine, 300U/mL; Drug: Non-insulin anti-diabetic treatment
TresibaActive comparatorTresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .
Receives: Drug: Insulin degludec, 100 U/mL; Drug: Non-insulin anti-diabetic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Week 24

Secondary outcomes (17)

  1. 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.

    Measured: Baseline, Week 12

  2. 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.

    Measured: Baseline, Week 12 and Week 24

  3. 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.

    Measured: Baseline, Week 12 and Week 24

  4. 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.

    Measured: Baseline, Week 12 and Week 24

  5. 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.

    Measured: Baseline, Week 12 and Week 24

  6. 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.

    Measured: Baseline, Week 12 and Week 24

  7. 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.

    Measured: Baseline, Week 12 and Week 24

  8. 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.

    Measured: Baseline, Week 12 and Week 24

  9. 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.

    Measured: Week 12, and Week 24

  10. 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).

    Measured: Week 12, and Week 24

  11. 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.

    Measured: Baseline to Week 24

  12. 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%.

    Measured: Baseline to Week 24

  13. 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.

    Measured: Baseline, Week 12 and Week 24

  14. 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.

    Measured: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

  15. 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).

    Measured: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

  16. 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).

    Measured: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

  17. 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).

    Measured: Day 1-Week 12, Week 13-Week 24, and 24 Week Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study start19 May 2016
  3. Primary completion15 Aug 2017
  4. Study completion15 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
929 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738151
Sponsor's protocol ID
LPS14584
Other IDs
2015-005101-36, U1111-1177-6327, 2015
Acronym
BRIGHT
Status last verified
Aug 2018
First submitted
31 Mar 2016
Last updated
14 Sep 2018
Data monitoring committee
No

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.

    PubMed 30104294

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Insulin glargine, 300U/mL, Insulin degludec, 100 U/mL and Non-insulin anti-diabetic treatment in people with Diabetes Mellitus, Type 2, run by Sanofi at 158 sites in 16 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in United States, Romania, Italy, Czechia, Israel and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c to Week 24 (time frame: Baseline, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738151, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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