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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)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin glargine, 300U/mL
Insulin degludec, 100 U/mL
Non-insulin anti-diabetic treatment
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational Site Number 840038
  • Investigational Site Number 840066
  • Investigational Site Number 840051
  • Investigational Site Number 840081
  • Investigational Site Number 840016
  • Investigational Site Number 840002
  • Investigational Site Number 840091
  • Investigational Site Number 840058
  • Investigational Site Number 840021
  • Investigational Site Number 840087
  • Investigational Site Number 840030
  • Investigational Site Number 840065
  • Investigational Site Number 840075
  • Investigational Site Number 840076
  • Investigational Site Number 840026
  • Investigational Site Number 840052
  • Investigational Site Number 840080
  • Investigational Site Number 840018
  • Investigational Site Number 840071
  • Investigational Site Number 840085
  • Investigational Site Number 840072
  • Investigational Site Number 840039
  • Investigational Site Number 840036
  • Investigational Site Number 840010
  • Investigational Site Number 840005
  • Investigational Site Number 840063
  • Investigational Site Number 840098
  • Investigational Site Number 840101
  • Investigational Site Number 840096
  • Investigational Site Number 840061
  • Investigational Site Number 840011
  • Investigational Site Number 840001
  • Investigational Site Number 840041
  • Investigational Site Number 840057
  • Investigational Site Number 840033
  • Investigational Site Number 840084
  • Investigational Site Number 840048
  • Investigational Site Number 840023
  • Investigational Site Number 840045
  • Investigational Site Number 840031
  • Investigational Site Number 840060
  • Investigational Site Number 840064
  • Investigational Site Number 840043
  • Investigational Site Number 840082
  • Investigational Site Number 840025
  • Investigational Site Number 840022
  • Investigational Site Number 840029
  • Investigational Site Number 840056
  • Investigational Site Number 840093
  • Investigational Site Number 840097
  • Investigational Site Number 840070
  • Investigational Site Number 840044
  • Investigational Site Number 840069
  • Investigational Site Number 840079
  • Investigational Site Number 840006
  • Investigational Site Number 840088
  • Investigational Site Number 840077
  • Investigational Site Number 840007
  • Investigational Site Number 840086
  • Investigational Site Number 840027
  • Investigational Site Number 840004
  • Investigational Site Number 840040
  • Investigational Site Number 840046
  • Investigational Site Number 840054
  • Investigational Site Number 840017
  • Investigational Site Number 840008
  • Investigational Site Number 840094
  • Investigational Site Number 840009
  • Investigational Site Number 840053
  • Investigational Site Number 840095
  • Investigational Site Number 840032
  • Investigational Site Number 840024
  • Investigational Site Number 840020
  • Investigational Site Number 840012
  • Investigational Site Number 100001
  • Investigational Site Number 100002
  • Investigational Site Number 100003
  • Investigational Site Number 191001
  • Investigational Site Number 191002
  • Investigational Site Number 191003
  • Investigational Site Number 203009
  • Investigational Site Number 203006
  • Investigational Site Number 203005
  • Investigational Site Number 203001
  • Investigational Site Number 203007
  • Investigational Site Number 203008
  • Investigational Site Number 203002
  • Investigational Site Number 203004
  • Investigational Site Number 208003
  • Investigational Site Number 208002
  • Investigational Site Number 208001
  • Investigational Site Number 208004
  • Investigational Site Number 250002
  • Investigational Site Number 250003
  • Investigational Site Number 250001
  • Investigational Site Number 250006
  • Investigational Site Number 250005
  • Investigational Site Number 250007
  • Investigational Site Number 300005
  • Investigational Site Number 300001
  • Investigational Site Number 300002
  • Investigational Site Number 300003
  • Investigational Site Number 348004
  • Investigational Site Number 348002
  • Investigational Site Number 348001
  • Investigational Site Number 348003
  • Investigational Site Number 376001
  • Investigational Site Number 376004
  • Investigational Site Number 376008
  • Investigational Site Number 376009
  • Investigational Site Number 376002
  • Investigational Site Number 376006
  • Investigational Site Number 376003
  • Investigational Site Number 376007
  • Investigational Site Number 380007
  • Investigational Site Number 380009
  • Investigational Site Number 380010
  • Investigational Site Number 380014
  • Investigational Site Number 380002
  • Investigational Site Number 380011
  • Investigational Site Number 380008
  • Investigational Site Number 380015
  • Investigational Site Number 380016
  • Investigational Site Number 380013
  • Investigational Site Number 380005
  • Investigational Site Number 380012
  • Investigational Site Number 642007
  • Investigational Site Number 642008
  • Investigational Site Number 642001
  • Investigational Site Number 642013
  • Investigational Site Number 642015
  • Investigational Site Number 642003
  • Investigational Site Number 642009
  • Investigational Site Number 642014
  • Investigational Site Number 642005
  • Investigational Site Number 642012
  • Investigational Site Number 642010
  • Investigational Site Number 642004
  • Investigational Site Number 642006
  • Investigational Site Number 688001
  • Investigational Site Number 688002
  • Investigational Site Number 688003
  • Investigational Site Number 703006
  • Investigational Site Number 703002
  • Investigational Site Number 703001
  • Investigational Site Number 703003
  • Investigational Site Number 703005
  • Investigational Site Number 752102
  • Investigational Site Number 752101
  • Investigational Site Number 756003
  • Investigational Site Number 756001
  • Investigational Site Number 826001
  • Investigational Site Number 826005
  • Investigational Site Number 826008
  • Investigational Site Number 826002
  • Investigational Site Number 826009
  • Investigational Site Number 826006
  • Investigational Site Number 826004

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Toujeo

Tresiba

Arm Description

Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.

Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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%.
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.
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.
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).
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).
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).

Full Information

First Posted
March 31, 2016
Last Updated
August 14, 2018
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT02738151
Brief Title
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
Acronym
BRIGHT
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
May 19, 2016 (undefined)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
929 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toujeo
Arm Type
Experimental
Arm Description
Toujeo® (Insulin glargine, 300 U/mL) subcutaneous (SC) injection once daily up to Week 24 on top of non-insulin antidiabetic treatment.
Arm Title
Tresiba
Arm Type
Active Comparator
Arm Description
Tresiba® (Insulin Degludec, 100 U/mL) SC injection once daily up to Week 24 on top of non-insulin antidiabetic treatment .
Intervention Type
Drug
Intervention Name(s)
Insulin glargine, 300U/mL
Other Intervention Name(s)
HOE901-U300, Toujeo
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Insulin degludec, 100 U/mL
Other Intervention Name(s)
Tresiba
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Non-insulin anti-diabetic treatment
Intervention Description
Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
Primary Outcome Measure Information:
Title
Change From Baseline in HbA1c to Week 24
Description
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.
Time Frame
Baseline, Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c to Week 12
Description
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.
Time Frame
Baseline, Week 12
Title
Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in Fasting Self-Monitoring Plasma Glucose (SMPG) to Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in 8 Point SMPG Profile to Week 12 and Week 24 Per Time Point
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in 4-point SMPG Profile to Week 12 and Week 24 Per Time Point
Description
4-point SMPG profiles were measured at the following 4 points: prebreakfast, prelunch, predinner and bedtime.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in 24-hour Average 8-point SMPG Profile to Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in Variability of Fasting SMPG to Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24
Title
Change From Baseline in Variability of 24-Hour 8-Point SMPG Profiles at Week 12 and Week 24
Description
Adjusted LS means were obtained from MMRM.
Time Frame
Baseline, Week 12 and Week 24
Title
Percentage of Participants Reaching Target HbA1c of < 7% and =<6.5% at Week 12 and Week 24
Description
Only the post-baseline HbA1c measurements before rescue and during the 12 week and 24-week on-treatment period were considered in the analysis.
Time Frame
Week 12, and Week 24
Title
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
Description
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).
Time Frame
Week 12, and Week 24
Title
Percentage of Participants With Sulphonylurea or Meglitinide Dose Reduction/ Discontinuation Due to Hypoglycemia During 24 Weeks Treatment Period
Description
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.
Time Frame
Baseline to Week 24
Title
Percentage of Participants Requiring a Rescue Therapy During 24 Weeks Treatment Period
Description
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%.
Time Frame
Baseline to Week 24
Title
Change From Baseline in Basal Insulin Dose (U/kg Body Weight) to Week 12 and Week 24
Description
Only the insulin dose measurements performed before initiation of rescue therapy and during the on-treatment period were considered in the analysis.
Time Frame
Baseline, Week 12 and Week 24
Title
Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) by Study Period
Description
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.
Time Frame
Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Title
Percentage of Participants With At Least One Hypoglycemic Events (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal) by Study Period
Description
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).
Time Frame
Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Title
Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Any Time of the Day) Event Rate Per Participant Year During Study Period
Description
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).
Time Frame
Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Title
Hypoglycemia (Any, Severe and/or Confirmed Hypoglycemia: Nocturnal ) Event Rate Per Participant Year During Study Period
Description
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).
Time Frame
Day 1-Week 12, Week 13-Week 24, and 24 Week Period
Other Pre-specified Outcome Measures:
Title
Change From Baseline in Total Diabetes Treatment Satisfaction Questionnaire (DTSQ) Status at Week 12 and Week 24
Description
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.
Time Frame
Baseline, Week 12 and Week 24

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
30104294
Citation
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.
Results Reference
derived

Learn more about this trial

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

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