Type 1 Diabetes Mellitus
Conditions
Brief summary
Primary Objective: To demonstrate the non-inferiority of insulin glargine 300 units per milliliter (U/ml) in comparison to insulin degludec 100 U/ml on glycemic control and variability in participants with diabetes mellitus. Secondary Objective: To evaluate the glycemic control and variability parameters in each treatment group at Week 12 using Continuous Glucose Monitoring. To evaluate the safety of insulin glargine 300 U/ml in comparison to insulin degludec 100 U/ml.
Detailed description
The duration of the study per participant was around 18 weeks: 1 or 2 weeks of screening followed by a 4-week run-in period, a 12-week treatment period and a 2 to 4 days follow-up period.
Interventions
Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection
DRUGInsulin degludec, 100U/ml
Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection
DRUGBackground therapy: Rapid acting insulin analogs
Route of administration: SC injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
: * Participants with Type 1 Diabetes mellitus. * Participants treated with multiple daily injections using basal insulin analog once daily and rapid acting insulin analogs for at least one year. * HbA1c greater than or equal to (\>=) 7 percent (%) (53 millimoles per mole \[mmol/mol\]) and less than or equal to (\<=) 10% (86 mmol/mol) at screening.
Exclusion criteria
* Participants not on stable dose of basal insulin analog. * Participants having received Toujeo or Tresiba as basal insulin within 30 days prior to screening. * Participants not having used the same insulins (both basal and rapid) within 30 days prior to screening. * Participants having received basal insulin dose \>= 0.6 units per kilogram body weight within 30 days prior to screening. * Participants having received any glucose lowering drugs (including any premixed insulins, human regular insulin as mealtime insulins, any others injectable or oral), other than basal and rapid insulin analogs, within 3 months prior to screening. * End stage renal disease or on renal replacement treatment. * Retinopathy or maculopathy with one of the following treatments, either recent (within 3 months prior to screening) or planned: intravitreal injections or laser or vitrectomy surgery. * Body weight change \>=5 kilogram within 3 months prior to screening. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis | During Week 10 up to Week 12 | The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis | During Week 10 up to Week 12 | The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations during Week 10 to Week 12. |
| Glucose Within-day CV% and Between-day CV% | During Week 10 up to Week 12 | CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated within day and between days as ratio of standard deviation of glucose values to mean of glucose values. LS mean and SE were obtained from ANCOVA model including fixed categorical effects of treatment groups (TOUJEO, TRESIBA), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and as well as, the continuous fixed covariate of Baseline value. |
| Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12 | Baseline, Week 12 | Change in HbA1c at Week 12 was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba), and the continuous fixed covariate of Baseline HbA1c value. |
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | Baseline, Week 12 | Change in FPG was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba) and the randomization stratum of HbA1c at screening (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline FPG value. |
| Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | During Week 10 up to Week 12 | The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. All time represent the time between 00.00 hour to 23.59 hours and night represent the time between 00.00 hour to 05.59 hours. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value. |
| Glucose Total Coefficient of Variation (CV%) | During Week 10 up to Week 12 | CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated as ratio of standard deviation of glucose values to mean of glucose values. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value. |
| Percentage of Time With Glucose Level >180 Milligrams Per Deciliter | During Week 10 up to Week 12 | The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value. |
| Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter | During Week 10 up to Week 12 | Mean hours per day with glucose level \>180 milligrams per deciliter for the duration of Week 10 to Week 12 is reported in this outcome measure. |
| Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) | Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<3.9 millimoles per liter (mmol/L) (\<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. |
| Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) | Number of hypoglycemia events (any, severe and documented) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<3.9 mmol/L (\<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. Total participant years = The sum of the duration of exposure for all participants, expressed in participant years. |
| Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | During Week 10 up to Week 12 | All time represent the time between 00.00 hour to 23.59 hours and night represent the time between 00.00 hour to 05.59 hours. Mean hours per day with glucose level \<70 milligrams per deciliter during all time and only during night for the duration of Week 10 to Week 12 is reported in this outcome measure. |
Countries
Brazil, Germany, Hungary, Netherlands, Turkey (Türkiye), United Kingdom, United States
Participant flow
Recruitment details
The study was conducted at 40 active sites in 7 countries. A total of 550 participants were screened between 09 October 2019 and 06 May 2021, of which 343 participants were enrolled and randomized by an interactive response technology (IRT) (1:1 ratio) to receive Toujeo or Tresiba. A total of 207 participants were screen failure mainly due to not meeting eligibility criteria.
Pre-assignment details
Randomization was stratified by hemoglobin A1c (HbA1c) at screening (less than \[\<\] 8.0 percent \[%\]; greater than or equal to \[\>=\] 8.0%). Participants continued their short-acting mealtime insulin analogue (i.e., rapid insulin analogs) which they had used for at least 30 days before the screening visit and continued the same throughout the study.
Participants by arm
| Arm | Count |
|---|---|
| Toujeo Toujeo (Insulin Glargine, 300 U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog. | 172 |
| Tresiba Tresiba (Insulin Degludec, 100 U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog. | 171 |
| Total | 343 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 1 | 0 |
| Overall Study | Lost to Follow-up | 4 | 2 |
| Overall Study | Switch to insulin pump | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Toujeo | Tresiba | Total |
|---|---|---|---|
| Age, Continuous | 42.9 years STANDARD_DEVIATION 13.53 | 42.8 years STANDARD_DEVIATION 13.05 | 42.8 years STANDARD_DEVIATION 13.28 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 86 Participants | 74 Participants | 160 Participants |
| Sex: Female, Male Male | 86 Participants | 97 Participants | 183 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 172 | 0 / 171 |
| other Total, other adverse events | 0 / 172 | 0 / 171 |
| serious Total, serious adverse events | 7 / 172 | 8 / 171 |
Outcome results
Primary
Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis
The Continuous Glucose Monitoring (CGM) system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted least square (LS) means and standard error (SE) were obtained using analysis of covariance (ANCOVA) model on data obtained from the multiple imputations during Week 10 to Week 12.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis | 52.74 percentage of time | Standard Error 0.859 |
| Tresiba | Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis | 55.09 percentage of time | Standard Error 0.893 |
Comparison: Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.p-value: 0.006795% CI: [0.88, 5.44]ANCOVA
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12
Change in FPG was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba) and the randomization stratum of HbA1c at screening (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline FPG value.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | -16.05 milligrams per deciliter | Standard Error 5.455 |
| Tresiba | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12 | -34.55 milligrams per deciliter | Standard Error 5.523 |
Secondary
Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12
Change in HbA1c at Week 12 was analyzed using an ANCOVA model including the fixed categorical effects of treatment groups (Toujeo, Tresiba), and the continuous fixed covariate of Baseline HbA1c value.
Time frame: Baseline, Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12 | -0.75 percentage of HbA1c | Standard Error 0.058 |
| Tresiba | Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 12 | -0.92 percentage of HbA1c | Standard Error 0.057 |
Secondary
Glucose Total Coefficient of Variation (CV%)
CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated as ratio of standard deviation of glucose values to mean of glucose values. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Glucose Total Coefficient of Variation (CV%) | 39.91 percentage of total CV | Standard Error 0.36 |
| Tresiba | Glucose Total Coefficient of Variation (CV%) | 41.22 percentage of total CV | Standard Error 0.373 |
Comparison: A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially only when the primary endpoint demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.p-value: <0.000195% CI: [-6.5, -4.38]ANCOVA
Secondary
Glucose Within-day CV% and Between-day CV%
CV% was a measure of spread of variability relative to mean of population. For CGM glucose values, CV% was measure of glycemic variability across 20 days and calculated within day and between days as ratio of standard deviation of glucose values to mean of glucose values. LS mean and SE were obtained from ANCOVA model including fixed categorical effects of treatment groups (TOUJEO, TRESIBA), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and as well as, the continuous fixed covariate of Baseline value.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Toujeo | Glucose Within-day CV% and Between-day CV% | Within-day CV% | 33.48 percentage of CV | Standard Error 0.342 |
| Toujeo | Glucose Within-day CV% and Between-day CV% | Between-day CV% | 17.23 percentage of CV | Standard Error 0.404 |
| Tresiba | Glucose Within-day CV% and Between-day CV% | Within-day CV% | 34.37 percentage of CV | Standard Error 0.351 |
| Tresiba | Glucose Within-day CV% and Between-day CV% | Between-day CV% | 18.08 percentage of CV | Standard Error 0.415 |
Secondary
Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter
Mean hours per day with glucose level \>180 milligrams per deciliter for the duration of Week 10 to Week 12 is reported in this outcome measure.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter | 9.96 hours per day | Standard Error 0.234 |
| Tresiba | Mean Hours Per Day With Glucose Level >180 Milligrams Per Deciliter | 9.19 hours per day | Standard Error 0.24 |
Secondary
Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)
All time represent the time between 00.00 hour to 23.59 hours and night represent the time between 00.00 hour to 05.59 hours. Mean hours per day with glucose level \<70 milligrams per deciliter during all time and only during night for the duration of Week 10 to Week 12 is reported in this outcome measure.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Toujeo | Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | Night | 0.38 hours per day | Standard Error 0.031 |
| Toujeo | Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | All time | 1.33 hours per day | Standard Error 0.085 |
| Tresiba | Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | Night | 0.38 hours per day | Standard Error 0.031 |
| Tresiba | Mean Hours Per Day With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | All time | 1.56 hours per day | Standard Error 0.087 |
Secondary
Number of Hypoglycemic Events Per Participant Year During the On-treatment Period
Number of hypoglycemia events (any, severe and documented) per participant-year of exposure were reported. Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<3.9 mmol/L (\<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP. Total participant years = The sum of the duration of exposure for all participants, expressed in participant years.
Time frame: From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
Population: Analysis was performed on safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Toujeo | Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | Any hypoglycemia | 109.4 events per participant-year |
| Toujeo | Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | Severe hypoglycemia | 0.2 events per participant-year |
| Toujeo | Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | Documented symptomatic hypoglycemia | 67.1 events per participant-year |
| Tresiba | Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | Any hypoglycemia | 114.9 events per participant-year |
| Tresiba | Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | Severe hypoglycemia | 0.3 events per participant-year |
| Tresiba | Number of Hypoglycemic Events Per Participant Year During the On-treatment Period | Documented symptomatic hypoglycemia | 66.9 events per participant-year |
Secondary
Number of Participants With at Least One Hypoglycemic Event During the On-treatment 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, because the participant was not capable of helping self. Documented symptomatic hypoglycemia was an event during which typical symptoms of hypoglycemia were accompanied by a measured plasma glucose concentration of \<3.9 millimoles per liter (mmol/L) (\<70 milligrams per deciliter). On-treatment period was defined as the time from the first injection of IMP (included) up to 2 days after the last injection of IMP.
Time frame: From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
Population: Analysis was performed on safety population that included all randomized participants who had received at least one dose or part of a dose of IMP and were analyzed according to the treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Toujeo | Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | Any hypoglycemia | 165 Participants |
| Toujeo | Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | Severe hypoglycemia | 8 Participants |
| Toujeo | Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | Documented symptomatic hypoglycemia | 136 Participants |
| Tresiba | Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | Any hypoglycemia | 166 Participants |
| Tresiba | Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | Severe hypoglycemia | 10 Participants |
| Tresiba | Number of Participants With at Least One Hypoglycemic Event During the On-treatment Period | Documented symptomatic hypoglycemia | 134 Participants |
Secondary
Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations during Week 10 to Week 12.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis | 52.74 percentage of time | Standard Error 0.859 |
| Tresiba | Percentage of Time of Glucose Concentration Within the Target Range of >=70 to <=180 Milligrams Per Deciliter: Superiority Analysis | 55.09 percentage of time | Standard Error 0.893 |
Comparison: A hierarchical step-down testing procedure was used to control type I error. The hierarchical testing was then performed sequentially when the primary endpoint and the secondary endpoint of total CV demonstrated non-inferiority. Analysis was performed using ANCOVA model including the fixed categorical effect of treatment groups and randomization stratum of screening HbA1c (\<8.0%, \>=8.0%) and the continuous fixed covariate of Baseline percent time in range value.p-value: 0.054895% CI: [-4.75, 0.05]ANCOVA
Secondary
Percentage of Time With Glucose Level >180 Milligrams Per Deciliter
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Toujeo | Percentage of Time With Glucose Level >180 Milligrams Per Deciliter | 41.52 percentage of time | Standard Error 0.975 |
| Tresiba | Percentage of Time With Glucose Level >180 Milligrams Per Deciliter | 38.31 percentage of time | Standard Error 1.002 |
Secondary
Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night)
The CGM system combined frequent interstitial glucose measurements (every 5 minutes) with ability to analyze glucose levels in real time. All time represent the time between 00.00 hour to 23.59 hours and night represent the time between 00.00 hour to 05.59 hours. LS means and SE were obtained using ANCOVA model using fixed categorical effects of treatment groups (Toujeo, Tresiba), randomization stratum of screening HbA1c (\<8.0% versus \>=8.0%), and the continuous fixed covariate of Baseline value.
Time frame: During Week 10 up to Week 12
Population: Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Toujeo | Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | All time | 5.55 percentage of time | Standard Error 0.353 |
| Toujeo | Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | Night | 6.32 percentage of time | Standard Error 0.511 |
| Tresiba | Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | All time | 6.49 percentage of time | Standard Error 0.362 |
| Tresiba | Percentage of Time With Glucose Level <70 Milligrams Per Deciliter (All Time and During the Night) | Night | 6.26 percentage of time | Standard Error 0.524 |