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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002756-91 | EudraCT Number | ||
| U1111-1197-8171 | Other Identifier | UTN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toujeo | Experimental | Toujeo (Insulin Glargine, 300 U/ml) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog. |
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| Tresiba | Active Comparator | Tresiba (Insulin Degludec, 100U/ml) SC injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin glargine, 300 U/ml | Drug | Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | During Week 10 up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria :
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Sciences & Operations | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States | Dallas | Texas | 75000 | United States | ||
| Investigational site BRAZIL |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32100192 | Derived | Battelino T, Bosnyak Z, Danne T, Mukherjee B, Edelman S, Pilorget V, Choudhary P, Renard E, Bergenstal R. InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design. Diabetes Ther. 2020 Apr;11(4):1017-1027. doi: 10.1007/s13300-020-00781-6. Epub 2020 Feb 25. |
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Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Toujeo | Toujeo (Insulin Glargine, 300 units per milliliter [U/ml]) subcutaneous (SC) injection, once daily in the morning before breakfast for 12 weeks on top of rapid acting insulin analog. |
| FG001 | Tresiba |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2019 | Sep 13, 2022 |
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| Insulin degludec, 100U/ml | Drug | Pharmaceutical form: solution for injection in a prefilled pen Route of administration: SC injection |
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| Background therapy: Rapid acting insulin analogs | Drug | Route of administration: SC injection |
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| During Week 10 up to Week 12 |
| 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. | During Week 10 up to Week 12 |
| 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. | During Week 10 up to Week 12 |
| 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. | Baseline, Week 12 |
| 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. | Baseline, Week 12 |
| 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. | During Week 10 up to Week 12 |
| 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. | During Week 10 up to Week 12 |
| 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. | During Week 10 up to Week 12 |
| 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. | During Week 10 up to Week 12 |
| 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. | From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) |
| 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. | From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) |
| Brazil |
| Brazil |
| Investigational site Germany | Germany | Germany |
| Investigational site Hungary | Hungary | Hungary |
| Investigational site Netherlands | Netherlands | Netherlands |
| Investigational site Turkey | Turkey | Turkey (Türkiye) |
| Investigational site United Kingdom | United Kingdom | United Kingdom |
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.
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| NOT COMPLETED |
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Analysis was performed on intent-to-treat (ITT) population which included all randomized participants (who signed the informed consent form and were allocated to a treatment group before the first investigational medicinal product [IMP] administration and recorded in the IRT database), irrespective of the treatment actually received and were analyzed according to the treatment group allocated by randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of time | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of total CV | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of time | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of CV | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter | Baseline, Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of time | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | hours per day | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | percentage of time | During Week 10 up to Week 12 |
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| 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. | Analysis was performed on ITT population. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | hours per day | During Week 10 up to Week 12 |
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| 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. | 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. | Posted | Count of Participants | Participants | From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) |
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| 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. | Analysis was performed on safety population. | Posted | Number | events per participant-year | From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days) |
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From the first injection of IMP up to 2 days after the last injection of IMP (i.e., up to 86 days)
Reported AEs were TEAEs that developed/worsened or became serious during on-treatment period (defined as the time from the first injection of IMP to the last injection of IMP + 2 days). Analysis was performed on safety population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Toujeo | Toujeo (Insulin Glargine, 300 U/ml) SC injection, before meals once daily in the morning for 12 weeks on top of rapid acting insulin analog. | 0 | 172 | 7 | 172 | 0 | 172 |
| EG001 | Tresiba | Tresiba (Insulin Degludec, 100 U/ml) SC injection, before meals once daily in the morning for 12 weeks on top of rapid acting insulin analog. | 0 | 171 | 8 | 171 | 0 | 171 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoglycaemic Seizure | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Hypoglycaemic Unconsciousness | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Orthostatic Intolerance | Nervous system disorders | MedDRA 24.0 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA 24.0 | Systematic Assessment |
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| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 24.0 | Systematic Assessment |
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The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | Sanofi aventis recherche & développement | 800-633-1610 | 6# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 1, 2021 | Sep 13, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C571886 | insulin degludec |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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Non-inferiority was based on a relative margin of 10%. Since higher time in range means better outcome, non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference between Toujeo LS mean and 90% of Tresiba LS mean at Week 12 was > 0. |
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