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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1197-7811 | Other Identifier | UTN | |
| 136342 | Other Identifier | IND |
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Primary Objective:
To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
The study duration per participant was less than 19 weeks (for participants who did not require the run-in period) and less than 31 weeks (for participants who require the run-in period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switching: NovoLog/SAR341402 | Experimental | Participants self-administered subcutaneous (SC) injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 units per milliliters [U/mL]) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
|
| Non-Switching: NovoLog | Active Comparator | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart SAR341402 | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog. | 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112 |
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog. | 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2 hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 |
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog. | 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs) | AIA was categorized as: treatment-induced AIA, treatment-boosted AIA, and treatment-emergent AIA. Treatment-induced AIAs: participants who developed AIA following investigational medicinal product (IMP) administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing Baseline sample). Treatment-boosted AIAs: participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to Baseline value at any time during on-treatment period, in those participants with pre-existing AIA). Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. On-treatment period was defined as the time from the first injection of IMP up to the last injection of IMP + 1 day. |
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Inclusion criteria:
Participants with T1DM.
Participants on continuous insulin treatment for at least 12 months prior to screening.
Participants exclusively on a multiple (greater than or equal to 3) daily injection insulin analogue regimen using:
Glycated hemoglobin (HbA1c) less than or equal to 10 percent (%) (85.79 millimoles per mole) at screening.
Body mass index less than or equal to 35 kilograms per meter square (kg/m^2) at screening.
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 |
|---|---|---|---|---|---|---|
| Investigational Site Number 8400014 | Concord | California | 94520 | United States | ||
| Investigational Site Number 8400001 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37880868 | Result | Shah VN, Al-Karadsheh A, Barnes C, Mandry J, Nakhle S, Wernicke-Panten K, Kramer D, Schmider W, Pierre S, Teichert L, Rotthaeuser B, Mukherjee B, Bailey TS. Pharmacokinetic similarity of switching SAR341402 insulin aspart biosimilar and NovoLog insulin aspart versus continuous use of NovoLog in adults with type 1 diabetes: The GEMELLI X trial. Diabetes Obes Metab. 2024 Feb;26(2):540-547. doi: 10.1111/dom.15341. Epub 2023 Oct 25. | |
| 38420944 |
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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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Participants not treated with NovoLog and insulin glargine (100 units per milliliter [U/mL] for at least 12 weeks prior to screening, completed a mandatory run-in period of up to 12-weeks and were administered NovoLog and Lantus. Run-in period duration was considered as a sufficient duration to ensure that, at the time of randomization, all the participants had received NovoLog and insulin glargine (100 U/mL) for at least 12 weeks.
Study was conducted at 31 active sites in the United States. A total of 279 participants were screened from 11 March 2019 to 30 Oct 2019, out of which 210 participants were randomized. Participants were randomized in 1:1 ratio to "switching arm" (NovoLog/SAR341402) and "non-switching arm" (NovoLog). Randomization was stratified by glycated hemoglobin A1c (HbA1c) (less than [<] 8.0 percent [%] and greater than or equal to [>=] 8.0%) obtained at screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | Switching: NovoLog/SAR341402 | Participants self-administered subcutaneous (SC) injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 U/mL) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
| 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 | Aug 13, 2019 | Jun 28, 2023 |
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| Insulin Aspart | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
|
| Insulin glargine U100 | Drug | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous |
|
|
| From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
| Number of Participants With at Least One Hypoglycemic Event | Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant was not capable of helping self. Documented symptomatic hypoglycemia: event in which typical symptoms of hypoglycemia (SOH) were accompanied by measured plasma glucose concentration (PGC) less than or equal to (<=) 3.9 millimoles per liter (mmol/L)(<70 milligrams per deciliter [mg/dL]) or <3.0 mmol/L(<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and with measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L (<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC <=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC greater than (>) 3.9 mmol/L (70 mg/dL). | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
| Number of Hypoglycemic Events Per Participant-year | Number of hypoglycemia events (any, severe, documented [both threshold], asymptomatic [both threshold], probable symptomatic and relative) per participant-year of exposure were reported. Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant wasn't capable of helping self. Documented symptomatic hypoglycemia: event in which typical SOH were accompanied by measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L(<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L(<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC <=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC >3.9 mmol/L (70 mg/dL). | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the on-treatment period (from first injection of IMP up to 1 day after the last injection of IMP). | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
| Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | Tmax was defined as the time taken to reach the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog. | 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 |
| Temecula |
| California |
| 92591 |
| United States |
| Investigational Site Number 8400015 | Ventura | California | 93003 | United States |
| Investigational Site Number 8400010 | Aurora | Colorado | 80045 | United States |
| Investigational Site Number 8400029 | Waterbury | Connecticut | 06708-3346 | United States |
| Investigational Site Number 8400038 | Doral | Florida | 33166 | United States |
| Investigational Site Number 8400030 | Miami | Florida | 33165 | United States |
| Investigational Site Number 8400032 | New Port Richey | Florida | 34652 | United States |
| Investigational Site Number 8400026 | Ocoee | Florida | 34761 | United States |
| Investigational Site Number 8400033 | Palm Harbor | Florida | 34684 | United States |
| Investigational Site Number 8400012 | Atlanta | Georgia | 30318 | United States |
| Investigational Site Number 8400005 | Columbus | Georgia | 31904 | United States |
| Investigational Site Number 8400009 | Roswell | Georgia | 30076 | United States |
| Investigational Site Number 8400019 | Crystal Lake | Illinois | 60012 | United States |
| Investigational Site Number 8400028 | Des Moines | Iowa | 50314 | United States |
| Investigational Site Number 8400018 | Lexington | Kentucky | 40503 | United States |
| Investigational Site Number 8400023 | Baltimore | Maryland | 21237 | United States |
| Investigational Site Number 8400003 | Rockville | Maryland | 20852-4267 | United States |
| Investigational Site Number 8400013 | Waltham | Massachusetts | 02453 | United States |
| Investigational Site Number 8400004 | Flint | Michigan | 48532 | United States |
| Investigational Site Number 8400021 | Kansas City | Missouri | 64111 | United States |
| Investigational Site Number 8400031 | Washington | Missouri | 63090 | United States |
| Investigational Site Number 8400036 | Omaha | Nebraska | 68114 | United States |
| Investigational Site Number 8400017 | Las Vegas | Nevada | 89148 | United States |
| Investigational Site Number 8400007 | New York | New York | 10001 | United States |
| Investigational Site Number 8400006 | Morehead City | North Carolina | 28557 | United States |
| Investigational Site Number 8400035 | Rocky Mount | North Carolina | 27804 | United States |
| Investigational Site Number 8400034 | Jefferson City | Tennessee | 37760 | United States |
| Investigational Site Number 8400040 | Dallas | Texas | 75235 | United States |
| Investigational Site Number 8400042 | El Paso | Texas | 79935 | United States |
| Investigational Site Number 8400027 | Houston | Texas | 77079 | United States |
| Investigational Site Number 8400016 | Mesquite | Texas | 75149 | United States |
| Investigational Site Number 8400041 | Waco | Texas | 76710 | United States |
| Result |
| Shah VN, Al-Karadsheh A, Barnes C, Mandry J, Nakhle S, Wernicke-Panten K, Kramer D, Schmider W, Pierre S, Teichert L, Rotthaeuser B, Mukherjee B, Bailey TS. Safety and Efficacy of Switching SAR341402 Insulin Aspart and Originator Insulin Aspart vs Continuous Use of Originator Insulin Aspart in Adults With Type 1 Diabetes: The GEMELLI X Trial. J Diabetes Sci Technol. 2025 Jul;19(4):1051-1059. doi: 10.1177/19322968241232709. Epub 2024 Feb 29. |
| FG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
| Treated |
|
| Safety Population | Safety population included all randomized participants who received at least one dose of investigational medicinal product (IMP) and analyzed according to the treatment actually received. |
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| Anti-insulin Antibody (AIA) Population | AIA population included all participants who received at least one dose of IMP and with at least one AIA sample available for analysis, and were analyzed according to the treatment actually received |
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| COMPLETED |
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| NOT COMPLETED |
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Analysis was performed on randomized population which included all participants who had a treatment kit number allocated and recorded in the interactive response technology (IRT) database, regardless of whether the treatment kit was used.
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| ID | Title | Description |
|---|---|---|
| BG000 | Switching: NovoLog/SAR341402 | Participants self-administered SC injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 U/mL) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
| BG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
| 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 (NIH/OMB) | 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 | Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog. | Analysis was performed on PK population which included all randomized participants without deviation that could significantly impact the PK analysis and for whom PK data were considered sufficient and interpretable. | Posted | Mean | Standard Deviation | picograms*hour per milliliter (pg*h/mL) | 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112 |
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| Primary | Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog. | Analysis was performed on PK population. Here, "overall number of participants analyzed" = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | pg*h/mL | 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2 hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 |
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| Primary | Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog. | Analysis was performed on PK population. | Posted | Mean | Standard Deviation | picograms per milliliter (pg/mL) | 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 |
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| Secondary | Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs) | AIA was categorized as: treatment-induced AIA, treatment-boosted AIA, and treatment-emergent AIA. Treatment-induced AIAs: participants who developed AIA following investigational medicinal product (IMP) administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing Baseline sample). Treatment-boosted AIAs: participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to Baseline value at any time during on-treatment period, in those participants with pre-existing AIA). Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. On-treatment period was defined as the time from the first injection of IMP up to the last injection of IMP + 1 day. | Analyzed on AIA population which included all randomized participants who received at least one dose of IMP and with at least one AIA sample available for analysis and were analyzed according to treatment actually received. Here, "number analyzed" = participants with available data for each specified category. Five participants randomized to switching arm discontinued IMP during first treatment of NovoLog before switching to SAR341402, thus included in non-switching arm for the AIA evaluations. | Posted | Count of Participants | Participants | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
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| Secondary | Number of Participants With at Least One Hypoglycemic Event | Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant was not capable of helping self. Documented symptomatic hypoglycemia: event in which typical symptoms of hypoglycemia (SOH) were accompanied by measured plasma glucose concentration (PGC) less than or equal to (<=) 3.9 millimoles per liter (mmol/L)(<70 milligrams per deciliter [mg/dL]) or <3.0 mmol/L(<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and with measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L (<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC <=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC greater than (>) 3.9 mmol/L (70 mg/dL). | Analysis was performed on safety population which included all randomized participants who received at least one dose of IMP and analyzed according to the treatment actually received. Five participants randomized to switching arm discontinued IMP during the first treatment of NovoLog before switching to SAR341402, thus included in the non-switching arm for the safety analysis. | Posted | Count of Participants | Participants | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
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| Secondary | Number of Hypoglycemic Events Per Participant-year | Number of hypoglycemia events (any, severe, documented [both threshold], asymptomatic [both threshold], probable symptomatic and relative) per participant-year of exposure were reported. Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant wasn't capable of helping self. Documented symptomatic hypoglycemia: event in which typical SOH were accompanied by measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L(<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and measured PGC of <=3.9 mmol/L (<70 mg/dL) or <3.0 mmol/L(<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC <=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC >3.9 mmol/L (70 mg/dL). | Analysis was performed on safety population. Five participants randomized to switching arm discontinued IMP during the first treatment of NovoLog before switching to SAR341402, thus included in the non-switching arm for the safety analysis. | Posted | Number | events per participant-year | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
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| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the on-treatment period (from first injection of IMP up to 1 day after the last injection of IMP). | Analysis was performed on safety population. Five participants randomized to switching arm discontinued IMP during the first treatment of NovoLog before switching to SAR341402, thus included in the non-switching arm for the safety analysis. | Posted | Count of Participants | Participants | From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113) |
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| Secondary | Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | Tmax was defined as the time taken to reach the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog. | Analysis was performed on PK population. | Posted | Median | Full Range | hours | 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 |
|
From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)
Analysis was performed on safety population. Five participants randomized to switching arm discontinued IMP during the first treatment of NovoLog before switching to SAR341402, thus included in the non-switching arm for the safety analysis.
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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 | Switching: NovoLog/SAR341402 | Participants self-administered SC injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 U/mL) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. | 0 | 99 | 5 | 99 | 3 | 99 |
| EG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. | 0 | 111 | 5 | 111 | 12 | 111 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis Viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alcohol Abuse | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 23.0 | 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 24, 2020 | Jun 28, 2023 | SAP_001.pdf |
| 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D000069036 | Insulin Glargine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-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 |
| D049528 | Insulin, Long-Acting |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants self-administered SC injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 U/mL) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin.
| OG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
|
|
| OG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
|
|
| OG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
|
|
| OG001 | Non-switching: NovoLog | Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin. |
|
|
|
|