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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000091-28 | EudraCT Number | ||
| U1111-1191-5775 | Other Identifier | UTN |
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Primary Objective:
To demonstrate non-inferiority of SAR341402 versus NovoLog/NovoRapid in glycated hemoglobin A1c (HbA1c) change from baseline to Week 26 in participants with type 1 or type 2 diabetes mellitus (T1DM or T2DM) also using Lantus®.
Secondary Objectives:
The study consisted of a 2-week screening period, a 26-week treatment period, a 26-week comparative safety extension period, and a 1-day follow-up period. The maximum study duration was 54 weeks per participant and a 1 day safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SAR341402 | Experimental | SAR341402 subcutaneous (SC), before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. |
|
| NovoLog/NovoRapid | Active Comparator | NovoLog/NovoRapid SC, before meals intake on top of QD Insulin Glargine, up to Week 52. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin aspart | Drug | SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 millimoles/liter [mmol/L] [<180 milligram/deciliter {mg/dL}]) while avoiding hypoglycemia. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 | All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c From Baseline to Week 52 | All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c at Week 26 and Week 52 was calculated by subtracting baseline value from Week 26 and Week 52 value, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae). |
Inclusion criteria :
Exclusion criteria:
At screening visit, age under legal age of adulthood.
HbA1c <7.0% or greater than (>) 10% at screening.
Less than 1 year on continuous insulin treatment.
Use of insulin pump in the last 3 months before screening visit.
Participants with incomplete baseline 7-point SMPG profile, defined as participants who do not have 7-point profiles with at least 5 points on at least 2 days in the week before randomization Visit 3.
Participants with T1DM: Use of glucose lowering agents other than insulin including use of non-insulin injectable peptides in the last 3 months prior to screening.
Participants with T2DM:
At screening visit, body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter square (kg/m^2) in participants with T1DM and >=40 kg/m^2 in participants with T2DM.
Use of insulin other than:
Status post pancreatectomy.
Status post pancreas and/or islet cell transplantation.
Hospitalization for recurrent diabetic ketoacidosis in the last 3 months before screening visit.
History of severe hypoglycemia requiring Emergency Room admission or hospitalization in the last 3 months before screening visit.
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.
Pregnant or breastfeeding women.
Women of childbearing potential not protected by highly effective method(s) of birth control.
The above information is 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 8400040 | Little Rock | Arkansas | 72211 | United States | ||
| Investigational Site Number 8400012 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31804851 | Background | Garg SK, Wernicke-Panten K, Wardecki M, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Mukherjee B, Shah VN. Efficacy and Safety of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Treated for 26 Weeks with Multiple Daily Injections in Combination with Insulin Glargine: A Randomized Open-Label Trial (GEMELLI 1). Diabetes Technol Ther. 2020 Feb;22(2):85-95. doi: 10.1089/dia.2019.0382. | |
| 32068436 |
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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 HbA1c at screening visit (<8%, greater than or equal to [>=] 8%), prior use of NovoLog/NovoRapid (Yes, No), geographical region (Europe, United States [US], Japan) and type 1 or 2 of diabetes mellitus (T1DM/T2DM [US only]). Assigned to arms in 1:1 ratio (SAR341402: NovoLog/NovoRapid).
The study was conducted at 82 centers in 7 countries. A total of 846 participants were screened between 02 August 2017 and 29 December 2017, of which 249 participants were screen failures. Screen failures were mainly due to glycated hemoglobin A1c (HbA1c) level lesser than (<) 7.0% or greater than (>) 10% at the screening visit.
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| ID | Title | Description |
|---|---|---|
| FG000 | SAR341402 | SAR341402 100 units per milliliter (U/mL) subcutaneous (SC) injection, before meals intake on top of once daily (QD) Insulin Glargine, up to Week 52. |
| FG001 | NovoLog/NovoRapid |
| 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 | Dec 13, 2017 | Jul 16, 2019 |
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|
| NovoLog/NovoRapid | Drug | NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 mmol/L [<180 mg/dL]) while avoiding hypoglycemia. |
|
|
| Insulin glargine (HOE901) | Drug | Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia. |
|
|
| Baseline, Week 52 |
| Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders. | Week 26 and Week 52 |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 | All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Baseline, Week 26, and Week 52 |
| Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52 | Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Baseline, Week 26, and Week 52 |
| Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52 | Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Baseline, Week 26, and Week 52 |
| Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point | 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit. | Baseline, Week 26, and Week 52 |
| Number of Participants With at Least One Hypoglycemic 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, 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 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). | From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Number of Hypoglycemia Events Per Participant-Year | Number of hypoglycemia events (any, severe and documented [both thresholds]) 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 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). | From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported. | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample | Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence). | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs) | AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following 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). 2) Participants with treatment-boosted AIAs were those 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). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Baseline, Week 26 and Week 52 |
| Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | 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 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during the main 6-month or 12-month on-treatment periods. | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following 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. 2) Participants with treatment-boosted AIAs were those 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). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. Data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
| Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52 | Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit. | Baseline, Day 1, Week 26 and Week 52 |
| Concord |
| California |
| 94520 |
| United States |
| Investigational Site Number 8400002 | Escondido | California | 92025 | United States |
| Investigational Site Number 8400030 | Fresno | California | 93720 | United States |
| Investigational Site Number 8400004 | Greenbrae | California | 94904 | United States |
| Investigational Site Number 8400014 | La Jolla | California | 92037 | United States |
| Investigational Site Number 8400043 | Los Angeles | California | 90057 | United States |
| Investigational Site Number 8400036 | Pomona | California | 91766 | United States |
| Investigational Site Number 8400011 | Santa Barbara | California | 93105 | United States |
| Investigational Site Number 8400013 | Ventura | California | 93003 | United States |
| Investigational Site Number 8400037 | Aurora | Colorado | 80045 | United States |
| Investigational Site Number 8400018 | Englewood | Colorado | 80113 | United States |
| Investigational Site Number 8400031 | New Port Richey | Florida | 34652 | United States |
| Investigational Site Number 8400027 | Ocoee | Florida | 34761 | United States |
| Investigational Site Number 8400007 | Atlanta | Georgia | 30318 | United States |
| Investigational Site Number 8400022 | Columbus | Georgia | 31904 | United States |
| Investigational Site Number 8400032 | Roswell | Georgia | 30076 | United States |
| Investigational Site Number 8400038 | Arlington Heights | Illinois | 60005 | United States |
| Investigational Site Number 8400005 | Des Moines | Iowa | 50314 | United States |
| Investigational Site Number 8400041 | Metairie | Louisiana | 70006 | United States |
| Investigational Site Number 8400015 | Rockville | Maryland | 20852-4267 | United States |
| Investigational Site Number 8400042 | Waltham | Massachusetts | 02453 | United States |
| Investigational Site Number 8400019 | Flint | Michigan | 48532-3447 | United States |
| Investigational Site Number 8400003 | Omaha | Nebraska | 68131 | United States |
| Investigational Site Number 8400024 | Henderson | Nevada | 89052 | United States |
| Investigational Site Number 8400028 | New York | New York | 10001 | United States |
| Investigational Site Number 8400025 | Morehead City | North Carolina | 28557 | United States |
| Investigational Site Number 8400010 | Wilmington | North Carolina | 28401 | United States |
| Investigational Site Number 8400023 | Fargo | North Dakota | 58104 | United States |
| Investigational Site Number 8400029 | Bend | Oregon | 97701 | United States |
| Investigational Site Number 8400033 | Chattanooga | Tennessee | 37404 | United States |
| Investigational Site Number 8400044 | Austin | Texas | 78731 | United States |
| Investigational Site Number 8400009 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 8400035 | Dallas | Texas | 75230 | United States |
| Investigational Site Number 8400021 | Dallas | Texas | 75246 | United States |
| Investigational Site Number 8400017 | Houston | Texas | 77043 | United States |
| Investigational Site Number 8400001 | Houston | Texas | 77079 | United States |
| Investigational Site Number 8400020 | Houston | Texas | 77089 | United States |
| Investigational Site Number 8400016 | Mesquite | Texas | 75149 | United States |
| Investigational Site Number 8400034 | Salt Lake City | Utah | 84102 | United States |
| Investigational Site Number 8400008 | Renton | Washington | 98057 | United States |
| Investigational Site Number 8400039 | Bridgeport | West Virginia | 26330 | United States |
| Investigational Site Number 2460006 | Jyväskylä | 40100 | Finland |
| Investigational Site Number 2460002 | Kuopio | 70100 | Finland |
| Investigational Site Number 2460004 | Pori | 28500 | Finland |
| Investigational Site Number 2460003 | Seinäjoki | 60100 | Finland |
| Investigational Site Number 2760001 | Berlin | 10115 | Germany |
| Investigational Site Number 2760006 | Essen | 45136 | Germany |
| Investigational Site Number 2760004 | Heidelberg | 69115 | Germany |
| Investigational Site Number 2760005 | Oldenburg in Holstein | 23758 | Germany |
| Investigational Site Number 2760002 | Pirna | 01796 | Germany |
| Investigational Site Number 3480012 | Balatonfüred | 8230 | Hungary |
| Investigational Site Number 3480011 | Budapest | 1036 | Hungary |
| Investigational Site Number 3480008 | Budapest | 1042 | Hungary |
| Investigational Site Number 3480001 | Budapest | 1062 | Hungary |
| Investigational Site Number 3480005 | Budapest | 1062 | Hungary |
| Investigational Site Number 3480004 | Budapest | 1139 | Hungary |
| Investigational Site Number 3480007 | Debrecen | 4031 | Hungary |
| Investigational Site Number 3480003 | Nagykanizsa | 8800 | Hungary |
| Investigational Site Number 3480010 | Nyíregyháza | 4400 | Hungary |
| Investigational Site Number 3480009 | Szentendre | 2000 | Hungary |
| Investigational Site Number 3920009 | Fukuyama-Shi | Japan |
| Investigational Site Number 3920008 | Higashiosaka-Shi | Japan |
| Investigational Site Number 3920007 | Kashiwara-Shi | Japan |
| Investigational Site Number 3920001 | Koriyama-Shi | Japan |
| Investigational Site Number 3920005 | Kumamoto | Japan |
| Investigational Site Number 3920003 | Mito | Japan |
| Investigational Site Number 3920010 | Osaka | Japan |
| Investigational Site Number 3920002 | Sagamihara-Shi | Japan |
| Investigational Site Number 3920004 | Shinjuku-Ku | Japan |
| Investigational Site Number 3920006 | Ushiku-Shi | Japan |
| Investigational Site Number 6160004 | Bialystok | 15-435 | Poland |
| Investigational Site Number 6160003 | Krakow | 31-501 | Poland |
| Investigational Site Number 6160005 | Krakow | 31-548 | Poland |
| Investigational Site Number 6160007 | Lublin | 20-538 | Poland |
| Investigational Site Number 6160006 | Nowy Sącz | 33-300 | Poland |
| Investigational Site Number 6160001 | Poznan | 60-834 | Poland |
| Investigational Site Number 6160002 | Warsaw | 02-507 | Poland |
| Investigational Site Number 6430001 | Saint Petersburg | 194358 | Russia |
| Investigational Site Number 6430002 | Samara | 443041 | Russia |
| Investigational Site Number 6430003 | Saratov | 410030 | Russia |
| Investigational Site Number 6430004 | Tomsk | 634050 | Russia |
| Background |
| Garg SK, Wernicke-Panten K, Wardecki M, Kramer D, Delalande F, Franek E, Sadeharju K, Monchamp T, Miossec P, Mukherjee B, Shah VN. Safety, Immunogenicity, and Glycemic Control of Insulin Aspart Biosimilar SAR341402 Versus Originator Insulin Aspart in People with Diabetes Also Using Insulin Glargine: 12-Month Results from the GEMELLI 1 Trial. Diabetes Technol Ther. 2020 Jul;22(7):516-526. doi: 10.1089/dia.2020.0008. Epub 2020 Mar 31. |
| 33432547 | Derived | Shah VN, Franek E, Wernicke-Panten K, Pierre S, Mukherjee B, Sadeharju K. Efficacy, Safety, and Immunogenicity of Insulin Aspart Biosimilar SAR341402 Compared with Originator Insulin Aspart in Adults with Diabetes (GEMELLI 1): A Subgroup Analysis by Prior Type of Mealtime Insulin. Diabetes Ther. 2021 Feb;12(2):557-568. doi: 10.1007/s13300-020-00992-x. Epub 2021 Jan 11. |
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine,up to Week 52.
| Treated |
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| COMPLETED | Completed 12-month on treatment period. |
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| NOT COMPLETED |
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Analysis was performed on all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | SAR341402 | SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| BG001 | NovoLog/NovoRapid | NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| 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) | Here, "Overall number of participants analyzed" = participants evaluable for this baseline measure. | Count of Participants | Participants |
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| Baseline Body Mass Index (BMI) | Mean | Standard Deviation | kilogram/meter square^2 (kg/m^2) |
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| Duration of Diabetes | Mean | Standard Deviation | years |
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| Glycated Haemoglobin | Mean | Standard Deviation | percentage of hemoglobin |
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| Randomization Strata of Types of Diabetes | Count of Participants | Participants |
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| Randomization Strata of Screening HbA1c Categories | Count of Participants | Participants |
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| Randomization Strata of Prior Use of NovoLog/NovoRapid | Here, "No" signifies participant who had prior use of Humalog/Liprolog; "Yes" signifies prior use of NovoLog/NovoRapid. | Count of Participants | Participants |
| |||||||||||||||
| Randomization strata of geographical region | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 | All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted least square (LS) means and standard errors (SE) were obtained using an analysis of covariance (ANCOVA) model on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, irrespective of compliance with the study protocol and procedures. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 26 |
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| Secondary | Change in HbA1c From Baseline to Week 52 | All values up to Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c was calculated by subtracting baseline value from Week 52 value. Missing changes at Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Analysis was performed on ITT population. | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 52 |
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| Secondary | Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders. | Analysis was performed on ITT population. | Posted | Number | percentage of participants | Week 26 and Week 52 |
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| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 | All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG at Week 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Analysis was performed on ITT population. | Posted | Least Squares Mean | Standard Error | millimoles per liter (mmol/L) | Baseline, Week 26, and Week 52 |
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| Secondary | Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52 | Mean 24-hour plasma glucose concentration was calculated based on 7-point self-measured plasma glucose (SMPG) profiles with plasma glucose measurements before and 2-hours after each main meal and at bedtime. Mean 24-hour plasma glucose concentration was calculated for each profile and then averaged across profiles performed in the week before a visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Analysis was performed on ITT population. Here, "Overall number of participants analyzed" = participants with a baseline mean 24-hour plasma glucose concentration. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26, and Week 52 |
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| Secondary | Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52 | Plasma glucose excursions were calculated at breakfast, lunch and dinner for each 7-point SMPG profile, as 2-hour PPG minus plasma glucose value obtained 30 minutes prior to start of the meal. Values of plasma glucose excursions at each visit were then calculated as the average across profiles performed in the week before the visit. All calculated values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions at Weeks 26 and 52 was calculated by subtracting baseline value from Week 26 and Week 52 values, respectively. Missing changes at Week 26 and Week 52 were imputed using a return-to-baseline multiple imputation method (values imputed as participant baseline plus an error). Adjusted LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Analysis was performed on ITT population. Here, "Number analyzed" = participants with a baseline value for each specified category. | Posted | Least Squares Mean | Standard Error | mmol/L | Baseline, Week 26, and Week 52 |
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| Secondary | Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point | 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26, and Week 52): before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, and bedtime. For each time point, the value at each visit was calculated as the average of values obtained for the same time point across profiles performed in the week before the visit. | Analysis was performed on ITT population. Here, "Number analyzed" = participants with an available value at baseline, Week 26/Week 52 for the specified 7-point SMPG time point. | Posted | Mean | Standard Deviation | mmol/L | Baseline, Week 26, and Week 52 |
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| Secondary | Number of Participants With at Least One Hypoglycemic 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, 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 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). | Analysis was performed on safety population that included all randomized participants who received at least one dose of IMP, analyzed according to the treatment actually received. | Posted | Count of Participants | Participants | From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Secondary | Number of Hypoglycemia Events Per Participant-Year | Number of hypoglycemia events (any, severe and documented [both thresholds]) 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 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). | Analysis was performed on safety population. | Posted | Number | events per participant-year | From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Secondary | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | Participants with at least one treatment-emergent adverse event linked to hypersensitivity reaction and injection site reaction regardless of relationship to IMP during the main 6-month and the 12-month on-treatment periods was assessed and reported. | Analysis was performed on safety population. | Posted | Number | percentage of participants | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Secondary | Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample | Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence). | Analysis was performed on AIA population, which included all participants who received at least one dose of IMP and had at least one AIA sample available for analysis during the on-treatment period, analyzed according to the treatment actually received. Here, "Number analyzed" = participants included in the AIA population at Week 26 and Week 52. | Posted | Number | percentage of participants | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Secondary | Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs) | AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following 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). 2) Participants with treatment-boosted AIAs were those 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). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. | Analysis was performed on AIA population. Here, 'Number analyzed' = participants included in the AIA population at Week 26 and Week 52 and with negative or missing AIA status at baseline (for treatment-induced AIA) or with positive AIA status at baseline (for treatment-boosted AIA). | Posted | Number | percentage of participants | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Other Pre-specified | Change in Glycated Hemoglobin A1c From Baseline to Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | All values up to Week 26 and Week 52 were taken into account in the analysis, regardless of adherence to treatment. Change in HbA1c at Week 26 and Week 52 was calculated by subtracting baseline value from Week 26 and Week 52 value, respectively. Missing changes at Week 26 and Week 52 were imputed using a retrieved dropout multiple imputation method (separately for participants who prematurely discontinued or completed treatment). Adjusted LS means and SE were obtained using ANCOVA model on data obtained from the multiple imputations (results were combined using Rubin's formulae). | Analysis was performed on ITT population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). | Posted | Least Squares Mean | Standard Error | percentage of HbA1c | Baseline, Week 26 and Week 52 |
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| Other Pre-specified | Number of Participants With at Least One Hypoglycemic Event: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | 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 mg/dL) or plasma glucose level of <3.0 mmol/L (<54 mg/dL). | Analysis was performed on safety population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). | Posted | Count of Participants | Participants | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Other Pre-specified | Number of Participants With Adverse Events: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | Any untoward medical occurrence in a participant who received IMP was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during the main 6-month or 12-month on-treatment periods. | Analysis was performed on safety population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). | Posted | Count of Participants | Participants | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Other Pre-specified | Percentage of Participants With Treatment-Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs): Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | AIA incidence were categorized as: treatment-induced, treatment-boosted AIAs, and treatment-emergent AIA. 1) Participants with treatment-induced AIAs were those who developed AIA following 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. 2) Participants with treatment-boosted AIAs were those 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). 3) Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. Data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). | Analysis was performed on AIA population. Here, 'Number analyzed' = participants included in the AIA population at Week 26 and Week 52 and with negative or missing AIA status at baseline (for treatment-induced AIA) or with positive AIA status at baseline (for treatment-boosted AIA). | Posted | Number | percentage of participants | From first injection of IMP up to Week 26 or up to 1 day after last injection of IMP, whichever comes earlier, for Week 26 analysis, and from first injection of IMP up to 1 day after last injection of IMP for Week 52 |
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| Other Pre-specified | Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52 | Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit. | Analysis was performed on safety population. Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | Units/kilogram (U/kg) | Baseline, Day 1, Week 26 and Week 52 |
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| Post-Hoc | Change in Daily Insulin Dose From Baseline to Day 1, Week 26 and Week 52: Subgroup Analysis by Prior Use of NovoLog/NovoRapid or Humalog/Liprolog | Change in daily insulin dose (basal, mealtime and total) was calculated by subtracting baseline value from Day 1, Week 26 and Week 52 values respectively. Baseline was defined as the median of daily doses available in the week prior to the first injection of IMP (corresponding to doses of the pre-study insulin), value at Day 1 as the median of daily doses available in the week after the first injection of IMP (first doses of IMP), and value at Week 26 and Week 52 as the median of daily doses available in the week prior to each visit. | Analysis was performed on safety population and data was summarized separately for each treatment arm in each subgroup (based on the prior use of NovoLog/NovoRapid or Humalog/Liprolog). Here, 'Number analyzed' = participants with available data for each specified category. | Posted | Mean | Standard Deviation | U/kg | Baseline, Day 1, Week 26, Week 52 |
|
All Adverse Events (AEs) weeks were collected from signature of the informed consent form up to the study completion (up to 52 Weeks) regardless of seriousness or relationship to investigational product.
Reported AEs and deaths are treatment-emergent AEs, that is AEs that developed/worsened or became serious and deaths that occurred during the '12-month on-treatment period' (time from the first injection of IMP up to 1 day after the last injection of IMP). Analysis was performed on safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SAR341402 | SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. | 1 | 301 | 36 | 301 | 70 | 301 |
| EG001 | NovoLog/NovoRapid | NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. | 2 | 296 | 29 | 296 | 66 | 296 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myocardial Infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac Arrest | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Cardiac Failure Congestive | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Chronic Left Ventricular Failure | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 21.1 | Systematic Assessment |
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| Inappropriate Antidiuretic Hormone Secretion | Endocrine disorders | MedDRA 21.1 | Systematic Assessment |
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| Colitis Ischaemic | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Gastric Ulcer | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Peptic Ulcer Haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Small Intestinal Haemorrhage | Gastrointestinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Sudden Death | General disorders | MedDRA 21.1 | Systematic Assessment |
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| Biliary Dyskinesia | Hepatobiliary disorders | MedDRA 21.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Bronchitis Bacterial | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Clostridium Difficile Colitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Diabetic Foot Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Endophthalmitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Osteomyelitis Chronic | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Pyelonephritis Acute | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Wound Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Accidental Overdose | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Device Use Error | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Procedural Pain | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Ulna Fracture | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Vascular Pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 21.1 | Systematic Assessment |
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| Diabetic Ketoacidosis | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 21.1 | Systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Colon Adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Pancreatic Carcinoma Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Prolymphocytic Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Squamous Cell Carcinoma Of Skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 21.1 | Systematic Assessment |
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| Carpal Tunnel Syndrome | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Epilepsy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Hyperglycaemic Unconsciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycaemic Coma | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycaemic Seizure | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Hypoglycaemic Unconsciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Loss Of Consciousness | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Polyneuropathy | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Transient Ischaemic Attack | Nervous system disorders | MedDRA 21.1 | Systematic Assessment |
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| Intercapillary Glomerulosclerosis | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
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| Tubulointerstitial Nephritis | Renal and urinary disorders | MedDRA 21.1 | Systematic Assessment |
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| Acute Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Atelectasis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumonia Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pneumothorax Spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 21.1 | Systematic Assessment |
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| Diabetic Foot | Skin and subcutaneous tissue disorders | MedDRA 21.1 | Systematic Assessment |
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| Deep Vein Thrombosis | Vascular disorders | MedDRA 21.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 21.1 | Systematic Assessment |
|
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 | Trial Transparency Team | 800-633-1610 | 1# | Contact-US@sanofi.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 28, 2018 | Jul 16, 2019 | SAP_001.pdf |
| 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
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NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52.
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Participants |
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| OG001 |
| NovoLog/NovoRapid |
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
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| OG002 | Prior Humalog/Liprolog Use: SAR341402 | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG003 | Prior Humalog/Liprolog Use: NovoLog/NovoRapid | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
|
|
| OG002 | Prior Humalog/Liprolog Use: SAR341402 | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG003 | Prior Humalog/Liprolog Use: NovoLog/NovoRapid | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
|
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| OG002 | Prior Humalog/Liprolog Use: SAR341402 | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG003 | Prior Humalog/Liprolog Use: NovoLog/NovoRapid | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
|
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Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG001 | Prior NovoLog/NovoRapid Use: NovoLog/NovoRapid | Participants with prior use of NovoLog/NovoRapid (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG002 | Prior Humalog/Liprolog Use: SAR341402 | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG003 | Prior Humalog/Liprolog Use: NovoLog/NovoRapid | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
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| Participants |
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| OG002 | Prior Humalog/Liprolog Use: SAR341402 | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
| OG003 | Prior Humalog/Liprolog Use: NovoLog/NovoRapid | Participants with prior use of Humalog/Liprolog (as per randomization stratum), receiving NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 52. |
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