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Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine (GEMELLI 1)

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ClinicalTrials.gov Identifier: NCT03211858
Recruitment Status : Completed
First Posted : July 7, 2017
Results First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus
Interventions Drug: Insulin Lispro
Drug: Novolog/Novorapid
Drug: Insulin glargine (HOE901)
Enrollment 597
Recruitment Details 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 <7.0% or >10% at the screening visit.
Pre-assignment Details Randomization was stratified by HbA1c at screening visit (<8%, >=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). Data reported based on primary completion date, 16 July 2018.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description SAR341402 100 units per milliliter (U/mL) subcutaneous (SC) injection, before meals intake on top of once daily (QD) Insulin Glargine, up to Week 26. NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Period Title: Overall Study
Started 301 296
Treated 301 296
Completed [1] 279 274
Not Completed 22 22
Reason Not Completed
Adverse Event             5             3
Lack of Efficacy             0             3
Poor compliance to protocol             3             0
Non-serious Hypoglycemia             1             0
Other than specified above             13             16
[1]
Completed the main 6-month treatment period.
Arm/Group Title SAR341402 NovoLog/NovoRapid Total
Hide Arm/Group Description SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26. NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26. Total of all reporting groups
Overall Number of Baseline Participants 301 296 597
Hide Baseline Analysis Population Description
Analysis was performed on all randomized participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 296 participants 597 participants
48.4  (14.8) 47.8  (15.4) 48.1  (15.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 301 participants 296 participants 597 participants
Female
122
  40.5%
119
  40.2%
241
  40.4%
Male
179
  59.5%
177
  59.8%
356
  59.6%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 300 participants 293 participants 593 participants
American Indian or Alaska Native
0
   0.0%
2
   0.7%
2
   0.3%
Asian
37
  12.3%
37
  12.6%
74
  12.5%
Native Hawaiian or Other Pacific Islander
3
   1.0%
0
   0.0%
3
   0.5%
Black or African American
11
   3.7%
8
   2.7%
19
   3.2%
White
248
  82.7%
242
  82.6%
490
  82.6%
More than one race
0
   0.0%
3
   1.0%
3
   0.5%
Unknown or Not Reported
1
   0.3%
1
   0.3%
2
   0.3%
[1]
Measure Analysis Population Description: Here, “Overall number of participants analyzed” = participants evaluable for this baseline measure.
Baseline Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kilogram/meter square^2 (kg/m^2)
Number Analyzed 301 participants 296 participants 597 participants
27.45  (4.58) 27.46  (4.99) 27.45  (4.78)
Duration of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 301 participants 296 participants 597 participants
19.5  (11.9) 19.4  (11.8) 19.5  (11.8)
Glycated Haemoglobin (HbA1c %)  
Mean (Standard Deviation)
Unit of measure:  Percentage of hemoglobin
Number Analyzed 301 participants 296 participants 597 participants
8.00  (0.77) 7.94  (0.70) 7.97  (0.74)
1.Primary Outcome
Title Change in Glycated Hemoglobin A1c From Baseline to Week 26
Hide Description 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).
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, irrespective of compliance with the study protocol and procedures.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Least Squares Mean (Standard Error)
Unit of Measure: percentage of HbA1c
-0.38  (0.042) -0.30  (0.041)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SAR341402, NovoLog/NovoRapid
Comments Analysis was performed using ANCOVA with treatment group (SAR341402, NovoLog/NovoRapid), the randomization strata of geographical region, type of diabetes and prior use of NovoLog/NovoRapid as fixed categorical effects, as well as the continuous fixed covariate of baseline HbA1c value.
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of SAR341402 over NovoLog/NovoRapid was demonstrated if upper bound of the 2-sided 95% confidence interval (CI) of the difference between SAR341402 and NovoLog/NovoRapid was <0.3%. If non-inferiority was demonstrated, using a hierarchical step down testing procedure, the inverse non-inferiority of NovoLog/NovoRapid over SAR341402 was tested and was demonstrated if lower bound of the 2-sided 95% CI of the difference between SAR341402 and NovoLog/NovoRapid was > -0.3%.
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -0.08
Confidence Interval (2-Sided) 95%
-0.192 to 0.039
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.059
Estimation Comments SAR341402 vs Novolog/Novorapid
2.Secondary Outcome
Title Percentage of Participants With HbA1c <7 % at Week 26
Hide Description Participants who had no available assessment at Week 26 were considered as non-responders.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Measure Type: Number
Unit of Measure: percentage of participants
16.6 14.5
3.Secondary Outcome
Title Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26
Hide Description All values up to Week 26 were taken into account in the analysis, regardless of adherence to treatment. Change in FPG 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 LS means and SE were obtained using ANCOVA analysis on data obtained from the multiple imputations (results were combined using Rubin's formulae).
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Least Squares Mean (Standard Error)
Unit of Measure: millimoles per liter (mmol/L)
-0.49  (0.249) -0.17  (0.245)
4.Secondary Outcome
Title Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26
Hide Description 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 were taken into account in the analysis, regardless of adherence to treatment. Change in mean 24-hour plasma glucose concentration was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 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).
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, “Overall number of participants analyzed” = participants with a baseline mean 24-hour plasma glucose concentration.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 295
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
-0.34  (0.120) -0.53  (0.121)
5.Secondary Outcome
Title Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26
Hide Description 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 were taken into account in the analysis, regardless of adherence to treatment. Change in PPG excursions was calculated by subtracting baseline value from Week 26 value. Missing changes at Week 26 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).
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, “Number analyzed” = participants with a baseline value for each specified category.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Least Squares Mean (Standard Error)
Unit of Measure: mmol/L
At Breakfast Number Analyzed 288 participants 288 participants
0.50  (0.232) 0.65  (0.233)
At Lunch Number Analyzed 290 participants 291 participants
0.18  (0.230) 0.12  (0.228)
At Dinner Number Analyzed 290 participants 292 participants
0.36  (0.243) 0.66  (0.243)
6.Secondary Outcome
Title Change in 7-Point SMPG Profiles From Baseline to Week 26 Per Time Point
Hide Description 7-point SMPG profiles were measured at the following 7 points at each visit (Baseline, Week 26): 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.
Time Frame Baseline, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on ITT population. Here, “Number analyzed” = participants with an available value at baseline and Week 26 for the specified 7-point SMPG time point.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Mean (Standard Deviation)
Unit of Measure: mmol/L
Before Breakfast Number Analyzed 254 participants 253 participants
-0.62  (4.48) -0.48  (4.00)
2 Hours After Breakfast Number Analyzed 236 participants 229 participants
-0.39  (4.97) -0.30  (4.12)
Before Lunch Number Analyzed 250 participants 253 participants
-0.60  (4.14) -0.60  (4.25)
2 Hours After Lunch Number Analyzed 246 participants 251 participants
-0.61  (4.54) -0.62  (4.65)
Before Dinner Number Analyzed 256 participants 251 participants
-0.04  (4.87) -0.78  (4.12)
2 Hours After Dinner Number Analyzed 240 participants 245 participants
-0.36  (4.71) -0.25  (4.14)
Bedtime Number Analyzed 239 participants 238 participants
-0.71  (5.13) -0.54  (4.03)
7.Secondary Outcome
Title Number of Participants With at Least One Hypoglycemic Event
Hide Description Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, 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). Percentage of participants with at least one hypoglycemia event (any, severe and documented [both thresholds]) were reported.
Time Frame From first injection of investigational medicinal product (IMP) up to Week 26 or up to 1 day after the last injection of IMP, whichever comes earlier
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Measure Type: Count of Participants
Unit of Measure: Participants
Any hypoglycemia
291
  96.7%
285
  96.3%
Severe hypoglycemia
12
   4.0%
10
   3.4%
Documented symptomatic hypoglycemia (<=3.9 mmol/L)
264
  87.7%
251
  84.8%
Documented symptomatic hypoglycemia (< 3.0 mmol/L)
206
  68.4%
193
  65.2%
8.Secondary Outcome
Title Number of Hypoglycemia Events Per Participant-Year
Hide Description 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).
Time Frame From first injection of IMP up to Week 26 or up to 1 day after the last injection of IMP, whichever come earlier
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Measure Type: Number
Unit of Measure: events per participant-year
Any hypoglycemia 72.96 69.31
Severe hypoglycemia 0.14 0.10
Documented symptomatic hypoglycemia (<=3.9 mmol/L) 40.24 36.27
Documented symptomatic hypoglycemia (< 3.0 mmol/L) 11.10 9.78
9.Secondary Outcome
Title Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions
Hide Description 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 on-treatment period was assessed and reported.
Time Frame From first injection of IMP up to Week 26 or up to 1 day after the last injection of IMP, whichever come earlier
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on safety population.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 301 296
Measure Type: Number
Unit of Measure: percentage of participants
Hypersensitivity Reactions 3.7 3.7
Injection site reactions 0.7 1.4
10.Secondary Outcome
Title Percentage of Participants With at Least One Positive Anti-Insulin Aspart Antibodies (AIA) Sample
Hide Description Participants with at least one positive AIA sample at baseline or at any time during the on-treatment period (Prevalence).
Time Frame From baseline up to Week 26 or up to 1 day after the last injection of IMP, whichever come earlier
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 296 292
Measure Type: Number
Unit of Measure: percentage of participants
48.0 52.4
11.Secondary Outcome
Title Percentage of Participants With Treatment Induced, Treatment-Boosted and Treatment-Emergent Anti-insulin Aspart Antibodies (AIAs)
Hide Description 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.
Time Frame From first injection of IMP up to Week 26 or up to 1 day after the last injection of IMP, whichever come earlier
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis was performed on AIA population. Here, 'Number analyzed' = participants with baseline value for each specified category.
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description:
SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
Overall Number of Participants Analyzed 296 292
Measure Type: Number
Unit of Measure: percentage of participants
Treatment-Induced AIA Number Analyzed 200 participants 194 participants
23.0 28.4
Treatment-Boosted AIA Number Analyzed 96 participants 98 participants
4.2 5.1
Treatment-Emergent AIA Number Analyzed 296 participants 292 participants
16.9 20.5
Time Frame All Adverse Events (AEs) weeks were collected from signature of the informed consent form up to the primary completion date (up to 26 Weeks) regardless of seriousness or relationship to investigational product.
Adverse Event Reporting Description Reported AEs and deaths are treatment-emergent AEs, that is AEs that developed/worsened or became serious and deaths that occurred during the ‘main 6-month on-treatment period’ (time from the first injection of IMP to Week 26 or up to 1 day after the last injection of IMP, whichever comes earlier). Analysis was performed on safety population.
 
Arm/Group Title SAR341402 NovoLog/NovoRapid
Hide Arm/Group Description SAR341402 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26. NovoLog/NovoRapid 100 U/mL SC injection, before meals intake on top of QD Insulin Glargine, up to Week 26.
All-Cause Mortality
SAR341402 NovoLog/NovoRapid
Affected / at Risk (%) Affected / at Risk (%)
Total   0/301 (0.00%)      1/296 (0.34%)    
Show Serious Adverse Events Hide Serious Adverse Events
SAR341402 NovoLog/NovoRapid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   25/301 (8.31%)      18/296 (6.08%)    
Cardiac disorders     
Acute Myocardial Infarction  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Angina Pectoris  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Myocardial Infarction  1  0/301 (0.00%)  0 1/296 (0.34%)  2
Gastrointestinal disorders     
Gastric Ulcer  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Peptic Ulcer Haemorrhage  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Small Intestinal Haemorrhage  1  1/301 (0.33%)  1 0/296 (0.00%)  0
General disorders     
Chest Pain  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Sudden Death  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Infections and infestations     
Bronchitis Bacterial  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Cellulitis  1  0/301 (0.00%)  0 2/296 (0.68%)  2
Clostridium Difficile Colitis  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Diabetic Foot Infection  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Herpes Zoster  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Osteomyelitis Chronic  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Pneumonia  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Pyelonephritis Acute  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Wound Infection  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Injury, poisoning and procedural complications     
Accidental Overdose  1  3/301 (1.00%)  8 2/296 (0.68%)  2
Device Use Error  1  2/301 (0.66%)  2 0/296 (0.00%)  0
Procedural Pain  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Road Traffic Accident  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Ulna Fracture  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Metabolism and nutrition disorders     
Diabetic Ketoacidosis  1  2/301 (0.66%)  2 0/296 (0.00%)  0
Hypoglycaemia  1  3/301 (1.00%)  9 1/296 (0.34%)  1
Musculoskeletal and connective tissue disorders     
Intervertebral Disc Protrusion  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Rotator Cuff Syndrome  1  2/301 (0.66%)  2 0/296 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Colon Adenoma  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Hepatic Cancer  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Pancreatic Carcinoma  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Prolymphocytic Leukaemia  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Nervous system disorders     
Carpal Tunnel Syndrome  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Hypoglycaemic Coma  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Hypoglycaemic Seizure  1  0/301 (0.00%)  0 2/296 (0.68%)  2
Hypoglycaemic Unconsciousness  1  6/301 (1.99%)  9 3/296 (1.01%)  4
Loss Of Consciousness  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Polyneuropathy  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Syncope  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Transient Ischaemic Attack  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Renal and urinary disorders     
Intercapillary Glomerulosclerosis  1  0/301 (0.00%)  0 1/296 (0.34%)  1
Respiratory, thoracic and mediastinal disorders     
Atelectasis  1  1/301 (0.33%)  1 0/296 (0.00%)  0
Skin and subcutaneous tissue disorders     
Diabetic Foot  1  2/301 (0.66%)  4 0/296 (0.00%)  0
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SAR341402 NovoLog/NovoRapid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   41/301 (13.62%)      49/296 (16.55%)    
Infections and infestations     
Nasopharyngitis  1  25/301 (8.31%)  31 25/296 (8.45%)  28
Upper Respiratory Tract Infection  1  16/301 (5.32%)  22 26/296 (8.78%)  29
1
Term from vocabulary, MedDra 21.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Trial Transparency Team
Organization: Sanofi
Phone: 800-633-1610 ext 1#
EMail: Contact-US@sanofi.com
Layout table for additonal information
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT03211858     History of Changes
Other Study ID Numbers: EFC15081
2017-000091-28 ( EudraCT Number )
U1111-1191-5775 ( Other Identifier: UTN )
First Submitted: July 6, 2017
First Posted: July 7, 2017
Results First Submitted: July 15, 2019
Results First Posted: August 8, 2019
Last Update Posted: August 8, 2019