Trial · NCT03211858
Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
NCT03211858, Phase 3, Completed, Sanofi; results first posted 2019-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine. Trials, record NCT03211858. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03211858
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of SAR341402 to NovoLog/NovoRapid in Adult Patients With Diabetes Mellitus Also Using Insulin Glargine
- NCT number
- NCT03211858
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 597 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Type 1 Diabetes Mellitus-Type 2 Diabetes Mellitus
- Interventions
- Insulin aspart, NovoLog/NovoRapid, Insulin glargine (HOE901)
- First posted
- 2017-07-07
- Last updated
- 2022-03-28
- Other registries' IDs
- eudract:2017-000091-28
- Results first posted
- 2019-08-08
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 | Baseline, 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). |
| Secondary | Change in HbA1c From Baseline to Week 52 | Baseline, 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). |
| Secondary | Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | Week 26 and Week 52 | Participants who had no available assessment at Week 26 and Week 52 were considered as non-responders. |
| Secondary | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 | Baseline, 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). |
| Secondary | Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52 | Baseline, 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). |
| Secondary | Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52 | Baseline, 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). |
| Secondary | Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point | Baseline, Week 26, and Week 52 | 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. |
| Secondary | Number of Participants With at Least One Hypoglycemic Event | 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 | 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). |
| Secondary | Number of Hypoglycemia 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 | 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). |
| Secondary | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | 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 | 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. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 | Baseline, Week 26 | Analysis was performed on intent-to-treat (ITT) population, which included all randomized participants, irrespective of compliance with the study protocol and procedures. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Change in HbA1c From Baseline to Week 52 | Baseline, Week 52 | Analysis was performed on ITT population. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | Week 26 and Week 52 | Analysis was performed on ITT population. | percentage of participants | NUMBER |
| SECONDARY | Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 | Baseline, Week 26, and Week 52 | Analysis was performed on ITT population. | millimoles per liter (mmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change in the Mean 24-hour Plasma Glucose Concentration From Baseline to Week 26 and Week 52 | Baseline, Week 26, and Week 52 | Analysis was performed on ITT population. Here, Overall number of participants analyzed = participants with a baseline mean 24-hour plasma glucose concentration. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Postprandial Plasma Glucose (PPG) Excursion From Baseline to Week 26 and Week 52 | Baseline, Week 26, and Week 52 | Analysis was performed on ITT population. Here, Number analyzed = participants with a baseline value for each specified category. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change in 7-Point SMPG Profiles From Baseline to Week 26 and Week 52 Per Time Point | Baseline, Week 26, and Week 52 | 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. | mmol/L | MEAN |
| SECONDARY | Number of Participants With at Least One Hypoglycemic Event | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Hypoglycemia 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 | Analysis was performed on safety population. | events per participant-year | NUMBER |
| SECONDARY | Percentage of Participants With Hypersensitivity Reactions and Injection Site Reactions | 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 | Analysis was performed on safety population. | percentage of participants | NUMBER |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group238
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 | SAR341402 | -0.38 | Standard Error 0.042 | percentage of HbA1c | |
| Change in Glycated Hemoglobin A1c (HbA1c) From Baseline to Week 26 | NovoLog/NovoRapid | -0.30 | Standard Error 0.041 | percentage of HbA1c | |
| Change in HbA1c From Baseline to Week 52 | SAR341402 | -0.25 | Standard Error 0.057 | percentage of HbA1c | |
| Change in HbA1c From Baseline to Week 52 | NovoLog/NovoRapid | -0.26 | Standard Error 0.059 | percentage of HbA1c | |
| Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | SAR341402 | At Week 26 | 16.6 | percentage of participants | |
| Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | NovoLog/NovoRapid | At Week 26 | 14.5 | percentage of participants | |
| Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | SAR341402 | At Week 52 | 19.6 | percentage of participants | |
| Percentage of Participants With HbA1c <7% at Week 26 and Week 52 | NovoLog/NovoRapid | At Week 52 | 18.2 | percentage of participants | |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 | SAR341402 | At Week 26 | -0.49 | Standard Error 0.249 | millimoles per liter (mmol/L) |
| Change in Fasting Plasma Glucose (FPG) From Baseline to Week 26 and Week 52 | NovoLog/NovoRapid | At Week 26 | -0.17 | Standard Error 0.245 | millimoles per liter (mmol/L) |
1 to 10 of 238Source ClinicalTrials.gov
See all 238 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SAR341402 | 301 | |
| Overall Study | STARTED | NovoLog/NovoRapid | 296 | |
| Overall Study | Treated | SAR341402 | 301 | |
| Overall Study | Treated | NovoLog/NovoRapid | 296 | |
| Overall Study | COMPLETED | SAR341402 | 264 | |
| Overall Study | COMPLETED | NovoLog/NovoRapid | 263 | |
| Overall Study | NOT COMPLETED | SAR341402 | 37 | |
| Overall Study | NOT COMPLETED | NovoLog/NovoRapid | 33 |
Source ClinicalTrials.gov
Adverse events132
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Influenza | Infections and infestations | SAR341402 | 15 | 301 | 15 |
| other | Influenza | Infections and infestations | NovoLog/NovoRapid | 12 | 296 | 13 |
| other | Nasopharyngitis | Infections and infestations | SAR341402 | 34 | 301 | 45 |
| other | Nasopharyngitis | Infections and infestations | NovoLog/NovoRapid | 29 | 296 | 39 |
| other | Upper Respiratory Tract Infection | Infections and infestations | SAR341402 | 22 | 301 | 28 |
| other | Upper Respiratory Tract Infection | Infections and infestations | NovoLog/NovoRapid | 28 | 296 | 31 |
| serious | Acute Myocardial Infarction | Cardiac disorders | SAR341402 | 1 | 301 | 1 |
| serious | Acute Myocardial Infarction | Cardiac disorders | NovoLog/NovoRapid | 0 | 296 | 0 |
| serious | Angina Pectoris | Cardiac disorders | SAR341402 | 0 | 301 | 0 |
| serious | Angina Pectoris | Cardiac disorders | NovoLog/NovoRapid | 1 | 296 | 1 |
1 to 10 of 132Source ClinicalTrials.gov
See all 132 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SAR341402 | 1 | 301 |
| Total, all-cause mortality | NovoLog/NovoRapid | 2 | 296 |
| Total, other adverse events | SAR341402 | 70 | 301 |
| Total, other adverse events | NovoLog/NovoRapid | 66 | 296 |
| Total, serious adverse events | SAR341402 | 36 | 301 |
| Total, serious adverse events | NovoLog/NovoRapid | 29 | 296 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| SAR341402 vs NovoLog/NovoRapid: deaths from any cause | Trial comparisons |
| SAR341402 vs NovoLog/NovoRapid: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03211858
GET https://conductscience.org/api/trials/v1/NCT03211858/results?page=2