A Phase 3 interventional study of Insulin Aspart SAR341402 and Insulin Aspart in Type 1 Diabetes Mellitus, sponsored by Sanofi. Completed at 33 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Sanofi · Phase 3, Interventional, and Treatment
Primary Objective:
To demonstrate similarity in pharmacokinetics (PK) of SAR341402 and NovoLog after 4x4-week periods of alternating administration of SAR341402 and NovoLog compared to 16-week continuous use of NovoLog in participants with Type 1 diabetes mellitus (T1DM) also using insulin glargine.
Secondary Objectives:
The study duration per participant was less than 19 weeks (for participants who did not require the run-in period) and less than 31 weeks (for participants who require the run-in period).
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Participants exclusively on a multiple (greater than or equal to 3) daily injection insulin analogue regimen using:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Participants self-administered subcutaneous (SC) injection daily prior to the start of a meal during the 16-week treatment period, starting with NovoLog (100 units per milliliters \[U/mL\]) for the first 4 weeks, then SAR341402 (100 U/mL) for 4 weeks, followed by NovoLog (at same dose) for 4 weeks and then SAR341402 (at same dose) for the last 4 weeks on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin.
Drug: Insulin Aspart SAR341402 · Drug: Insulin Aspart · Drug: Insulin glargine U100
Participants self-administered SC injection of NovoLog (100 U/mL) daily prior to the start of a meal during the 16-week treatment period on top of mandatory background therapy with Lantus (Insulin glargine, 100 U/mL) as basal insulin.
Drug: Insulin Aspart · Drug: Insulin glargine U100
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Also known as: NovoLog
Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
Also known as: Lantus
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog.
Time frame: 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112
Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
Time frame: 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2 hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112
Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
Time frame: 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112
Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs)
AIA was categorized as: treatment-induced AIA, treatment-boosted AIA, and treatment-emergent AIA. Treatment-induced AIAs: participants who developed AIA following investigational medicinal product (IMP) administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing Baseline sample). Treatment-boosted AIAs: participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to Baseline value at any time during on-treatment period, in those participants with pre-existing AIA). Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. On-treatment period was defined as the time from the first injection of IMP up to the last injection of IMP + 1 day.
Time frame: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)
Number of Participants With at Least One Hypoglycemic Event
Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant was not capable of helping self. Documented symptomatic hypoglycemia: event in which typical symptoms of hypoglycemia (SOH) were accompanied by measured plasma glucose concentration (PGC) less than or equal to (\<=) 3.9 millimoles per liter (mmol/L)(\<70 milligrams per deciliter \[mg/dL\]) or \<3.0 mmol/L(\<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and with measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L (\<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC \<=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC greater than (\>) 3.9 mmol/L (70 mg/dL).
Time frame: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)
Number of Hypoglycemic Events Per Participant-year
Number of hypoglycemia events (any, severe, documented \[both threshold\], asymptomatic \[both threshold\], probable symptomatic and relative) per participant-year of exposure were reported. Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant wasn't capable of helping self. Documented symptomatic hypoglycemia: event in which typical SOH were accompanied by measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L(\<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L(\<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC \<=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC \>3.9 mmol/L (70 mg/dL).
Time frame: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the on-treatment period (from first injection of IMP up to 1 day after the last injection of IMP).
Time frame: From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)
Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm)
Tmax was defined as the time taken to reach the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
Time frame: 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112
Study was conducted at 31 active sites in the United States. A total of 279 participants were screened from 11 March 2019 to 30 Oct 2019, out of which 210 participants were randomized. Participants were randomized in 1:1 ratio to "switching arm" (NovoLog/SAR341402) and "non-switching arm" (NovoLog). Randomization was stratified by glycated hemoglobin A1c (HbA1c) (less than \[\<\] 8.0 percent \[%\] and greater than or equal to \[\>=\] 8.0%) obtained at screening visit.
| Milestone | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Started | 104 | 106 |
| Treated | 104 | 106 |
| Safety population | 99 | 111 |
| Anti-insulin antibody (aia) population | 98 | 107 |
| Completed | 95 | 105 |
| Not completed | 9 | 1 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Poor compliance to protocol | 5 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Other-unspecified | 1 | 0 |
AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog.
| picograms*hour per milliliter (pg*h/mL) | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | 8960 ± 18300 | 7190 ± 6530 |
AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
| pg*h/mL | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | 6720 ± 3700 | 7260 ± 6370 |
Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
| picograms per milliliter (pg/mL) | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | 11800 ± 65600 | 3330 ± 8850 |
AIA was categorized as: treatment-induced AIA, treatment-boosted AIA, and treatment-emergent AIA. Treatment-induced AIAs: participants who developed AIA following investigational medicinal product (IMP) administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing Baseline sample). Treatment-boosted AIAs: participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to Baseline value at any time during on-treatment period, in those participants with pre-existing AIA). Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. On-treatment period was defined as the time from the first injection of IMP up to the last injection of IMP + 1 day.
| Participants | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Treatment-emergent AIA | 8 | 11 |
| Treatment-boosted AIA | 0 | 1 |
| Treatment-induced AIA | 8 | 10 |
Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant was not capable of helping self. Documented symptomatic hypoglycemia: event in which typical symptoms of hypoglycemia (SOH) were accompanied by measured plasma glucose concentration (PGC) less than or equal to (\<=) 3.9 millimoles per liter (mmol/L)(\<70 milligrams per deciliter \[mg/dL\]) or \<3.0 mmol/L(\<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and with measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L (\<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC \<=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC greater than (\>) 3.9 mmol/L (70 mg/dL).
| Participants | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Any hypoglycemia | 95 | 105 |
| Severe hypoglycemia | 6 | 4 |
| Documented symptomatic hypoglycemia <=3.9 mmol/L | 89 | 98 |
| Documented symptomatic hypoglycemia < 3.0 mmol/L | 78 | 90 |
| Asymptomatic hypoglycemia <= 3.9 mmol/L | 69 | 68 |
| Asymptomatic hypoglycemia < 3.0 mmol/L | 48 | 44 |
| Probable symptomatic hypoglycemia | 8 | 9 |
| Relative hypoglycemia | 3 | 2 |
Number of hypoglycemia events (any, severe, documented \[both threshold\], asymptomatic \[both threshold\], probable symptomatic and relative) per participant-year of exposure were reported. Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant wasn't capable of helping self. Documented symptomatic hypoglycemia: event in which typical SOH were accompanied by measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L(\<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L(\<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC \<=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC \>3.9 mmol/L (70 mg/dL).
| events per participant-year | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Any hypoglycemia | 103.18 | 97.09 |
| Severe hypoglycemia | 0.76 | 0.38 |
| Documented symptomatic hypoglycemia <= 3.9 mmol/L | 64.29 | 63.54 |
| Documented symptomatic hypoglycemia < 3.0 mmol/L | 27.72 | 25.70 |
| Asymptomatic hypoglycemia <= 3.9 mmol/L | 37.33 | 32.25 |
| Asymptomatic hypoglycemia < 3.0 mmol/L | 9.11 | 7.03 |
| Probable symptomatic hypoglycemia | 0.70 | 0.81 |
| Relative hypoglycemia | 0.09 | 0.12 |
An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the on-treatment period (from first injection of IMP up to 1 day after the last injection of IMP).
| Participants | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Any TEAEs | 25 | 47 |
| Any TESAEs | 5 | 5 |
Tmax was defined as the time taken to reach the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog.
| hours | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm) | 1.33 (0.30 to 3.25) | 1.00 (0.37 to 3.13) |
Collected over From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Switching: NovoLog/SAR341402 | 0/99 (0%) | 5/99 (5.1%) | 3/99 (3%) |
| Non-switching: NovoLog | 0/111 (0%) | 5/111 (4.5%) | 12/111 (10.8%) |
| Event | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 2/99 | 1/111 |
| Alcohol AbusePsychiatric disorders | 0/99 | 2/111 |
| SeizureNervous system disorders | 1/99 | 0/111 |
| ColitisGastrointestinal disorders | 1/99 | 0/111 |
| Accidental OverdoseInjury, poisoning and procedural complications | 1/99 | 0/111 |
| Gastroenteritis ViralInfections and infestations | 0/99 | 1/111 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 0/99 | 1/111 |
| Event | Switching: NovoLog/SAR341402 | Non-switching: NovoLog |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/99 | 6/111 |
| Upper Respiratory Tract InfectionInfections and infestations | 1/99 | 6/111 |
Analysis was performed on randomized population which included all participants who had a treatment kit number allocated and recorded in the interactive response technology (IRT) database, regardless of whether the treatment kit was used.
| Age, Continuous(years) | Switching: NovoLog/SAR341402 | Non-switching: NovoLog | Total |
|---|---|---|---|
| Mean | 43.8 ± 16.2 | 44.3 ± 15.8 | 44.1 ± 16.0 |
| Sex: Female, Male(Participants) | Switching: NovoLog/SAR341402 | Non-switching: NovoLog | Total |
|---|---|---|---|
| Female | 44 | 40 | 84 |
| Male | 60 | 66 | 126 |
| Race (NIH/OMB)(Participants) | Switching: NovoLog/SAR341402 | Non-switching: NovoLog | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 11 | 19 |
| White | 91 | 90 | 181 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 1 | 2 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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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