| Trial ID: | L6154 |
| Source ID: | NCT03874715
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| Associated Drug: |
Insulin Aspart Sar341402
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| Title: |
Comparison of SAR341402 to NovoLog in Adult Patients With Type 1 Diabetes Mellitus Also Using Insulin Glargine
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| Acronym: |
GEMELLI X
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| Status: |
COMPLETED
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| Study Results: |
YES
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| Results: |
https://ClinicalTrials.gov/show/NCT03874715/results
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| Conditions: |
Type 1 Diabetes Mellitus
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| Interventions: |
DRUG: Insulin Aspart SAR341402|DRUG: Insulin Aspart|DRUG: Insulin glargine U100
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| Outcome Measures: |
Primary: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Measurable Timepoint (AUClast) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm), AUClast was defined as area under the plasma concentration versus time curve from time zero to last measurable timepoint. Insulin aspart was the active ingredient of SAR341402 and NovoLog., 0 hour (hr)(Pre-dose), 10, 20, 30, 40 & 50 minutes (min), 1hr, 1hr-10, 20, 30, 40 & 50min, 2hr, 2hr-15, 30 & 45min, 3hr, 3hr-15, 30 & 45min, 4hr, 4hr-20 & 40min, 5hr, 5hr-20 & 40min, 6hr, 6hr-30min, 7hr, 7hr-30min & 8hr post-dose on Day 112|Pharmacokinetics: Area Under the Plasma Concentration Versus Time Curve (AUC) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm), AUC was defined as area under the concentration versus time curve. Insulin aspart is the active ingredient of SAR341402 and NovoLog., 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2 hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112|Pharmacokinetics: Maximum Observed Plasma Concentration (Cmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm), Cmax was defined as the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog., 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112 | Secondary: Number of Participants With Treatment-emergent Anti-Insulin Aspart Antibodies (AIAs), AIA was categorized as: treatment-induced AIA, treatment-boosted AIA, and treatment-emergent AIA. Treatment-induced AIAs: participants who developed AIA following investigational medicinal product (IMP) administration (participants with at least one positive AIA sample at any time during on-treatment period, in those participants without pre-existing AIA or with missing Baseline sample). Treatment-boosted AIAs: participants with pre-existing AIAs that were boosted to a significant higher titer following IMP administration (participants with at least one AIA sample with at least a 4-fold increase in titers compared to Baseline value at any time during on-treatment period, in those participants with pre-existing AIA). Participants with treatment-emergent AIA were defined as participants with treatment-induced, or treatment-boosted AIAs. On-treatment period was defined as the time from the first injection of IMP up to the last injection of IMP + 1 day., From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)|Number of Participants With at Least One Hypoglycemic Event, Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant was not capable of helping self. Documented symptomatic hypoglycemia: event in which typical symptoms of hypoglycemia (SOH) were accompanied by measured plasma glucose concentration (PGC) less than or equal to (\<=) 3.9 millimoles per liter (mmol/L)(\<70 milligrams per deciliter \[mg/dL\]) or \<3.0 mmol/L(\<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and with measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L (\<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC \<=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC greater than (\>) 3.9 mmol/L (70 mg/dL)., From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)|Number of Hypoglycemic Events Per Participant-year, Number of hypoglycemia events (any, severe, documented \[both threshold\], asymptomatic \[both threshold\], probable symptomatic and relative) per participant-year of exposure were reported. Severe hypoglycemia: event in which participant required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions, because participant wasn't capable of helping self. Documented symptomatic hypoglycemia: event in which typical SOH were accompanied by measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L(\<54 mg/dL). Asymptomatic hypoglycemia: event without SOH and measured PGC of \<=3.9 mmol/L (\<70 mg/dL) or \<3.0 mmol/L(\<54 mg/dL). Probable symptomatic hypoglycemia: event with SOH not accompanied by plasma glucose determination but was presumably caused by PGC \<=3.9 mmol/L (70 mg/dL). Relative hypoglycemia: event with SOH but with measured PGC \>3.9 mmol/L (70 mg/dL)., From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs), An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were defined as any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/ incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the on-treatment period (from first injection of IMP up to 1 day after the last injection of IMP)., From first injection of IMP (Day 1) up to 1 day after the last injection of IMP (i.e., up to Day 113)|Pharmacokinetics: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Insulin Aspart Following Administration of Either SAR341402 (Switching Arm) or NovoLog (Non-switching Arm), Tmax was defined as the time taken to reach the maximum observed plasma concentration. Insulin aspart is the active ingredient of SAR341402 and NovoLog., 0 hr (pre-dose), 10, 20, 30, 40 & 50 min, 1 hr, 1 hr-10, 20, 30, 40 & 50 min, 2 hr, 2hr-15, 30 & 45 min, 3 hr, 3 hr-15, 30 & 45 min, 4 hr, 4 hr-20 & 40 min, 5 hr, 5 hr-20 & 40 min, 6 hr, 6 hr-30 min, 7 hr, 7 hr-30 min & 8 hr post-dose on Day 112
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| Sponsor/Collaborators: |
Sponsor: Sanofi
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
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| Enrollment: |
210
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2019-03-11
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| Completion Date: |
2020-07-08
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| Results First Posted: |
2023-07-21
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| Last Update Posted: |
2024-04-17
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| Locations: |
Investigational Site Number 8400014, Concord, California, 94520, United States|Investigational Site Number 8400001, Temecula, California, 92591, United States|Investigational Site Number 8400015, Ventura, California, 93003, United States|Investigational Site Number 8400010, Aurora, Colorado, 80045, United States|Investigational Site Number 8400029, Waterbury, Connecticut, 06708-3346, United States|Investigational Site Number 8400038, Doral, Florida, 33166, United States|Investigational Site Number 8400030, Miami, Florida, 33165, United States|Investigational Site Number 8400032, New Port Richey, Florida, 34652, United States|Investigational Site Number 8400026, Ocoee, Florida, 34761, United States|Investigational Site Number 8400033, Palm Harbor, Florida, 34684, United States|Investigational Site Number 8400012, Atlanta, Georgia, 30318, United States|Investigational Site Number 8400005, Columbus, Georgia, 31904, United States|Investigational Site Number 8400009, Roswell, Georgia, 30076, United States|Investigational Site Number 8400019, Crystal Lake, Illinois, 60012, United States|Investigational Site Number 8400028, Des Moines, Iowa, 50314, United States|Investigational Site Number 8400018, Lexington, Kentucky, 40503, United States|Investigational Site Number 8400023, Baltimore, Maryland, 21237, United States|Investigational Site Number 8400003, Rockville, Maryland, 20852-4267, United States|Investigational Site Number 8400013, Waltham, Massachusetts, 02453, United States|Investigational Site Number 8400004, Flint, Michigan, 48532, United States|Investigational Site Number 8400021, Kansas City, Missouri, 64111, United States|Investigational Site Number 8400031, Washington, Missouri, 63090, United States|Investigational Site Number 8400036, Omaha, Nebraska, 68114, United States|Investigational Site Number 8400017, Las Vegas, Nevada, 89148, United States|Investigational Site Number 8400007, New York, New York, 10001, United States|Investigational Site Number 8400006, Morehead City, North Carolina, 28557, United States|Investigational Site Number 8400035, Rocky Mount, North Carolina, 27804, United States|Investigational Site Number 8400034, Jefferson City, Tennessee, 37760, United States|Investigational Site Number 8400040, Dallas, Texas, 75235, United States|Investigational Site Number 8400042, El Paso, Texas, 79935, United States|Investigational Site Number 8400027, Houston, Texas, 77079, United States|Investigational Site Number 8400016, Mesquite, Texas, 75149, United States|Investigational Site Number 8400041, Waco, Texas, 76710, United States
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| URL: |
https://clinicaltrials.gov/show/NCT03874715
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