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Mylan's insulin glargine

Phase 3

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Viatris Inc.|Last Updated: Mar 3, 2022

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment127
FDA Designations
No designations recorded
Clinical trial landscape

Mylan's insulin glargine · 3 trials · 3 indications

Phase 3 3
NCT02666430Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) PatientsType 1 Diabetes Mellitus
COMPLETED127 Analytics
NCT02227875Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)Type 2 Diabetes
COMPLETED560 Analytics
NCT02227862Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)Type 1 Diabetes
COMPLETED558 Analytics
PHASE3COMPLETED
Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
Type 1 Diabetes Mellitus
NCT02666430127
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PHASE3COMPLETED
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 2 Diabetes Mellitus Patients (INSTRIDE 2)
Type 2 Diabetes
NCT02227875560
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PHASE3COMPLETED
Non-inferiority Study to Compare the Efficacy and Safety of Mylan's Insulin Glargine With Lantus® in Type 1 Diabetes Mellitus Patients (INSTRIDE 1)
Type 1 Diabetes
NCT02227862558
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Study Endpoints
Primary Endpoints
Change in Hemoglobin A1c (HbA1c) From Baseline
Baseline to 36 weeks
Change in HbA1c From Baseline to 24 Weeks
24 weeks
Secondary Endpoints
Change From Baseline in Fasting Plasma Glucose
Baseline to 36 weeks
Overall Average of Self-monitoring Blood Glucose (SMBG) Change From Baseline
Baseline to 36 weeks
Change From Baseline Total Daily Insulin Dose
Baseline to 36 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mylan's insulin glargineEXPERIMENTALPatients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Lantus®ACTIVE_COMPARATORPatients will be administered either Mylan insulin glargine or Lantus® subcutaneously, once daily in combination with lispro and titrated based on blood glucose readings per standard of care for a total of thirty-six (36) weeks, split into three cycles of twelve (12) weeks each.
Interventions
NameTypeDescription
Mylan's insulin glargineDRUG -
Lantus®DRUG -
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Eligibility Criteria
Age Range18 Years to 66 Years
SexALL
Healthy VolunteersYes
Study Sites81

Inclusion Criteria: 1. Patients who have completed the 52-week treatment period (irrespective of their age at the completion of MYL-GAI-3001 trial) of the MYL-GAI-3001 trial and were assigned to Lantus® in that study. 2. Patients or their legal representatives must give written and signed informed ...

Countries:United StatesCanadaCzechiaEstoniaGermanyHungaryLatviaSlovakiaJordanSouth AfricaSouth KoreaTaiwanRomaniaUnited Kingdom
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