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MYL-1501D product using manufacture process V

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment219

FDA Designations

No designations recorded

Clinical trial landscape

MYL-1501D product using manufacture process V · 1 trial · 1 indication

Phase 3 1
NCT03376789Mylan Insulin Glargine StudyDiabetes Mellitus, Type 1
COMPLETED219 Analytics
PHASE3COMPLETED
Mylan Insulin Glargine Study
Diabetes Mellitus, Type 1Unlock trial analytics

Study Endpoints

Primary Endpoints

Change in HbA1c
Baseline to Week 18

Change in HbA1c from baseline

Secondary Endpoints

Change in FPG
Baseline to Week 18
Change in Insulin Dose
Baseline to Week 18
Change in 8-point SMBG
Baseline to Week 18
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MYL-1501D (Process V Product)ACTIVE_COMPARATORMYL-1501D (Process V Product)
MYL-1501D (Process VI Product)ACTIVE_COMPARATORMYL-1501D (Process VI Product)

Interventions

NameTypeDescription
MYL-1501D product using manufacture process VDRUGMYL-1501D product using manufacture process V
MYL-1501D product using manufacture process VIDRUGMYL-1501D product using manufacture process VI
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites38

Inclusion Criteria: 1. Written and signed informed consent needs to be provided by subjects or their legal representatives before starting any protocol-specific procedures. 2. Male and female subjects between the ages of 18 to 65 years, both ages inclusive. 3. Subjects with an established diagnosis...

Countries:United States
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Frequently asked questions about MYL-1501D product using manufacture process V

What is MYL-1501D product using manufacture process V used for?

MYL-1501D product using manufacture process V is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.

Who makes MYL-1501D product using manufacture process V?

MYL-1501D product using manufacture process V is being developed by Viatris Inc., a company traded on the stock exchange under the ticker symbol VTRS. The drug is currently in Phase 3 clinical trials for Type 1 Diabetes Mellitus.

What phase is MYL-1501D product using manufacture process V in?

MYL-1501D product using manufacture process V is in Phase 3 clinical development. It is an investigational drug for Type 1 Diabetes Mellitus and has not yet been approved by regulatory agencies. One Phase 3 trial has been completed.

What clinical trials is MYL-1501D product using manufacture process V in?

MYL-1501D product using manufacture process V has one completed Phase 3 clinical trial, identified as NCT03376789, titled "Mylan Insulin Glargine Study." This randomized, double-blind, active-controlled trial enrolled 219 participants with Type 1 Diabetes Mellitus in the United States.

Is MYL-1501D product using manufacture process V FDA approved?

MYL-1501D product using manufacture process V is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for Type 1 Diabetes Mellitus. The drug has completed one Phase 3 trial but has not yet received regulatory approval.