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MYL-1601D Product

Phase 3

Diabetes Mellitus, Type 1 | Small molecule | Metabolic |Viatris Inc.|Last Updated: Feb 25, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment478

FDA Designations

No designations recorded

Clinical trial landscape

MYL-1601D Product · 1 trial · 1 indication

Phase 3 1
NCT03760068Mylan Insulin Aspart StudyDiabetes Mellitus, Type 1
COMPLETED478 Analytics
PHASE3COMPLETED
Mylan Insulin Aspart Study
Diabetes Mellitus, Type 1
NCT03760068478
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Study Endpoints

Primary Endpoints

Treatment Emergent Antibody Response (TEAR)
Baseline to week 24

The number of subjects who were TEAR positive. TEAR is defined as either one of the following: 1. Subjects who are Anti-Drug Antibody (ADA) negative at baseline and become positive at any timepoint post baseline 2. Subjects who are ADA positive at baseline and demonstrate 4-fold increase in titer values at any timepoint post baseline visit.

Secondary Endpoints

Change in HbA1c From Baseline
Baseline to week 24
Change in Fasting Plasma Glucose From Baseline
Baseline to week 24
Change in Prandial Insulin Dose From Baseline
Baseline to week 24
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MYL-1601D Product (100 U/mL)ACTIVE_COMPARATOR -
FlexPen NovoLog® (100 U/mL)ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
MYL-1601D ProductDRUG(100 U/mL)
FlexPen NovoLog®DRUG(100 U/mL)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites158

Inclusion criteria 1. Written and signed informed consent. 2. Clinical diagnosis of type 1 diabetes mellitus for at least 6 months prior to screening. 3. Subject is able and willing to comply with the requirements of the study protocol. Exclusion Criteria 1. History or presence of a medical condi...

Countries:United States
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Frequently asked questions about MYL-1601D Product

What is MYL-1601D Product used for?

MYL-1601D Product is an investigational small molecule being developed for the treatment of Type 1 Diabetes Mellitus. It is currently in Phase 3 clinical development, though the single completed trial has not led to an approved indication. The drug is intended to address the metabolic needs of patients with this condition.

Who makes MYL-1601D Product?

MYL-1601D Product is being developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. Viatris is responsible for the clinical development and regulatory strategy for this investigational therapy targeting Type 1 Diabetes Mellitus.

What phase is MYL-1601D Product in?

MYL-1601D Product is in Phase 3 clinical development. A single Phase 3 trial has been completed, but the drug remains investigational and has not been approved by regulatory authorities. The completed study enrolled 478 participants with Type 1 Diabetes Mellitus.

What clinical trials is MYL-1601D Product in?

MYL-1601D Product has one completed Phase 3 trial registered as NCT03760068, titled "Mylan Insulin Aspart Study." This randomized, active-controlled study enrolled 478 adults aged 18 years and older with Type 1 Diabetes Mellitus in the United States. The trial is completed, and no active trials are currently listed.

Is MYL-1601D Product the same as insulin aspart?

The completed clinical trial for MYL-1601D Product is titled "Mylan Insulin Aspart Study," suggesting the product may be a form of insulin aspart. However, the drug name MYL-1601D Product is used in the trial registration, and no alternative names are provided in the available data.