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Regular Human Insulin

Phase 1

Healthy | Small molecule | Other |MannKind Corporation|Last Updated: Sep 7, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment35

FDA Designations

No designations recorded

Clinical trial landscape

Regular Human Insulin · 1 trial · 1 indication

Phase 1 1
NCT01490762Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C InhalerHealthy
COMPLETED35 Analytics
PHASE1COMPLETED
Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler
Healthy
NCT0149076235
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Study Endpoints

Primary Endpoints

area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) post-dosing of a TI dose (10 U, 30 U, 60 U or 80U). Time points: 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180 and 240 minutes post-TI dosing
crossover 4 times over the course of up to 5 weeks

Secondary Endpoints

Area-under-the-serum insulin concentration versus time curve (AUC0-240min) for inhaled Technosphere Insulin (TI) compared to that of subcutaneous regular human insulin (RHI)
crossover 5 times over the course of up to 6 weeks
Area-under-the-serum glucose infusion rate (GIR AUC0-240min) for TI compared to AUC0-600min for RHI
crossover 5 times over the course of up to 6 weeks
Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations
crossover 5 times for up to 6 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Regular Human InsulinACTIVE_COMPARATORSubcutaneous injection
TI and Regular Human InsulinEXPERIMENTALAll subjects have 4 clamp procedures with 10, 30, 60,80 units of TI and 1 clamp with 15 IU Regular Human Insulin

Interventions

NameTypeDescription
Technosphere Insulin Inhalation Powder using the Gen2C inhalerDRUGInhalation Powder
Regular Human InsulinDRUGSubcutaneous injection
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men and women aged 18 to 55 years who are considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * Good venous access for blood draws * No smoking in the previous 6 months (including cigarettes, cigars, pipes) and negati...

Countries:United States
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Frequently asked questions about Regular Human Insulin

What is Regular Human Insulin used for?

Regular Human Insulin is an investigational drug being studied in healthy volunteers. It is a form of insulin intended for delivery via inhalation, using the Technosphere Insulin (TI) formulation with the Gen2C Inhaler. The drug is currently in Phase 1 clinical development.

Who makes Regular Human Insulin?

Regular Human Insulin is being developed by MannKind Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the safety and effects of this inhaled insulin product.

What phase is Regular Human Insulin in?

Regular Human Insulin is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and pharmacological effects in humans.

What clinical trials is Regular Human Insulin in?

Regular Human Insulin has one completed Phase 1 clinical trial registered as NCT01490762. This study evaluated the exposure and effects of multiple doses of Technosphere Insulin (TI) using the Gen2C Inhaler in healthy volunteers in the United States.

How does Regular Human Insulin work?

Regular Human Insulin is a form of insulin, a hormone that regulates glucose metabolism. It is delivered via inhalation using Technosphere technology, which allows insulin to be absorbed through the lungs. The drug is designed to mimic the body's natural insulin response.