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Technosphere Insulin using the Gen2C inhaler

Phase 1

Undisclosed | Small molecule | Other |MannKind Corporation|Trials 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

Technosphere Insulin using the Gen2C inhaler clinical trials

Technosphere Insulin using the Gen2C inhaler · 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
HealthyUnlock trial analytics

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 Technosphere Insulin using the Gen2C inhaler

What is Technosphere Insulin using the Gen2C inhaler?

Technosphere Insulin using the Gen2C inhaler is an inhaled formulation of insulin delivered as a powder through the Gen2C inhaler device. It is being developed by MannKind Corporation and has been studied in a Phase 1 clinical trial in healthy volunteers.

Who makes Technosphere Insulin using the Gen2C inhaler?

Technosphere Insulin using the Gen2C inhaler is developed by MannKind Corporation, which trades under the ticker MNKD. MannKind is the company responsible for the Technosphere inhalation technology platform.

What phase is Technosphere Insulin using the Gen2C inhaler in?

Technosphere Insulin using the Gen2C inhaler is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial has been completed.

What clinical trials is Technosphere Insulin using the Gen2C inhaler in?

Technosphere Insulin using the Gen2C inhaler has been evaluated in one completed Phase 1 trial, NCT01490762, titled "Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere Insulin (TI) Using the Gen2C Inhaler." The trial enrolled 35 healthy volunteers in the United States.