Recent Updates
Recently added Catalysts

Technosphere Insulin 10U+ 20U

Phase 1

Undisclosed | Small molecule | Other |MannKind Corporation|Trials Updated: Dec 12, 2014

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Technosphere Insulin 10U+ 20U clinical trials

Technosphere Insulin 10U+ 20U · 1 trial · 1 indication

Phase 1 1
NCT01902121Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 CartridgeHealthy Volunteers
COMPLETED40 Analytics
PHASE1COMPLETED
Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Area-under-the-serum insulin concentration versus time curve (AUC0-240min
0, 5, 10, 15, 20, 25, 30, 45, 60, 75, 90, 120, 150, 210 and 240 minutes post-TI dosing
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TI 30 units (10 unit + 20 unitEXPERIMENTALTechnosphere® Insulin 30 units given as 2 cartridges: one 10 unit cartridge + one 20 unit cartridge
TI 30 units (30 unit cartridgeEXPERIMENTALTechnosphere® Insulin 30 units given as one 30 unit cartridge

Interventions

NameTypeDescription
Technosphere® Insulin 10U + 20UDRUGInhaled Insulin
Technosphere® Insulin 30UDRUGInhaled Insulin
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Men and women aged 18 to 45 years, considered healthy based on screening physical examination, medical history, clinical chemistry, and urinalysis * No smoking in the past 6 months (including cigarettes, cigars, and pipes) * Urine cotinine testing \< 100 ng/mL * Body mass inde...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Technosphere Insulin 10U+ 20U

What is Technosphere Insulin 10U+ 20U?

Technosphere Insulin 10U+ 20U is an investigational inhaled insulin product developed by MannKind Corporation. It is a small molecule formulation studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease indications studied for this product have not been disclosed.

Who makes Technosphere Insulin 10U+ 20U?

Technosphere Insulin 10U+ 20U is made by MannKind Corporation, which trades on the Nasdaq under the ticker MNKD. MannKind is the developer of the Technosphere insulin delivery technology used in this product.

What phase is Technosphere Insulin 10U+ 20U in?

Technosphere Insulin 10U+ 20U is in Phase 1 clinical development. It is an investigational product and is not approved by the FDA. One Phase 1 trial has been completed, and no active trials are currently listed for this specific product.

What clinical trials is Technosphere Insulin 10U+ 20U in?

Technosphere Insulin 10U+ 20U has been studied in one completed Phase 1 trial, NCT01902121, titled "Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge." The trial enrolled 40 healthy adult volunteers in the United States and used a controlled, randomized design.