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Technosphere/Insulin

Phase 2

Diabetes Mellitus, Type 2 | Small molecule | Metabolic |MannKind Corporation|Trials Updated: Dec 17, 2013

Technosphere/Insulin development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jan 2007

Technosphere/Insulin target and mechanism

ModalitySmall molecule

Also known as Technosphere Inhalation Powder (FDKP), Technosphere, Technosphere Inhalation Powder, Technosphere Powder

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials3
Total Enrollment91

FDA Designations

No designations recorded

Technosphere/Insulin clinical trials

Technosphere/Insulin · 3 trials · 5 indications

Phase 2 1Phase 1 2
NCT00419302To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.Diabetes Mellitus, Type 2
COMPLETED16 Analytics
PHASE2COMPLETED
To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.
Diabetes Mellitus, Type 2Unlock trial analytics

Study Endpoints

Primary Endpoints

Glycemic response to a meal challenge
Differences in exposure to fumaryl diketopiperazine (FDKP)
14 days
To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP
30 days

Secondary Endpoints

Serum insulin concentrations measured for Technosphere/Insulin administration and subcutaneous insulin administration across 13 time points over a 270 minute period
Safety variables
Additional safety parameters
14 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
T Inhalation powder in diabetic subjs w/ normal renal funcEXPERIMENTALT inhalation powder in diabetic subjects with normal renal function, Single dose, 30 units
T Inhalation powder diabetic subj w/mild or moderate nephropEXPERIMENTALT Inhalation powder in diabetic subjects w/mild or moderate nephropathy - Single dose, 30 units
Non-Diabetic Subj. w/o COPDEXPERIMENTALSingle dose, 30 units
Non-Diabetic Subj. with COPDEXPERIMENTALSingle dose, 30 units

Interventions

NameTypeDescription
Technosphere/InsulinDRUG -
Technosphere Inhalation PowderDRUGTechnosphere Inhalation Powder
Technosphere®/InsulinDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Clinical diagnosis of type 2 diabetes mellitus. * Current regimen of intensified insulin therapy for at least 6 months. * Body Mass Index less than 35 kg/m2. * HbA1c less than or equal to 9%. * Non-smoker for at least 2 years. * If medications in addition to insulin are taken ...

Countries:GermanyUnited StatesAustriaNetherlandsUnited Kingdom
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Frequently asked questions about Technosphere/Insulin

What is Technosphere/Insulin?

Technosphere/Insulin is an inhaled dry powder insulin formulation developed by MannKind Corporation. It is delivered as Technosphere Inhalation Powder and has been studied in clinical trials for type 2 diabetes mellitus, chronic obstructive pulmonary disease (COPD), and mild nephropathy. It remains an investigational product in clinical development.

What is Technosphere/Insulin used for?

Technosphere/Insulin has been studied for type 2 diabetes mellitus, chronic obstructive pulmonary disease (COPD), and mild nephropathy. Trials have evaluated insulin absorption after inhalation in non-diabetic patients with and without COPD, and compared inhaled insulin with subcutaneously injected insulin in type 2 diabetes.

Who makes Technosphere/Insulin?

Technosphere/Insulin is developed by MannKind Corporation, which trades under the ticker MNKD. MannKind is the sponsor of the clinical trials evaluating the Technosphere Inhalation Powder formulation across diabetes and respiratory conditions.

What phase is Technosphere/Insulin in?

Technosphere/Insulin is in Phase 1 clinical development. It is an investigational product and has not been approved by the FDA. Completed studies include Phase 1 trials in COPD and mild nephropathy, along with a Phase 2 trial in type 2 diabetes mellitus.

What clinical trials is Technosphere/Insulin in?

Technosphere/Insulin has been evaluated in completed trials including NCT01021891, a Phase 1 study of insulin blood levels after inhalation in non-diabetic patients with and without COPD, and NCT00626249, a Phase 1 study in diabetic subjects with mild or moderate kidney disease. A Phase 2 trial, NCT00419302, compared inhaled with injected insulin in type 2 diabetes.

Is Technosphere/Insulin the same as Technosphere Inhalation Powder?

Yes. Technosphere/Insulin is also known as Technosphere Inhalation Powder, Technosphere Inhalation Powder (FDKP), Technosphere, and Technosphere Powder. These names refer to the same inhaled dry powder insulin formulation developed by MannKind Corporation.