Recent Updates
Recently added Catalysts

Technosphere/Insulin

Phase 2

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

Technosphere/Insulin · 2 trials · 2 indications

Phase 2 1Phase 1 1
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 2
NCT0041930216
Unlock trial analytics

Study Endpoints

Primary Endpoints

Glycemic response to a meal challenge
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
Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I
30 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Non-Diabetic Subj. w/o COPDEXPERIMENTALSingle dose, 30 units
Non-Diabetic Subj. with COPDEXPERIMENTALSingle dose, 30 units

Interventions

NameTypeDescription
Technosphere/InsulinDRUG -
Technosphere®/InsulinDRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about Technosphere/Insulin

What is Technosphere used for?

Technosphere is an inhaled insulin delivery technology being studied for use in Type 2 Diabetes Mellitus, as well as in healthy subjects, and in patients with mild nephropathy, moderate nephropathy, or chronic obstructive pulmonary disease (COPD). It is an investigational small molecule product developed by MannKind Corporation.

Who makes Technosphere?

Technosphere is being developed by MannKind Corporation, a biopharmaceutical company traded under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the inhaled insulin formulation in various patient populations.

What phase is Technosphere in?

Technosphere is in Phase 1 clinical development. The most recent trials listed are Phase 1 studies, including one completed trial in healthy subjects and another in diabetic patients with kidney disease. Earlier Phase 2 studies have also been completed.

What clinical trials is Technosphere in?

Technosphere has been studied in several completed trials, including NCT00419302 in Type 2 Diabetes, NCT00626249 in diabetic patients with kidney disease, NCT00721344 in healthy subjects, and NCT01021891 in patients with COPD. All trials listed are completed.

Is Technosphere FDA approved?

Technosphere is not FDA approved. It is an investigational product still in clinical development, with all listed trials completed. No approval status has been granted based on the available clinical trial information.