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Technosphere Insulin

Phase 3

Type 1 Diabetes Mellitus | Small molecule | Metabolic |MannKind Corporation|Last Updated: Jul 7, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment635
FDA Designations
No designations recorded
Clinical trial landscape

Technosphere Insulin · 21 trials · 19 indications

Phase 3 7Phase 2 9Phase 1 5
NCT01451398Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes MellitusType 2 Diabetes
COMPLETED353 Analytics
NCT01445951Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment PeriodType 1 Diabetes Mellitus
COMPLETED518 Analytics
NCT00308308Efficacy & Safety of Inhaled Insulin in Type 1 DiabetesDiabetes, Type I
COMPLETED589 Analytics
NCT00309244Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-upDiabetes Type 2
COMPLETED677 Analytics
NCT00539890Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes MellitusDiabetes Type 2
COMPLETED- Analytics
NCT00308737Safety of Inhaled Insulin With Type 1 and Type 2 DiabetesDiabetes, Type 1
COMPLETED2,053 Analytics
NCT00332488Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2
COMPLETED547 Analytics
PHASE3COMPLETED
Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes
NCT01451398353
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PHASE3COMPLETED
Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period
Type 1 Diabetes Mellitus
NCT01445951518
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PHASE3COMPLETED
Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes
Diabetes, Type I
NCT00308308589
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PHASE3COMPLETED
Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere/Insulin Versus Subcutaneous Premixed Insulin Therapy Over a 52-Week Treatment Period and a 4-Week Follow-up
Diabetes Type 2
NCT00309244677
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PHASE3COMPLETED
Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
Diabetes Type 2
NCT00539890-
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PHASE3COMPLETED
Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes
Diabetes, Type 1
NCT003087372,053
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PHASE3COMPLETED
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Diabetes Mellitus, Type 2
NCT00332488547
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Study Endpoints
Primary Endpoints
Change From Baseline to Week 24 in HbA1c
Baseline to Week 24

Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24

Compare the Mean Change From Baseline to Week 52 in HbA1c
Baseline to Week 52
Change From Baseline in HbA1c to Week 52
Baseline to Week 52
Mean change in HbA1c from baseline to treatment week 24
24 weeks
Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual Care
Baseline to Month 24

Change from Baseline to End of Study in FEV1 by MMRM

FEV1 Decrease of ≥ 15% From Baseline Value at Last Measurement for TI vs Usual Care
Baseline to Month 24

FEV1 decrease of ≥ 15% from Baseline value at last measurement

Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
Baseline to Week 12
Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%
13 weeks

Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit

Post-prandial AUC120
3 hours from start of meal

3-hour post-prandial (PP) area under the curve \>120 mg/dL (AUC120)

Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360
0 to 360 minutes post-dose

Dose-normalized baseline-corrected area under the serum insulin vs. time curve

Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Cmax.
0 to 360 minutes post-dose

Maximum observed baseline-corrected serum insulin concentration

Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin Tmax
0 to 360 minutes post-dose
Relative Bioavailability of 30 U of TI (TI Inhalation Powder B) Versus 10 U of sc Insulin Lispro
0 to 360 minutes post-dose

Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)

Time to Minimum Endogenous Glucose Production (EGP) - Meal Challenge
0-480 minutes

Time to minimum EGP post dose

Minimum EGP - Meal Challenge
0-480 minutes

Minimum calculated EGP per subject as change from baseline

EGP AOC0-480 - Meal Challenge
0-480 minutes

EGP area over the curve from 0 to 480 minutes postdose

Change in blood glucose following a standard meal
0-300 minutes
To compare the relative bioavailability and bioeffect of TI Inhalation Powder in subjects with type 2 diabetes who smoke and who do not smoke to determine relative insulin bioavailability
15 to 52 days
HbA1c change from baseline (week 6) to end of treatment (week 17)
measured from week 6 (baseline) to week 17
Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline.
at weeks 4, 6, 11 and 17

Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration

Area under the plasma glucose concentration versus time (AUCglucose) compared to week 6 (baseline)
at weeks 4, 6, 11 and 17

Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration

Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulin
crossover approx every 2 weeks for up to 10 weeks
Area under the glucose infusion rate (GIR AUC0-540 min) for Technosphere® Insulin compared to regular human insulin
crossover approx every 2 weeks for up to 10 weeks
Intra-patient and inter-patient comparison of CV % between treatments was based on a t-test.for bioavailability (ie, SI AUC0-540 min) & bioeffect (ie, GIR AUC0-540 min)
crossover approx every 2 weeks for up to 10 weeks
HbA1c change from baseline (week 2) to end of treatment (week 12)
12 weeks
PK measures for TI Inhalation Powder (20U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints: 0, 3, 6, 9, 12, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 240, 300 and 360 minutes post-TI dosing
Crossover 1 time within 3 - 10 days
PK measures for RAA (8U) as measured by area under the concentration-time curve (AUC 0-360) - timepoints 0, 5, 10, 15, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180, 210, 240, 270, 300 and 360 minutes post-RAA dosing
Crossover 1 time within 3 - 10 days
The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as delivered
0-120 minutes
PK parameters of serum insulin
0-360 min
AUCF 0-360 min of serum insulin
0-360 min
Dose-corrected area-under-the serum insulin concentration vs. time curve for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
crossover every 3-28 days for up to 20 weeks
Area under the glucose infusion rate for inhaled TI and subcutaneous RHI at timepoints -120, -90, -60, 0, 1, 3, 7, 12, 20, 30, 45, 60 and 90 minutes, and 2, 3, 4, 5 and 6 hours relative to treatment
crossover every 3-28 days for up to 20 weeks
Secondary Endpoints
Proportion of Responders Achieving HbA1c <= 7.0%
Week 24
Proportion of Responders Achieving HbA1c <= 6.5%
Week 24
FPG Change From Baseline to Week 24
Baseline to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TI inhalation powderEXPERIMENTALTechnosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs
Technosphere powderPLACEBO_COMPARATORTechnosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs
Technosphere® Insulin with MedTone C InhalerEXPERIMENTALSubjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry
Aspart GroupACTIVE_COMPARATORSubjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry
Technosphere ® Insulin-Gen2 GroupEXPERIMENTALSubject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry
1EXPERIMENTALTechnosphere Insulin
2ACTIVE_COMPARATORRapid-acting analogue insulin plus basal insulin glargine
TI + Insulin glargineEXPERIMENTALTechnosphere® Insulin Inhalation Powder + insulin glargine
BPR 70/30ACTIVE_COMPARATOR70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Usual careOTHERUsual care
Non-diabetesNO_INTERVENTIONSubjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group)
3EXPERIMENTALTechnosphere \& Metformin
Afrezza (Technosphere Insulin) + Basal InsulinEXPERIMENTALIndividualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks.
technosphere insulin (TI)EXPERIMENTALAll participants will ingest one standardized meal using technosphere insulin to manage their blood glucose
Rapid-acting insulin analogNO_INTERVENTIONAll participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose
1: TI Inhalation Powder AEXPERIMENTALTechnosphere® Insulin Inhalation Powder, two 15 U cartridges
2: TI Inhalation Powder BEXPERIMENTALTechnosphere® Insulin Inhalation Powder, one 30 U cartridge
3: RAA PopulationEXPERIMENTALRapid Acting Analogue subjects received 10 IU sc Insulin Lispro
SmokersEXPERIMENTAL -
Non-SmokersEXPERIMENTAL -
Technosphere InsulinEXPERIMENTAL -
Technosphere Inhalation PowderPLACEBO_COMPARATOR -
ActrapidACTIVE_COMPARATORSubcutaneous regular human insulin
Technosphere Insulin Inhalation PowderEXPERIMENTAL -
RAAACTIVE_COMPARATORRapid Acting Analog
Cohort 1EXPERIMENTAL -
Cohort 2EXPERIMENTAL -
Technosphere insulin inhalation system, 25 unitsEXPERIMENTAL -
Technosphere insulin inhalation system, 50 unitsEXPERIMENTAL -
Technosphere insulin inhalation system, 100 unitsEXPERIMENTAL -
Subcutaneous regular human insulinACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Technosphere® InsulinDRUGTechnosphere® Insulin Inhalation Powder
Technosphere PowderDRUGPlacebo Comparator
Technosphere® Insulin with MedTone C InhalerDRUGInhalation Powder and injectable insulin
Technosphere ®Insulin with Gen2 InhalerDRUGInhalation Powder and injectable insulin
Insulin Aspart in combination with a basal insulinDRUGInjectable insulin
Technosphere InsulinDRUGInhalation, 15U/30U
Active comparatorDRUGsc injectable insulin
Technosphere® Insulin Inhalation PowderDRUGInhalation, 15U/30U
70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)DRUGBPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc
Usual CareDRUGSubjects will receive antidiabetes treatment at the discretion of their physicians
Metformin & SecretagoguesDRUGMetformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
Technosphere Insulin & MetforminDRUGTechnosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
Basal insulinDRUGsubcutaneously-injected basal insulin
Inhaled Technosphere InsulinDRUGPatients will receive TI (Afrezza) to be compared to RAA following a breakfast meal
Technosphere Insulin® Inhalation PowderDRUGTI Inhalation Powder, one 30 U cartridge
RAA PopulationDRUGRAA Population: All subjects received a single 10 IU sc injection of insulin lispro.
Technosphere Insulin Inhalation PowderDRUG30U
Technosphere PlaceboDRUGTechnosphere Inhalation Powder
ActrapidDRUG24IU
Rapid Acting AnalogDRUGSubcutaneous Injection
Technosphere Insulin (TI) Inhalation PowderDRUG3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin.
Albuterol (Salbutamol)DRUG2 puff= 200ug total dose
FluticasoneDRUG2 puffs= 500ug total dose
Salbutamol (Albuterol)DRUG2 puff = 200 mcg total dose
Methacholine chlorideDRUG5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9%
Regular human insulinDRUG -
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites76

Inclusion Criteria: * HbA1c \> or = to 7.5% and \< or = to 10.0% * Body mass index (BMI) \< or = to 45 kg/m2 * Non smoker for at least 6 months before Screening * Clinical diagnosis of type 2 diabetes mellitus for more than 12 months * Currently receiving as diabetes treatment only metformin or 2 o...

Countries:United StatesBrazilRussiaUkraineArgentinaCanadaChileMexicoPolandSpainUnited KingdomCzechiaGermany
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Recent Changes (Last 90 Days)
LOWJul 7, 2026NCT07224321lastUpdatePostDate: changed
LOWJul 7, 2026NCT07224321lastUpdatePostDate: changed
LOWJun 16, 2026NCT07224321lastUpdatePostDate: changed
LOWJun 16, 2026NCT07224321lastUpdatePostDate: changed
LOWJun 16, 2026NCT07224321lastUpdatePostDate: changed
LOWMay 26, 2026NCT06535789primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT07224321primaryCompletionDate: changed
LOWMay 24, 2026NCT06535789studyFirstPostDate: changed
LOWMay 24, 2026NCT07224321studyFirstPostDate: changed