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Clinical trials
catalyst calendar across sponsors →Studies where MNKD is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
53 interventional · 3 observational · 1 expanded access · 16 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary FibrosisNCT07679893Safety and EfficacyRandomized · Quadruple-masked · Treatment | Phase 2 | Recruiting | Drug: Nintedanib Dry Powder Inhalation, Placebo | Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF) | 210 | 2028-01-30 | in 529 d | 2026-07-24 |
| INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 DiabetesNCT07224321Percentage of participants with Continuous Glucose Meter (CGM) measured time in range (TIR) ≥70%Open-label · Treatment | Phase 2 | Recruiting | Drug: Technosphere Insulin, Technosphere Insulin, Basal insulin | Type 1 Diabetes Mellitus | 100 | Mar 2027 | ≤ 224 d | 2026-08-13 |
| A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy VolunteersNCT06532942(Part A) Incidence of inhaled intolerabilityRandomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: (Part A) MKND-201, Placebo, (Part B) MKND-201 | Healthy Volunteers | 40 | 2024-10-31 | — | 2024-08-06 |
| A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary FibrosisNCT07344558(Cohort 1) Events of BronchospasmRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: MNKD-201(Nintedanib DPI), Placebo | Idiopathic Pulmonary Fibrosis (IPF) | 27 | 2026-06-17actual | — | 2026-07-22 |
| ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation SuspensionNCT06418711(Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for MAC) by the end of Month 6Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Futility | Drug: Clofazimine Inhalation Suspension, Placebo | MAC Lung Disease, Treatment Refractory MAC Lung Disease, Mycobacterium Infections, Nontuberculous | 132 | 2025-11-10actual | — | 2025-11-12 |
| Afrezza® INHALE-1 Study in PediatricsNCT04974528Change in HbA1cRandomized · Open-label · Treatment | Phase 3 | Completed | Biological: Afrezza, Rapid-acting Insulin Analog, Basal Insulin | Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 | 319 | 2024-10-03actual | — | 2025-05-06 |
| INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 DiabetesNCT05904743Change in glycated hemoglobin (HbA1c)Randomized · Open-label · Treatment | Phase 4 | Completed | Biological: Afrezza, insulin degludec, Rapid-acting Insulin Analog, Basal Insulin | Diabetes Mellitus, Type 1 | 141 | 2024-03-26actual | — | 2024-08-09 |
| Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 DiabetesNCT05243628results2024-10-18Change in HbA1cRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 4 | Completed | Biological: Afrezza (insulin human) Inhalation Powder, insulin degludec · Device: Continuous Subcutaneous Insulin Infusion (CSII) pump with Automatic Insulin Delivery (AID) | Type 1 Diabetes | 33 | 2022-10-17actual | — | 2025-04-08 |
| Afrezza® Dosing Optimization StudyNCT04849845results2023-09-18Post-prandial Glucose ExcursionOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 4 | Completed | Combination product: Afrezza Dose 1, Afrezza Dose 2 | Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 | 20 | 2021-05-28actual | — | 2023-09-18 |
| Afrezza Safety and Pharmacokinetics Study in Pediatric PatientsNCT02527265results2021-04-06Insulin Maximum Observed Concentration (Cmax)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Biological: Afrezza | Type 1 Diabetes Mellitus | 30 | 2020-03-17actual | — | 2021-04-06 |
| Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal VolunteersNCT03464864Incidence and severity of treatment-related adverse events (safety and tolerability) of single ascending doses of Treprostinil Inhalation PowderNon-randomized · Open-label · Other | Phase 1 | Completed | Drug: Treprostinil Inhalation Powder | Pulmonary Arterial Hypertension | 36 | 2018-06-05actual | — | 2018-10-30 |
| PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM)NCT02485327Assessment of PK parameter: area under the serum insulin concentration time curve from time 0 to 8H (INS-AUC0-8H)Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere Insulin SAR439065 Afrezza® | Type 1 Diabetes Mellitus | 22 | Nov 2015actual | — | 2017-03-15 |
| Single Dose Clamp Study to Evaluate Concentration-time Profile and Metabolic Activity of 3 Dose Levels of Afrezza and 3 Dose Levels of Insulin Lispro in Patients With Type 1 Diabetes MellitusNCT02470637Assessment of PD parameter: Area under the glucose infusion rate curve within 24 hours after administration of the investigational medicinal product or until administration of rescue insulin (GIR-AUC0-end)Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: SAR439065, Insulin lispro | Type 1 Diabetes Mellitus | 30 | Sep 2015actual | — | 2017-04-13 |
| Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation PowderNCT01798914expanded access | — | No longer available | Drug: Technosphere Insulin Inhalation Powder | Type 1 Diabetes, Type 2 Diabetes | — | Apr 2015actual | — | 2016-01-20 |
| Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary DiseaseNCT00642616results2016-02-15Change in Post-bronchodilator FEV1 From Baseline to Week 52Randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Terminated upon recommendation of the Data Safety Monitoring Board (DSMB) | Drug: Technosphere® Insulin, Usual Care | Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Moderate Chronic Obstructive Pulmonary Disease, Asthma | 34 | Nov 2014actual | — | 2017-04-14 |
| Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different SuppliersNCT01982604AUC (area-under-the-serum-insulin concentration time curve) 0 - 240 minutesRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: TI-Inhalation Powder A, TI-Inhalation Powder B | Healthy Volunteers | 38 | Feb 2014actual | — | 2014-10-02 |
| Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 CartridgeNCT01902121Area-under-the-serum insulin concentration versus time curve (AUC0-240minRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere® Insulin 10U + 20U, Technosphere® Insulin 30U | Healthy Volunteers | 40 | Nov 2013actual | — | 2014-12-12 |
| Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes MellitusNCT01451398results2014-10-17Change From Baseline to Week 24 in HbA1cRandomized · Double-masked · Treatment | Phase 3 | Completed | Drug: Technosphere® Insulin, Technosphere Powder | Type 2 Diabetes | 353 | Jun 2013actual | — | 2014-10-17 |
| Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment PeriodNCT01445951results2014-10-22Change From Baseline to Week 24 in HbA1cRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler, Insulin Aspart in combination with a basal insulin | Type 1 Diabetes Mellitus | 518 | May 2013actual | — | 2014-10-22 |
| Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 DiabetesNCT01544881PK 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 dosingRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Technosphere Insulin Inhalation Powder, Rapid Acting Analog | Type 1 Diabetes Mellitus | 17 | Sep 2012actual | — | 2013-01-25 |
| Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C InhalerNCT01490762area-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 dosingRandomized · Open-label · Basic science | Phase 1 | Completed | Drug: Technosphere Insulin Inhalation Powder using the Gen2C inhaler, Regular Human Insulin | Healthy | 35 | May 2012actual | — | 2012-09-07 |
| Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With MelanomaNCT01026051To evaluate the objective response, where response is defined as either complete response (CR), partial response (PR), or stable disease (SD) for 12 weeks or longer (CR, PR, and SD are defined according to RECIST 1.1 criteria)Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Financial/Business Reasons | Biological: MKC1106-MT | Stage III Melanoma, Stage IV Melanoma | 5 | Sep 2011actual | — | 2012-05-15 |
| Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 InhalerNCT01196104results2014-10-21Change in HbA1c (%) From Baseline to Week 16Randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: For Business Reasons | Drug: Technosphere® Insulin Inhalation Powder, Insulin Aspart, Insulin Glargine | Type 2 Diabetes | 39 | Aug 2011actual | — | 2014-10-30 |
| Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166NCT01201928observationalComparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models. | — | Terminatedsponsor's stated reason: Parent trials were either not initiated or terminated | Drug: Comparator administered in parent trial, Technosphere Insulin Inhalation Powder | Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus | 3 | Mar 2011actual | — | 2012-12-06 |
| Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate IntakeNCT00747006results2014-10-21Lunch Plasma Glucose Time 0 Corrected AUC (0-240) - Original Protocol (TI Treated Type 1 Subjects)Randomized · Open-label · Treatment | Phase 2 | Terminatedsponsor's stated reason: Business reasons | Drug: TI Inhalation Powder and Humalog (Amendment 1), TI Inhalation Powder (original protocol) | Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 | 18 | Feb 2011actual | — | 2014-10-30 |
| Pharmacokinetic Study in Healthy VolunteersNCT01365117The relative exposure (Cmax and AUC0-120) of insulin from TI Inhalation Powder as deliveredRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere® Insulin Inhalation Powder, Technosphere® Insulin Inhalation Powder | Healthy Volunteers | 50 | Feb 2011actual | — | 2012-06-14 |
| Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma.NCT00688090Is to assess the safety and tolerability of MKC1106-MT regimenRandomized · Open-label · Treatment | Phase 1 | Completed | Biological: Biological: MKC1106-MT, Biological: MKCC1106-MT | Advanced Melanoma, Stage III and IV Melanoma | 19 | Dec 2009actual | — | 2010-08-03 |
| Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-WeeksNCT00700622results2014-10-16Change From Baseline in HbA1c to Week 16Randomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Sponsor stopped development of the MedTone inhaler in favor of an improved device (Gen2 inhaler) | Drug: Technosphere Insulin, Insulin glargine, Insulin lispro | Diabetes, Type 1 | 130 | Nov 2009actual | — | 2014-10-16 |
| Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer.NCT00423254To determine the immunologic response to the treatment with MKC1106-PP regimen and 2) to determine the safety and adverse event profile of MKC1106-PPRandomized · Open-label · Treatment | Phase 1 | Completed | Biological: PSMA/PRAME, PSMA/PRAME | Ovarian, Melanoma, Renal, Prostate, Colorectal, Endometrial Carcinoma, Cervical Carcinoma, Testicular Cancer, Thyroid Cancer, Small Cell Lung Carcinoma, Mesothelioma, Breast Carcinoma, Esophageal Carcinoma, Gastric Cancer, Pancreatic Carcinoma, Neuroendocrine Cancer, Liver Cancer, Gallbladder Cancer, Biliary Tract Cancer, Anal Carcinoma, Bone Sarcomas, Soft Tissue Sarcomas, Carcinoma of Unknown Origin, Primary | 12 | Sep 2009actual | — | 2010-08-03 |
| A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 DiabetesNCT00570687results2014-10-16Time to Minimum Endogenous Glucose Production (EGP) - Meal ChallengeRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere Insulin | Diabetes Mellitus, Type 2 | 30 | Jan 2009actual | — | 2014-10-16 |
| A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin LisproNCT00662857results2014-10-16Bioequivalence of Two 15 U Cartridges (TI Inhalation Powder A) and One 30 U Cartridge (TI Inhalation Powder B) Based on Baseline Corrected Insulin AUC0-360Randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder, RAA Population | Diabetes Mellitus: Type 1 | 29 | Nov 2008actual | — | 2014-10-16 |
| A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmaticsNCT00673621AUCF 0-360 min of serum insulinNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere Insulin Inhalation Powder, Salbutamol (Albuterol), Methacholine chloride | Asthma, Diabetes Mellitus | 30 | Nov 2008actual | — | 2012-06-13 |
| A Trial to Determine How Long Insulin and FDKP (the Molecule That Forms Technosphere Particles) Stays in the Lungs of Healthy Individuals After Inhalation of Technosphere® Insulin (TI) Powder Using Bronchoalveolar Lavage (BAL)NCT00757367Estimation of the amount of insulin in the lungs and amount of FDKP by analyzing BAL fluid, obtained by a flexible fiber optic bronchoscope at various time points after admin of TI Inhalation Powder.Randomized · Open-label · Treatment | Phase 1 | Completed | Drug: TI Inhalation Powder | Healthy Subjects | 13 | Oct 2008actual | — | 2013-12-17 |
| Safety of Inhaled Insulin With Type 1 and Type 2 DiabetesNCT00308737results2014-10-16Change From Baseline to Month 24 in Forced Expiratory Volume in 1 Second (FEV1) by MMRM for TI vs Usual CareRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Technosphere® Insulin Inhalation Powder, Usual Care | Diabetes, Type 1, Diabetes, Type 2 | 2,053 | Sep 2008actual | — | 2014-10-16 |
| Single Dose, Single Administration Study of Technosphere Inhalation Powder in Diabetic Subjects With Mild or Moderate Kidney Disease Compared to Diabetic Subjects With Normal Kidney FunctionNCT00626249Differences in exposure to fumaryl diketopiperazine (FDKP)Non-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere Inhalation Powder | Mild Nephropathy, Moderate Nephropathy, Diabetes Mellitus | 36 | Sep 2008actual | — | 2013-12-17 |
| A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes MellitusNCT00642538AUC 0-240 min post-prandial serum glucoseRandomized · Double-masked · Treatment | Phase 1 | Completed | Drug: MKC253 Inhalation Powder, Technosphere Inhalation Powder, subcutaneous injection | Diabetes Mellitus, Type 2 | 20 | Sep 2008actual | — | 2012-06-14 |
| A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy VolunteersNCT00674050PK parameters of serum insulinNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere Insulin (TI) Inhalation Powder, Albuterol (Salbutamol), Fluticasone | Diabetes Mellitus, Healthy Subjects | 13 | Sep 2008actual | — | 2012-06-13 |
| A 2-Month Safety Follow-Up TrialNCT00741429observationalChange in FEV1 (L) from Baseline Visit in Parent Trial to Visit 2 of MKC-TI-126 | — | Completed | Drug: Technosphere Insulin Inhalation Powder, Comparator | Type 1 Diabetes, Type 2 Diabetes | 649 | Sep 2008actual | — | 2014-12-03 |
| 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-upNCT00309244results2014-10-16Change From Baseline in HbA1c to Week 52Randomized · Open-label · Prevention | Phase 3 | Completed | Drug: Technosphere® Insulin Inhalation Powder, 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) | Diabetes Type 2 | 677 | Aug 2008actual | — | 2014-10-16 |
| A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration.NCT00721344The primary endpoint is the time-matched, placebo-subtracted change from baseline in QTc after a supratherapeutic dose of Technosphere Inhalation PowderRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: Technosphere Inhalation Powder (FDKP), Moxifloxacin, Technosphere Inhalation Powder (FDKP), Placebo | Healthy Subjects | 48 | Aug 2008actual | — | 2012-06-13 |
| A Study to Evaluate Insulin in the Blood After Inhalation of a Dry Powder Insulin Formulation (Called Technosphere®/Insulin) in Non-diabetic Patients With & Without Chronic Obstructive Pulmonary Disease (COPD)NCT01021891To 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 FDKPNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere®/Insulin | Chronic Obstructive Pulmonary Disease (COPD) | 39 | Aug 2008actual | — | 2013-12-17 |
| Efficacy & Safety of Inhaled Insulin in Type 1 DiabetesNCT00308308results2014-10-16Compare the Mean Change From Baseline to Week 52 in HbA1cRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Technosphere Insulin, Active comparator | Diabetes, Type I | 589 | Jul 2008actual | — | 2014-10-16 |
| Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal ChallengeNCT00642681observationalTo measure Serum FDKP AUC | — | Completed | Drug: Technosphere Insulin | Diabetes Mellitus, Upper Respiratory Infection | 20 | Jul 2008actual | — | 2014-12-03 |
| An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' TrialNCT00754624results2014-10-16Annual Rate of Change in FEV1 From Baseline to End of StudyNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler | Type 2 Diabetes Mellitus | 229 | Jun 2008actual | — | 2014-10-16 |
| 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 DiabetesNCT00332488results2014-10-16Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+SecretagogueRandomized · Open-label · Treatment | Phase 3 | Completed | Drug: Technosphere Insulin, Metformin & Secretagogues, Technosphere Insulin & Metformin | Diabetes Mellitus, Type 2 | 547 | Mar 2008actual | — | 2014-10-16 |
| Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and AsthmaNCT00332826The primary safety outcome will be measurements of post bronchodilator FEV1 throughout the treatment periodRandomized · Open-label · Treatment | Phase 3 | Terminatedsponsor's stated reason: Non-safety related business decision to combine special population protocols | Drug: Technosphere Insulin | Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Asthma | 3 | Oct 2007actual | — | 2012-05-04 |
| A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult MalesNCT00475371Determine the safety and tolerability of ascending doses of MKC253 Inhalation PowderNon-randomized · Open-label · Treatment | Phase 1 | Completed | Drug: MKC253 Inhalation Powder | Diabetes Mellitus, Type 2, Healthy Males | 26 | Jun 2007actual | — | 2012-06-14 |
| Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 DiabetesNCT00934414To 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 bioavailabilityNon-randomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere Insulin Inhalation Powder | Diabetes Type 2 | 24 | Aug 2006actual | — | 2009-07-08 |
| 18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 DiabetesNCT00511732HbA1c change from baseline (week 6) to end of treatment (week 17)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Technosphere Insulin, Technosphere Placebo | Type 2 Diabetes Mellitus | 227 | Aug 2005actual | — | 2012-04-30 |
| Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 DiabetesNCT00511602HbA1c change from baseline (week 2) to end of treatment (week 12)Randomized · Double-masked · Treatment | Phase 2 | Completed | Drug: Technosphere Insulin, Technosphere Placebo | Type 2 Diabetes Mellitus | 123 | Nov 2004actual | — | 2012-04-30 |
| Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 DiabetesNCT00511719Dose-corrected area-under-the serum insulin concentration vs. time curve (AUC0-540 min) for inhaled Technosphere® Insulin compared to that of subcutaneous regular human insulinRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere Insulin, Actrapid | Type 2 Diabetes Mellitus | 13 | Apr 2004actual | — | 2011-06-29 |
| Vaccine Therapy in Treating Patients With Stage IV MelanomaNCT00033228The primary objective of the study was to evaluate the safety and tolerability of Synchrovax® pSEM Vaccine measured by the adverse event and severe adverse event profile.Open-label · Treatment | Phase 1/2 | Completed | Biological: MKC1106-MT, MKC1106-MT, MKC1106-MT | Melanoma (Skin) | 19 | Mar 2003actual | — | 2011-05-12 |
| Vaccine Therapy in Treating Patients With Stage IV MelanomaNCT00023647Frequency of adverse events assessed by complete blood count, blood chemistry, polymerase chain reaction, physical examination and urinalysisOpen-label · Treatment | Phase 1 | Completed | Biological: Synchrotope TA2M, Synchrotope TA2M, Synchrotope TA2M | Melanoma (Skin) | 26 | Apr 2002actual | — | 2012-07-10 |
| Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human InsulinNCT00511979Dose-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 treatmentRandomized · Open-label · Treatment | Phase 1 | Completed | Drug: Technosphere Insulin, Technosphere insulin, Technosphere insulin, Regular human insulin | Healthy | 12 | Feb 2000actual | — | 2012-06-26 |
| To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus.NCT00419302Glycemic response to a meal challengeRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere/Insulin | Diabetes Mellitus, Type 2 | 16 | — | — | 2009-10-14 |
| A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin GlargineNCT00539396Change in blood glucose following a standard mealRandomized · Open-label · Treatment | Phase 2 | Completed | Drug: Technosphere Insulin | Diabetes Mellitus, Type 1 | 110 | — | — | 2009-10-14 |
| Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes MellitusNCT00539890Mean change in HbA1c from baseline to treatment week 24Randomized · Open-label · Treatment | Phase 3 | Completed | Drug: Technosphere Insulin | Diabetes Type 2 | 0 | — | — | 2009-10-14 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19