MannKind Corp
MNKDHealthcare|Biotechnology|USA
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Clinical Trials (64)
| Trial | Conditions | Phase | Status | Enrollment | Design | Drug |
|---|---|---|---|---|---|---|
| NCT06535789 Inhaled Insulin vs Rapid-acting Injections for Post-meal Glucose Control in Women With Gestational Diabetes | Diabetes, Gestational, Pregnancy Complications | P2P3 | Recruiting | 30 | RCT, Open-label | Inhaled Technosphere Insulin |
| NCT07679893 Phase 2 Clinical Trial of MNKD-201 (Nintedanib Dry Powder Inhalation) in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis (IPF) | P2 | Recruiting | 210 | RCT, Double-blind | Nintedanib Dry Powder Inhalation, Placebo |
| NCT07224321 INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes | Type 1 Diabetes Mellitus | P2 | Recruiting | 100 | Open-label | Technosphere Insulin, Technosphere Insulin, Basal insulin |
| NCT07344558 A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis | Idiopathic Pulmonary Fibrosis (IPF) | P1 | Recruiting | 24 | RCT, Double-blind | MNKD-201(Nintedanib DPI), Placebo |
| NCT06532942 A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers | Healthy Volunteers | P1 | Recruiting | 40 | RCT, Double-blind | (Part A) MKND-201, Placebo, (Part B) MKND-201 |
| NCT06880835 Effect of Inhaled Technosphere Insulin vs RAA Insulin on Exercise-Induced Hypoglycemia in Adults With T1D Using Automated Insulin Delivery | Diabetes Mellitus, Type 1 | N/A | Recruiting | 30 | RCT, Open-label | — |
| NCT04125082 A Study to Evaluate Time in Range in Type 2 Diabetics Using Afrezza® Plus Basal Insulin Compared to Multiple Daily Injections | Type 2 Diabetes Treated With Insulin | P4 | Unknown | 29 | Open-label | Afrezza Inhalant Product |
| NCT03143816 Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study | Diabetes Mellitus, Type 1 | P4 | Completed | 60 | RCT, Open-label | Technosphere insulin |
| NCT05243628 Afrezza With Basal Combination (ABC): Afrezza® Combined With AID Pump or Insulin Degludec in Adults With Type 1 Diabetes | Type 1 Diabetes | P4 | Completed | 33 | RCT, Open-label | Afrezza (insulin human) Inhalation Powder, insulin degludec |
| NCT05904743 INHALE-3: Afrezza® Combined With Insulin Degludec Versus Usual Care in Adults With Type 1 Diabetes | Diabetes Mellitus, Type 1 | P4 | Completed | 141 | RCT, Open-label | Afrezza, insulin degludec, Rapid-acting Insulin Analog, Basal Insulin |
| NCT04849845 Afrezza® Dosing Optimization Study | Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 | P4 | Completed | 20 | Open-label | — |
| NCT03313960 A Randomized Controlled Trial Evaluating One Drop | Premium With Afrezza vs. One Drop | Premium Alone | Diabetes Mellitus, Type 2 | P4 | Unknown | 400 | RCT, Open-label | Afrezza plus One Drop | Premium |
| NCT00332826 Inhaled Technosphere Insulin in Subjects With Diabetes Mellitus and Asthma | Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 | P3 | Terminated | 3 | RCT, Open-label | Technosphere Insulin |
| NCT01451398 Comparison of Technosphere® Insulin Versus Technosphere Powder (Placebo) in Insulin-Naive Subjects With Type 2 Diabetes Mellitus | Type 2 Diabetes | P3 | Completed | 353 | RCT, Double-blind | Technosphere® Insulin, Technosphere Powder |
| NCT00308737 Safety of Inhaled Insulin With Type 1 and Type 2 Diabetes | Diabetes, Type 1, Diabetes, Type 2 | P3 | Completed | 2,053 | RCT, Open-label | Technosphere® Insulin Inhalation Powder, Usual Care |
| NCT01196104 Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Inhalation Insulin (TI) Inhalation Powder Using the Gen2 Inhaler | Type 2 Diabetes | P3 | Terminated | 39 | RCT, Open-label | Technosphere® Insulin Inhalation Powder, Insulin Aspart, Insulin Glargine |
| NCT00539890 Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus | Diabetes Type 2 | P3 | Completed | — | RCT, Open-label | Technosphere Insulin |
| NCT00642616 Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease | Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus | P3 | Terminated | 34 | RCT, Open-label | Technosphere® Insulin, Usual Care |
| NCT06418711 ICoN-1 Phase 3 Study of the Efficacy and Safety of Treatment With MNKD-101, Clofazimine Inhalation Suspension | MAC Lung Disease, Treatment Refractory MAC Lung Disease | P3 | Terminated | 132 | RCT, Double-blind | Clofazimine Inhalation Suspension, Placebo |
| NCT00332488 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 | P3 | Completed | 547 | RCT, Open-label | Technosphere Insulin, Metformin & Secretagogues, Technosphere Insulin & Metformin |
| NCT01445951 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 | P3 | Completed | 518 | RCT, Open-label | Technosphere® Insulin with MedTone C Inhaler, Technosphere ®Insulin with Gen2 Inhaler, Insulin Aspart in combination with a basal insulin |
| NCT00308308 Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes | Diabetes, Type I | P3 | Completed | 589 | RCT, Open-label | Technosphere Insulin, Active comparator |
| NCT04974528 Afrezza® INHALE-1 Study in Pediatrics | Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2 | P3 | Completed | 319 | RCT, Open-label | Afrezza, Rapid-acting Insulin Analog, Basal Insulin |
| NCT00309244 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 | P3 | Completed | 677 | RCT, Open-label | Technosphere® Insulin Inhalation Powder, 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) |
| NCT03324776 Initiating Mealtime Ultra-Rapid Acting Insulin (Afrezza) in Uncontrolled Type 2 Diabetes Patients | Type2 Diabetes | P3 | Completed | 20 | Open-label | Afrezza Inhalant Product |
| NCT00700622 Safety and Efficacy of Technosphere® Insulin Inhalation Powder and Lantus® Compared to Humalog® and Lantus® Over 16-Weeks | Diabetes, Type 1 | P3 | Terminated | 130 | RCT, Open-label | Technosphere Insulin, Insulin glargine, Insulin lispro |
| NCT00662857 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 Lispro | Diabetes Mellitus: Type 1 | P2 | Completed | 29 | RCT, Open-label | Technosphere® Insulin Inhalation Powder, Technosphere Insulin® Inhalation Powder, RAA Population |
| NCT00033228 Vaccine Therapy in Treating Patients With Stage IV Melanoma | Melanoma (Skin) | P1P2 | Completed | 19 | Open-label | MKC1106-MT, MKC1106-MT, MKC1106-MT |
| NCT00934414 Clamp Study Comparing Inhalation of Technosphere®/Insulin in Smokers and Non-Smokers With Type 2 Diabetes | Diabetes Type 2 | P2 | Completed | 24 | Open-label | Technosphere Insulin Inhalation Powder |
| NCT00754624 An Open-label, Multi-center, International, Three-year, Safety and Tolerability 'Follow on' Trial | Type 2 Diabetes Mellitus | P2 | Completed | 229 | Open-label | Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler |
| NCT00570687 A Study Comparing Subcutaneous Rapid Acting Insulin and One Formulation of Inhaled Insulin in Subjects With Type 2 Diabetes | Diabetes Mellitus, Type 2 | P2 | Completed | 30 | RCT, Open-label | Technosphere Insulin |
| NCT00511719 Bioavailability of Technosphere® Insulin Versus Subcutaneous Regular Human Insulin in Type 2 Diabetes | Type 2 Diabetes Mellitus | P2 | Completed | 13 | RCT, Open-label | Technosphere Insulin, Actrapid |
| NCT00539396 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 Glargine | Diabetes Mellitus, Type 1 | P2 | Completed | 110 | RCT, Open-label | Technosphere Insulin |
| NCT01026051 Safety, Immune and Tumor Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma | Stage III Melanoma, Stage IV Melanoma | P2 | Terminated | 5 | Open-label | MKC1106-MT |
| NCT00747006 Safety and Efficacy of Technosphere® Insulin Inhalation Powder (TI Inhalation Powder)When an Optimal Dose is Taken With Varied Carbohydrate Intake | Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1 | P2 | Terminated | 18 | RCT, Open-label | TI Inhalation Powder and Humalog (Amendment 1), TI Inhalation Powder (original protocol) |
| NCT00511732 18-Week, Randomized, Double-blind, Placebo Controlled, Forced Titration Study of Patients With Type 2 Diabetes | Type 2 Diabetes Mellitus | P2 | Completed | 227 | RCT, Double-blind | Technosphere Insulin, Technosphere Placebo |
| NCT00419302 To Compare the Effect of Inhaled Insulin With Subcutaneously Injected Insulin in Subjects With Type 2 Diabetes Mellitus. | Diabetes Mellitus, Type 2 | P2 | Completed | 16 | RCT, Open-label | Technosphere/Insulin |
| NCT00511602 Study of the Efficacy and Safety of Inhaled Technosphere Insulin in Patients With Type 2 Diabetes | Type 2 Diabetes Mellitus | P2 | Completed | 123 | RCT, Double-blind | Technosphere Insulin, Technosphere Placebo |
| NCT02527265 Afrezza Safety and Pharmacokinetics Study in Pediatric Patients | Type 1 Diabetes Mellitus | P2 | Completed | 30 | Open-label | Afrezza |
| NCT00757367 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) | Healthy Subjects | P1 | Completed | 13 | RCT, Open-label | TI Inhalation Powder |
| NCT00626249 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 Function | Mild Nephropathy, Moderate Nephropathy | P1 | Completed | 36 | Open-label | Technosphere Inhalation Powder |
| NCT00688090 Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma. | Advanced Melanoma, Stage III and IV Melanoma | P1 | Completed | 19 | RCT, Open-label | Biological: MKC1106-MT, Biological: MKCC1106-MT |
| NCT03464864 Pharmacokinetics, Safety and Tolerability of Treprostinil Inhalation Powder in Healthy Normal Volunteers | Pulmonary Arterial Hypertension | P1 | Completed | 36 | Open-label | Treprostinil Inhalation Powder |
| NCT01544881 Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes | Type 1 Diabetes Mellitus | P1 | Completed | 17 | RCT, Open-label | Technosphere Insulin Inhalation Powder, Rapid Acting Analog |
| NCT00642538 A Study Designed to Determine the Safety and Pharmacological Response ofMKC253 Inhalation Powder in Adults With Type 2 Diabetes Mellitus | Diabetes Mellitus, Type 2 | P1 | Completed | 20 | RCT, Double-blind | MKC253 Inhalation Powder, Technosphere Inhalation Powder, subcutaneous injection |
| NCT00673621 A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics | Asthma, Diabetes Mellitus | P1 | Completed | 30 | Open-label | Technosphere Insulin Inhalation Powder, Salbutamol (Albuterol), Methacholine chloride |
| NCT00511979 Comparison of the Effect on the Glucose Infusion Rates Between Inhaled Technosphere Insulin and a Subcutaneous Injection of Regular Human Insulin | Healthy | P1 | Completed | 12 | RCT, Open-label | Technosphere Insulin, Technosphere insulin, Technosphere insulin, Regular human insulin |
| NCT01365117 Pharmacokinetic Study in Healthy Volunteers | Healthy Volunteers | P1 | Completed | 50 | RCT, Open-label | Technosphere® Insulin Inhalation Powder, Technosphere® Insulin Inhalation Powder |
| NCT00475371 A First in Human, Single Dose, Safety and Tolerability Study of MKC253 Inhalation Powder in Healthy Adult Males | Diabetes Mellitus, Type 2, Healthy Males | P1 | Completed | 26 | Open-label | MKC253 Inhalation Powder |
| NCT01902121 Compare the Same Dosage of Insulin Using a Combination of Cartridges, 30 Units as 2 Cartridges vs. 1 Cartridge | Healthy Volunteers | P1 | Completed | 40 | RCT, Open-label | Technosphere® Insulin 10U + 20U, Technosphere® Insulin 30U |
| NCT00023647 Vaccine Therapy in Treating Patients With Stage IV Melanoma | Melanoma (Skin) | P1 | Completed | 26 | Open-label | Synchrotope TA2M, Synchrotope TA2M, Synchrotope TA2M |
| NCT00674050 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 Volunteers | Diabetes Mellitus, Healthy Subjects | P1 | Completed | 13 | Open-label | Technosphere Insulin (TI) Inhalation Powder, Albuterol (Salbutamol), Fluticasone |
| NCT00423254 Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-PP) for Patients With Advanced Cancer. | Ovarian, Melanoma | P1 | Completed | 12 | RCT, Open-label | PSMA/PRAME, PSMA/PRAME |
| NCT02485327 PK and PD Within-Subject Variability of a Single Dose of Afrezza Inhaled Technosphere Insulin in Patients With Diabetes Mellitus Type 1 (T1DM) | Type 1 Diabetes Mellitus | P1 | Completed | 22 | Open-label | Technosphere Insulin SAR439065 Afrezza® |
| NCT00721344 A Study to Determine if Technosphere® Inhalation Powder (FDKP) Causes ECG Changes (QTc) Following the Medication's Inhaled Administration. | Healthy Subjects | P1 | Completed | 48 | RCT, Double-blind | Technosphere Inhalation Powder (FDKP), Moxifloxacin, Technosphere Inhalation Powder (FDKP), Placebo |
| NCT01490762 Healthy Normal Volunteers Looking at Exposure and Effects of Multiple Doses of Technosphere® Insulin (TI) Using the Gen2C Inhaler | Healthy | P1 | Completed | 35 | RCT, Open-label | Technosphere Insulin Inhalation Powder using the Gen2C inhaler, Regular Human Insulin |
| NCT02470637 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 Mellitus | Type 1 Diabetes Mellitus | P1 | Completed | 30 | RCT, Open-label | SAR439065, Insulin lispro |
| NCT01982604 Comparison of 30 Units of TI (Technosphere® Insulin) Prepared With Insulin From Two Different Suppliers | Healthy Volunteers | P1 | Completed | 38 | RCT, Open-label | TI-Inhalation Powder A, TI-Inhalation Powder B |
| NCT01021891 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) | Chronic Obstructive Pulmonary Disease (COPD) | P1 | Completed | 39 | Open-label | Technosphere®/Insulin |
| NCT01459133 Single Site, Single Subject, Treatment IND With Mannkind Corporation's Technosphere Inhalation System | Diabetes | N/A | Withdrawn | — | Open-label | Technosphere® Insulin Inhalation System |
| NCT01798914 Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder | Type 1 Diabetes, Type 2 Diabetes | NO_LONGER_AVAILABLE | — | — | Technosphere Insulin Inhalation Powder | |
| NCT01201928 Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166 | Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus | Terminated | 3 | — | Comparator administered in parent trial, Technosphere Insulin Inhalation Powder | |
| NCT00642681 Effects of URI on Diabetic Subjects Utilizing Technosphere Insulin After a Meal Challenge | Diabetes Mellitus, Upper Respiratory Infection | Completed | 20 | — | Technosphere Insulin | |
| NCT00741429 A 2-Month Safety Follow-Up Trial | Type 1 Diabetes, Type 2 Diabetes | Completed | 649 | — | Technosphere Insulin Inhalation Powder, Comparator |