Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication AFREZZA ® is indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. AFREZZA ® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult and pediatric patients 6 years of age and older with diabetes mellitus. FDA label
Also known as Technosphere Insulin Inhalation Powder, Technosphere Insulin (TI) Inhalation Powder, Inhaled Technosphere Insulin, Afrezza, Afrezza (insulin human) Inhalation Powder
Technosphere Insulin · 22 trials · 17 indications
Change in HbA1c from baseline to Week 26, for noninferiority assessment
Efficacy as measured by change in glycated hemoglobin (HbA1c) at Week 24
Change from Baseline to End of Study in FEV1 by MMRM
FEV1 decrease of ≥ 15% from Baseline value at last measurement
Percentage of participants with a CGM-measured TIR 70-180 mg/dL ≥70% during 14 days prior to 13-week visit
3-hour post-prandial (PP) area under the curve \>120 mg/dL (AUC120)
Insulin Cmax after a dose of Afrezza
Dose-normalized baseline-corrected area under the serum insulin vs. time curve
Maximum observed baseline-corrected serum insulin concentration
Dose-normalized baseline-corrected area under the serum insulin vs. time curve (time 0 to 360 minutes post-dose)
Time to minimum EGP post dose
Minimum calculated EGP per subject as change from baseline
EGP area over the curve from 0 to 480 minutes postdose
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after TI administration
Timepoints: 0 minutes (before meal) and at 15, 30, 60, 90, 120, 180, 240, and 300 minutes after Technosphere Placebo administration
| Arm | Type | Description |
|---|---|---|
| Afrezza (Technosphere Insulin) + Basal Insulin | EXPERIMENTAL | Individualized dose of Afrezza (Technosphere Insulin) for each patient before each meal (breakfast, lunch, and dinner) for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient. |
| RAA Injection + Basal Insulin | ACTIVE_COMPARATOR | Individualized dose of RAA injection (insulin aspart, insulin lispro or insulin glulisine) for each patient for 26 weeks. Individualized basal insulin (insulin degludec, insulin glargine or insulin detemir) for each patient. |
| TI inhalation powder | EXPERIMENTAL | Technosphere® Insulin powder administered via the Gen2 inhaler added to 2 or more stable OADs |
| Technosphere powder | PLACEBO_COMPARATOR | Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable OADs |
| Technosphere® Insulin with MedTone C Inhaler | EXPERIMENTAL | Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry |
| Aspart Group | ACTIVE_COMPARATOR | Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry |
| Technosphere ® Insulin-Gen2 Group | EXPERIMENTAL | Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry |
| 1 | EXPERIMENTAL | Technosphere Insulin |
| 2 | ACTIVE_COMPARATOR | Rapid-acting analogue insulin plus basal insulin glargine |
| TI + Insulin glargine | EXPERIMENTAL | Technosphere® Insulin Inhalation Powder + insulin glargine |
| BPR 70/30 | ACTIVE_COMPARATOR | 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) |
| Usual care | OTHER | Usual care |
| Non-diabetes | NO_INTERVENTION | Subjects without abnormalities in glucose control (Note: Hypoglycemia and HbA1c were not reported for this group) |
| 3 | EXPERIMENTAL | Technosphere \& Metformin |
| technosphere insulin (TI) | EXPERIMENTAL | All participants will ingest one standardized meal using technosphere insulin to manage their blood glucose |
| Rapid-acting insulin analog | NO_INTERVENTION | All participants will ingest one standardized meal using their prescribed rapid-acting insulin analog (RAA) to manage their blood glucose |
| Afrezza (Technosphere Insulin) | EXPERIMENTAL | Individualized dose of Afrezza (Technosphere Insulin) for each patient at each meal (breakfast, lunch, and dinner) for 30 days. During the trial, all patients will receive multiple injections of basal long acting insulin, in general at bedtime every day. |
| 1: TI Inhalation Powder A | EXPERIMENTAL | Technosphere® Insulin Inhalation Powder, two 15 U cartridges |
| 2: TI Inhalation Powder B | EXPERIMENTAL | Technosphere® Insulin Inhalation Powder, one 30 U cartridge |
| 3: RAA Population | EXPERIMENTAL | Rapid Acting Analogue subjects received 10 IU sc Insulin Lispro |
| Smokers | EXPERIMENTAL | - |
| Non-Smokers | EXPERIMENTAL | - |
| Technosphere Insulin | EXPERIMENTAL | - |
| Technosphere Inhalation Powder | PLACEBO_COMPARATOR | - |
| Actrapid | ACTIVE_COMPARATOR | Subcutaneous regular human insulin |
| Technosphere Insulin Inhalation Powder | EXPERIMENTAL | - |
| RAA | ACTIVE_COMPARATOR | Rapid Acting Analog |
| Name | Type | Description |
|---|---|---|
| Afrezza | BIOLOGICAL | Pharmaceutical form: powder Route of administration: inhalation |
| Rapid-acting Insulin Analog | BIOLOGICAL | Pharmaceutical form: clear and colorless solution for injection Route of administration: subcutaneous |
| Basal Insulin | BIOLOGICAL | Pharmaceutical form: solution for injection Route of administration: subcutaneous |
| Technosphere® Insulin | DRUG | Technosphere® Insulin Inhalation Powder |
| Technosphere Powder | DRUG | Placebo Comparator |
| Technosphere® Insulin with MedTone C Inhaler | DRUG | Inhalation Powder and injectable insulin |
| Technosphere ®Insulin with Gen2 Inhaler | DRUG | Inhalation Powder and injectable insulin |
| Insulin Aspart in combination with a basal insulin | DRUG | Injectable insulin |
| Technosphere Insulin | DRUG | Inhalation, 15U/30U |
| Active comparator | DRUG | sc injectable insulin |
| Technosphere® Insulin Inhalation Powder | DRUG | Inhalation, 15U/30U |
| 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin) | DRUG | BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc |
| Usual Care | DRUG | Subjects will receive antidiabetes treatment at the discretion of their physicians |
| Metformin & Secretagogues | DRUG | Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations. |
| Technosphere Insulin & Metformin | DRUG | Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets |
| Inhaled Technosphere Insulin | DRUG | Patients will receive TI (Afrezza) to be compared to RAA following a breakfast meal |
| Technosphere Insulin® Inhalation Powder | DRUG | TI Inhalation Powder, one 30 U cartridge |
| RAA Population | DRUG | RAA Population: All subjects received a single 10 IU sc injection of insulin lispro. |
| Technosphere Insulin Inhalation Powder | DRUG | 30U |
| Technosphere Placebo | DRUG | Technosphere Inhalation Powder |
| Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler | DRUG | Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U |
| Actrapid | DRUG | 24IU |
| Rapid Acting Analog | DRUG | Subcutaneous Injection |
| Technosphere Insulin (TI) Inhalation Powder | DRUG | 3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin. |
| Albuterol (Salbutamol) | DRUG | 2 puff= 200ug total dose |
| Fluticasone | DRUG | 2 puffs= 500ug total dose |
| Salbutamol (Albuterol) | DRUG | 2 puff = 200 mcg total dose |
| Methacholine chloride | DRUG | 5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9% |
Inclusion Criteria: * Assent from the pediatric subject, as appropriate, and fully informed consent from the parent(s) or legal guardian, as required by both state and federal laws and the local Institutional Review Board (IRB) * Subjects ≥4 and \<18 years of age * Clinical diagnosis of type 1 diab...
Technosphere Insulin is an inhaled insulin product developed by MannKind Corporation for diabetes. It is delivered as an inhalation powder rather than by injection, and it is being studied across type 1 diabetes, type 2 diabetes, and gestational diabetes. It is an investigational formulation in clinical development.
Technosphere Insulin is being developed to treat diabetes, including type 1 diabetes, type 2 diabetes, and gestational diabetes. Clinical trials have evaluated it for post-meal glucose control and as an alternative to subcutaneous rapid-acting insulin injections. It is not approved for these uses based on the development stage described.
Technosphere Insulin targets insulin, abbreviated INS. Insulin is the hormone that regulates blood glucose, and delivering it by inhalation is intended to provide insulin action after meals. The active ingredient is insulin itself, formulated as an inhalation powder.
Technosphere Insulin is developed by MannKind Corporation, which trades under the ticker MNKD. MannKind is the sponsor of the clinical trials evaluating the inhaled insulin formulation across diabetes indications.
Technosphere Insulin is in Phase 1 development according to its current development stage, and it is investigational rather than approved. Its clinical program spans Phase 1 through Phase 3 studies, with six completed trials and one currently recruiting trial.
Technosphere Insulin has been studied in trials including NCT01544881 in type 1 diabetes, NCT01451398 in insulin-naive type 2 diabetes, NCT06535789 in gestational diabetes, and the recruiting INHALE-1st study NCT07224321 in youth with newly diagnosed type 1 diabetes. Total enrollment across its trials is about 2,053 participants.
Technosphere Insulin is also known as Technosphere Insulin Inhalation Powder and Inhaled Technosphere Insulin, and it has been studied under names referencing the MedTone inhaler, including Technosphere Insulin with MedTone C Inhaler. Afrezza is the brand name associated with MannKind's inhaled insulin, and the INHALE-1st trial is titled with Afrezza.