Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Inhaled Technosphere Insulin
Technosphere Insulin · 21 trials · 19 indications
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)
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 |
|---|---|---|
| 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 |
| Afrezza (Technosphere Insulin) + Basal Insulin | EXPERIMENTAL | Individualized dose of Afrezza (Technosphere Insulin) and basal insulin for each patient before each meal (breakfast, lunch, and dinner) for 13 weeks. |
| 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 |
| 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 |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Technosphere insulin inhalation system, 25 units | EXPERIMENTAL | - |
| Technosphere insulin inhalation system, 50 units | EXPERIMENTAL | - |
| Technosphere insulin inhalation system, 100 units | EXPERIMENTAL | - |
| Subcutaneous regular human insulin | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| 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 |
| Basal insulin | DRUG | subcutaneously-injected basal insulin |
| 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 |
| 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% |
| Regular human insulin | DRUG | - |
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...
Technosphere Insulin is an investigational inhaled insulin being studied for the treatment of diabetes mellitus, including Type 1 and Type 2 diabetes. It is also being evaluated in clinical trials for use in asthma and in healthy volunteers. The drug is delivered via inhalation as a powder formulation.
Technosphere Insulin is being developed by MannKind Corporation, a biopharmaceutical company listed on the NASDAQ under the ticker symbol MNKD. The company is conducting clinical trials to evaluate the safety and efficacy of this inhaled insulin product across multiple patient populations.
Technosphere Insulin is in Phase 1 clinical development. While some completed trials have been in Phase 2 and Phase 3, the most recent trial listed is Phase 2, and the overall development program includes studies across multiple phases. The drug remains investigational and has not been approved by regulatory authorities.
Technosphere Insulin has been studied in several clinical trials. NCT00511719 evaluated its bioavailability in Type 2 diabetes. NCT01445951 compared it to insulin aspart in Type 1 diabetes over 24 weeks. NCT01544881 compared it to a rapid-acting analog in Type 1 diabetes. NCT07224321 is an ongoing Phase 2 trial in youth with newly-diagnosed Type 1 diabetes.
Yes, Technosphere Insulin is also known as Inhaled Technosphere Insulin. The drug is sometimes referred to by this alternative name in clinical and research contexts. Both names refer to the same investigational inhaled insulin product being developed by MannKind Corporation.
Technosphere Insulin is a small molecule designed for inhalation. It uses Technosphere technology to deliver insulin directly to the lungs, where it is absorbed into the bloodstream. This approach aims to provide rapid-acting insulin delivery for glycemic control in patients with diabetes.