A Phase 3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere Insulin Inhalation Powder in Combination With Lantus Versus Humalog in Combination With Lantus in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period
Latest Information Update: 09 Nov 2021
At a glance
- Drugs Insulin (Primary) ; Insulin glargine; Insulin lispro
- Indications Type 1 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors MannKind Corporation
- 25 Sep 2020 Results of a pooled analysis of data pooled from 5 trials (NCT00700622, NCT01445951, NCT00539890, NCT00308308, NCT00309244), assessing the magnitude of weight change of technosphere insulin versus comparators across the pivotal phase three program in type 1 and type 2 diabetes mellitus, presented at the 56th Annual Meeting of the European Association for the Study of Diabetes
- 27 Jul 2020 Results (n=5505) of pooled analysis from 13 clinical studies: MKC-TI-009, MKC-TI-030, MKC-TI-101, MKC-TI-117, MKC-TI-171, MKC-TI-005, MKC-TI-014, MKC-TI-026, MKC-TI-102, MKC-TI-103, PDC-INS-0008, MKC-TI-175 and MKC-TI-162 assessing incidences of respiratory treatment-emergent adverse events, changes in pulmonary function and lung malignancies published in the Clinical Drug Investigation
- 15 Oct 2014 Status changed from completed to discontinued, as reported by the ClinicalTrials.gov record.