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

A Phase 2 Randomized, Open Label, Multi-Center Study of the Use of Prandial Inhaled Technosphere Insulin in Combination With Basal Subcutaneous Lantus as Basal Insulin Versus Prandial Subcutaneous NovoRapid in Combination With Basal Subcutaneous Lantus Insulin in Subjects With Type 1 Diabetes Mellitus

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00539396

Enrollment

110

Registered

2007-10-04

Start date

2005-03-31

Completion date

2005-12-31

Last updated

2009-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Brief summary

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

Interventions

DRUGTechnosphere Insulin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months * BMI \<40 kg/m squared * HbA1c greater than or equal to 7% and less than or equal to 11.5% * Serum creatinine less than 2 for males and less than 1.8 for females * Acceptable pulmonary function

Exclusion criteria

* Significant hepatic disease * Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes

Design outcomes

Primary

Measure	Time frame
Change in blood glucose following a standard meal	0-300 minutes

Secondary

Measure	Time frame
Mean change from baseline HbA1c	week 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026