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

PHASE4CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 30, 2017

Primary Completion Date

December 15, 2017

Study Completion Date

January 31, 2018

Conditions
Diabetes Mellitus, Type 1
Interventions
DRUG

Technosphere insulin

This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.

Trial Locations (1)

80045

Barbara Davis Center, Aurora

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Atlanta Diabetes Associates

OTHER

collaborator

University of Southern California

OTHER

collaborator

Rainier Clinical Research Center

OTHER

collaborator

Mannkind Corporation

INDUSTRY

lead

University of Colorado, Denver

OTHER