Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2544
Source ID: NCT02716610
Associated Drug: Inh 69 U (Low)
Title: Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes
Acronym: Samba-02
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: INH 69 U (low)|DRUG: INH 69 U (high)|DRUG: INH 139 U|DRUG: INH 208 U|DRUG: LIS 18 U
Outcome Measures: Primary: Area under the curve for insulin from 0-8 hours (AUCins0-8h), Assessment of the linearity of the dose-response curves, 0 to 8 hours following each dose|Maximum concentration of insulin (CMaxIns), Assessment of the linearity of the dose-response curves, up to 12 hours following each dose|Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h), Assessment of the linearity of the dose-response curves, 0 to 8 hours following each dose|Maximum glucose infusion rate (GIRmax), Assessment of the linearity of the dose-response curves, up to 12 hours following each dose | Secondary: Bioavailability, Relative delivery efficiency (FREL) of inhaled human insulin (INH) compared to subcutaneous injected insulin lispro (LIS), 0 to 8 hours following each dose
Sponsor/Collaborators: Sponsor: Dance Biopharm Inc.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 24
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
Start Date: 2013-10
Completion Date: 2014-01
Results First Posted:
Last Update Posted: 2016-03-23
Locations:
URL: https://clinicaltrials.gov/show/NCT02716610

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D276 Isoniazid small molecule DB00951 Details
D209 Lisinopril small molecule DB00722 Details