| Trial ID: | L5047 |
| Source ID: | NCT01798264
|
| Associated Drug: |
Itca 650 (Exenatide In Duros)
|
| Title: |
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01798264/results
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: ITCA 650 (exenatide in DUROS)
|
| Outcome Measures: |
Primary: Number of Subjects With Study Drug-Related Adverse Events, 4 weeks | Secondary: To Characterize the Pharmacokinetic Profile of ITCA 650 in Subjects With Type 2 Diabetes Mellitus, Change in HbA1c from baseline, 4 weeks|Change in Fasting Plasma Glucose (FPG) 4 Weeks From Baseline, 4 weeks|Change in Weight From Baseline to 4 Weeks, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: Intarcia Therapeutics
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-02
|
| Completion Date: |
2009-05
|
| Results First Posted: |
2013-05-17
|
| Last Update Posted: |
2013-05-17
|
| Locations: |
Miami Gardens, Florida, 33169, United States|Medpace Clinical Pharmacology Unit, Cincinnati, Ohio, 45212, United States|dGd Research, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01798264
|
