| Trial ID: | L5053 |
| Source ID: | NCT02059564
|
| Associated Drug: |
Hm11260c
|
| Title: |
A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus
|
| Interventions: |
DRUG: HM11260C|DRUG: Placebo|DRUG: Victoza
|
| Outcome Measures: |
Primary: PK profile of acetaminophen, Cmax, AUC at 13 weeks, 13 weeks | Secondary: Glucose metabolism, Fasting plasma glucose (FPG), Postprandial glucose (PPG), Insulin, C-peptide, HbA1c at 13 weeks, 13 weeks|Safety and tolerability, Incidence and severity of adverse events, findings on physical examination, clinical laboratory abnormalities at 18 weeks, 18 weeks
|
| Sponsor/Collaborators: |
Sponsor: Hanmi Pharmaceutical Company Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
44
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-12
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2014-02-11
|
| Locations: |
Hanmi, California, California, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02059564
|
