| Trial ID: | L3677 |
| Source ID: | NCT02057172
|
| Associated Drug: |
Hm11260c
|
| Title: |
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: HM11260C|DRUG: liraglutide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks, Up to 127 days | Secondary: Fasting plasma glucose levels (FPG), Up to 127 days|7-point glucose profile, Up to day 127|Other glycaemic control parameters, Up to day 127|Serum lipid profile, Up to day 127|Body weight, Up to day 127|Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7%, Up to 127 days | Other: Assess the safety and tolerability of HM11260C, Up to day 127|Assess the immunogenicity of HM11260C, Up to day 127
|
| Sponsor/Collaborators: |
Sponsor: Hanmi Pharmaceutical Company Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
254
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-01
|
| Completion Date: |
2014-12
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-09
|
| Locations: |
Hanmi pharmaceutical, CA, California, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02057172
|
