| Trial ID: | L4550 |
| Source ID: | NCT02081118
|
| Associated Drug: |
Hm11260c
|
| Title: |
Glycaemic Control of Monthly 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: Placebo
|
| Outcome Measures: |
Primary: Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks, Up to day 155 | Secondary: Fasting plasma glucose levels (FPG), Up to day 155|7-point glucose profile, Up to day 155|Serum lipid profile, Up to day 155|Body weight, Up to day 155|Fasting insulin, Up to day 155|C-peptide, Up to day 155|Glucagon, Up to day 155|Glycated albumin, Up to day 155 | Other: Number of Participants with Adverse Events by HM11260C, Up to day 155|Number of Participants with Immunogenicity by HM11260C, Up to day 155
|
| Sponsor/Collaborators: |
Sponsor: Hanmi Pharmaceutical Company Limited
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
209
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-02
|
| Completion Date: |
2015-04
|
| Results First Posted: |
|
| Last Update Posted: |
2016-08-09
|
| Locations: |
Hanmi pharmaceutical, Miami, Florida, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02081118
|
