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Glucagon-like peptide-1 receptor agonist
Cohort B for Diabetes
Phase 1
Waitlist Available
Led By Hanmi Clinical
Research Sponsored by Hanmi Pharmaceutical Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 weeks
Summary
This trial is testing a new drug, HM11260C, in people with Type 2 Diabetes Mellitus. The study aims to see if this drug can help control blood sugar levels by slowing down how fast food leaves the stomach and improving insulin production. Researchers will also check how safe and acceptable the treatment is. An existing diabetes medication, liraglutide (Victoza), will be used for comparison.
Eligible Conditions
- Diabetes
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PK profile of acetaminophen
Secondary study objectives
Glucose metabolism
Safety and tolerability
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment1 Intervention
The daily treatment with 0.6 mg Victoza will be up titrated to 1.2 mg
Group II: Cohort BExperimental Treatment2 Interventions
The monthly treatment with 4 mg HM11260C or placebo will be up titrated to 16 mg
Group III: Cohort AExperimental Treatment2 Interventions
The weekly treatment of the 6 mg HM11260C or placebo will be maintained
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exenatide
FDA approved
Placebo
1995
Completed Phase 3
~2670
Liraglutide
FDA approved
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Who is running the clinical trial?
Hanmi Pharmaceutical Company LimitedLead Sponsor
194 Previous Clinical Trials
61,815 Total Patients Enrolled
Hanmi ClinicalPrincipal InvestigatorCalifornia, United States
3 Previous Clinical Trials
165 Total Patients Enrolled
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