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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
Awards & highlights
Study Summary
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK profile of acetaminophen
Secondary outcome measures
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
Liraglutide
FDA approved
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Hanmi Pharmaceutical Company LimitedLead Sponsor
190 Previous Clinical Trials
61,061 Total Patients Enrolled
Hanmi ClinicalPrincipal InvestigatorCalifornia, United States
3 Previous Clinical Trials
165 Total Patients Enrolled
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