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HM-002-1005 for Type 2 Diabetes

Phase 1
Recruiting
Led By Alexander N Prezioso, MD
Research Sponsored by Hua Medicine 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 72 hour
Awards & highlights
No Placebo-Only Group

Summary

The purposes of this study are to: * Evaluate the safety and tolerability of the study drug. * Measure how much of the study drug (HM-002-1005) and its breakdown product get into the bloodstream, and how long it takes the body to get rid of them. * Measure the amount of glucose (blood sugar) and a substance called C-peptide in the bloodstream after receiving the study drug. Researchers will compare the study drug to a placebo (a look-alike substance that contains no drug). Participants will: * Stay 5 days and 4 nights or 6 days and 5 nights at the research site, and have a follow-up phone call 7 days after leaving the research site. * Take one (1) dose of the study drug or placebo * Have blood taken to measure the amount of study drug and its breakdown product and the levels of glucose and C-peptide * Have safety tests such as vital sign, ECGs, and glucose measurements

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Area under the plasma concentration versus time curve (AUC)
Incidence of adverse events
apparent terminal elimination half life (t1/2)
+2 more
Secondary study objectives
glucose concentration following single oral dose of HM-002-1005

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: HM-002-1005 61.5 mg or matching placeboExperimental Treatment1 Intervention
Single dose of 61.5 mg HM-002-1005 or matching placebo
Group II: HM-002-1005 369 mg or matching placeboExperimental Treatment1 Intervention
Single dose of 369 mg HM-002-1005 or matching placebo
Group III: HM-002-1005 184.5 or 246 mg, or matching placeboExperimental Treatment1 Intervention
Single dose of 184.5 or 246 mg HM-002-1005 or matching placebo
Group IV: HM-002-1005 123 mg or matching placeboExperimental Treatment1 Intervention
Single dose of 123 mg HM-002-1005 or matching placebo

Find a Location

Who is running the clinical trial?

Hua Medicine LimitedLead Sponsor
15 Previous Clinical Trials
3,749 Total Patients Enrolled
Alexander N Prezioso, MDPrincipal InvestigatorClinical Pharmacology of Miami
1 Previous Clinical Trials
40 Total Patients Enrolled
~27 spots leftby Nov 2025
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