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HM15136 for Congenital Hyperinsulinism
Phase 2
Recruiting
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
Previously undergone near-total pancreatectomy or being treated with a nonsurgical approach, having been evaluated as not eligible for pancreatic surgery
Male and female subjects aged ≥2 years with CHI with persistent hypoglycemia despite current SoC treatment according to the investigator's evaluation or documentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after multiple subcutaneous (sc) doses of 8 weeks
Awards & highlights
Study Summary
This trial will test a new drug to see if it's safe and works well to treat people with a certain type of diabetes who have low blood sugar. The drug will be given once a week in different doses to people of different ages.
Who is the study for?
This trial is for individuals aged 2 years or older with Congenital Hyperinsulinism who still have low blood sugar despite current treatments. They may have had surgery or be managed without it, and must not have diabetes or use medications that affect blood sugar levels.Check my eligibility
What is being tested?
The study tests HM15136 as an additional weekly treatment to see if it's safe and effective in managing low blood sugar in patients with CHI. It will also look at how the body processes the drug across different ages.See study design
What are the potential side effects?
While specific side effects of HM15136 are not listed, common concerns may include reactions at injection sites, potential liver issues, and possible interactions with other drugs affecting glucose metabolism.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had most of my pancreas removed or am being treated without surgery because I can't have pancreatic surgery.
Select...
I am 2 years or older with CHI and still have low blood sugar despite treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after multiple subcutaneous (sc) doses of 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after multiple subcutaneous (sc) doses of 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Serum Concentration [Cmax]
Number of incidence of AEs, TEAE, SAE as assessed by CTCAE v5.0
Number of incidence of clinical laboratory abnormalities
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: HM15136 activeExperimental Treatment1 Intervention
Cohort 1 / Cohort 2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HM15136
2019
Completed Phase 1
~100
Find a Location
Who is running the clinical trial?
Hanmi Pharmaceutical Company LimitedLead Sponsor
190 Previous Clinical Trials
61,089 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on a stable standard treatment plan, with or without extra nutrition.I've had CHI treatment with IV glucose or glucagon in the last 3 months.I have had most of my pancreas removed or am being treated without surgery because I can't have pancreatic surgery.My low blood sugar is not caused by medications or other known reasons.I am 2 years or older with CHI and still have low blood sugar despite treatment.I am not currently using any medications that could affect the study drug or my blood sugar levels.Your HbA1c level is less than 7%.I have type 1 or type 2 diabetes.I have a condition that can affect my blood sugar levels.
Research Study Groups:
This trial has the following groups:- Group 1: HM15136 active
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to participate in this research currently available?
"Affirmative. The details on clinicaltrials.gov affirms that this medical trial is currently recruiting patients, having initially been posted on October 28th 2021 and modified most recently in September 26th 2022. A total of 16 participants are required from 3 distinct sites."
Answered by AI
How many individuals can participate in this trial at its peak?
"In order to commence the trial, 16 individuals who meet its eligibility criteria are required. Hanmi Pharmaceutical Company Limited is the sponsor and will be overseeing proceedings at various clinical sites such as Washington University School of Medicine in Saint Louis, Missouri and The Children's Hospital of Philadelphia in Pennsylvania."
Answered by AI
What can be said of the safety profile associated with HM15136?
"Our evaluation of HM15136's safety is a 2, signifying that although there are some preliminary data supporting its safety, no studies have yet proven efficacy."
Answered by AI
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