Diabetes Mellitus, Type IIPhase 1NCT06498284
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
A Phase 1 study testing HM-002-1005 in people with Diabetes Mellitus, Type II, run by Hua Medicine Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- HM-002-1005
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2024to 6 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, of any race, between 18 and 65 years of age, inclusive.
- Body mass index between 18.5 and 38.0 kg/m2, inclusive.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Type 2 diabetes mellitus, as determined by the American Diabetes Association (ADA) Standard Care Diagnostic Criteria 2023, and
- are drug naïve, treated with diet and exercise, or
- have been on a stable dose of ≤2000 mg metformin for ≥1 month, or
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- have been on a stable dose of antidiabetic medications (other than metformin) for ≥90 days.
- Except for findings consistent with T2DM, in good health, determined from medical history, 12 lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the investigator (or designee).
- Glycated hemoglobin between 6.5% and 9.5%, inclusive.
- Fasting plasma glucose between 126 and 196 mg/dL (7 and 11 mmol/L, respectively), inclusive. Testing may be repeated once, at the discretion of the investigator (or designee).
- Other Inclusions
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- Type 1 diabetes mellitus, maturity onset diabetes of the young, or diabetes mellitus caused by damage to the pancreas or any other condition (eg, acromegaly or Cushing's syndrome).
- Diabetic neuropathy, retinopathy, or nephropathy.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- History of severe hypoglycemia, defined as severe cognitive impairment requiring external assistance for recovery within 3 months prior to dosing; or recurrent hypoglycemia (Level 2), defined as ≥2 episodes within 3 months prior to dosing; or ADA Level 3 hypoglycemia within 6 months prior to dosing.
- Hypoglycemia unawareness or asymptomatic hypoglycemia.
- Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening.
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- Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted.
- Clinically significant history of cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart disease within 1 year prior to screening. Managed hypertension is permitted.
- Clinically significant history of any central nervous system disease, including transient ischemic attack, stroke, seizure disorder, depression, or behavioral disturbances within 1 year prior to screening.
- Clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have had gastric bypass surgery.
- Clinically significant or unstable history of any hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Known or active malignancy, except basal cell carcinoma and cutaneous squamous cell carcinoma.
- Any hospital admission or major surgery within 90 days prior to screening.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
- Fasting C peptide <0.81 ng/mL.
- Alanine aminotransferase, aspartate aminotransferase, or gamma glutamyl transferase >2 × the upper limit of normal (ULN); or total bilirubin >1.5× ULN.
- Uncontrolled hypertriglyceridemia >500 mg/dL.
- Estimated glomerular filtration rate ≤45 mL/min/1.73 m2, as calculated using the 2021 Chronic Kidney Disease Epidemiology equation.
- QT interval corrected for heart rate using Fridericia's method >450 msec.
- Positive hepatitis panel and/or positive human immunodeficiency virus test .
- Positive pregnancy test.
- Use of insulin, sulfonylureas, and glinides (eg, repaglinide and nateglinide).
- Use of any strong or moderate cytochrome P450 (CYP) 3A4 inducers within 28 days prior to dosing or any strong or moderate CYP3A4 inhibitors within 7 days or 5 half lives, whichever is longer, prior to dosing.
- Use of any P glycoprotein inducers within 14 days prior to dosing or any P glycoprotein inhibitors within 5 days or 5 half lives, whichever is longer, prior to dosing
- Use of any carboxylesterase 2 inhibitors within 5 days or 5 half lives, whichever is longer, prior to dosing Note: The use of hypertensive therapies is permitted, providing that they are do not meet exclusion criteria 22 to 25.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days.
- Positive alcohol test result, or positive urine drug screen (confirmed by repeat), or positive cotinine test at screening or check in.
- Current drug abuse, defined as the use of any illegal substance or misuse or excessive used of over the counter or prescription drugs; or current alcohol abuse, defined as the inability to stop or control alcohol use, despite adverse social or health consequences.
- Consumption of alcohol, or caffeine containing foods or beverages within 48 hours, or foods and beverages containing grapefruit or Seville oranges within 7 days prior to check in.
- Use of tobacco or nicotine containing products within 6 months prior to check in.
- Receipt or donation of >1 unit (approximately 450 mL) of blood products within 3 months prior to screening.
- Poor peripheral venous access.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami
Hialeah, Florida, 33014
About this study
Official title: HM-002-1005 - A Phase 1, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Subjects With Type 2 Diabetes Mellitus
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.
Read more
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
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- HM-002-1005
- Keywords
- Glucokinase agonist, HM-002-1005, Hyperglycemia, Diabetes Mellitus, Type II, Single dose escalation
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HM-002-1005Drug
Also called 1005
HM-002-1005 extended release tablets for oral administration compared with matching placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| HM-002-1005 61.5 mg or matching placebo | Experimental | Single dose of 61.5 mg HM-002-1005 or matching placebo Receives: Drug: HM-002-1005 |
| HM-002-1005 123 mg or matching placebo | Experimental | Single dose of 123 mg HM-002-1005 or matching placebo Receives: Drug: HM-002-1005 |
| HM-002-1005 184.5 or 246 mg, or matching placebo | Experimental | Single dose of 184.5 or 246 mg HM-002-1005 or matching placebo Receives: Drug: HM-002-1005 |
| HM-002-1005 369 mg or matching placebo | Experimental | Single dose of 369 mg HM-002-1005 or matching placebo Receives: Drug: HM-002-1005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
incidence and severity of adverse events from Day1 to Day 11
Measured: 11 Days
Area under the plasma concentration versus time curve (AUC)
area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma
Measured: 72 hour
maximum observed concentration (Cmax)
Cmax of HM-002-1005 in plasma
Measured: 72 hours
time of the maximum observed concentration (Tmax)
Tmax of HM-002-1005 in plasma
Measured: 72 hours
apparent terminal elimination half life (t1/2)
t1/2 of HM-002-1005 in plasma
Measured: 72 hours
Secondary outcomes (1)
glucose concentration following single oral dose of HM-002-1005
serum glucose concentration over 24 hours after dosing
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start25 Apr 2024
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single oral dose escalation study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hua Medicine Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander N Prezioso, MD, Principal investigator, Clinical Pharmacology of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498284
- Sponsor's protocol ID
- HMM0125
- Status last verified
- Mar 2025
- First submitted
- 30 Apr 2024
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HM-002-1005 - A Phase 1, Randomized, Double Blind, Placebo Controlled, Single Dose, Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Subjects With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06498284
- Acronym / sponsor ID
- HMM0125
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- Glucokinase agonist, HM-002-1005, Hyperglycemia, Diabetes Mellitus, Type II, Single dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hua Medicine LimitedIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- single oral dose escalation study
| Arm | Type | Receives |
|---|---|---|
| HM-002-1005 61.5 mg or matching placebo | Experimental | Drug: HM-002-1005Single dose of 61.5 mg HM-002-1005 or matching placebo |
| HM-002-1005 123 mg or matching placebo | Experimental | Drug: HM-002-1005Single dose of 123 mg HM-002-1005 or matching placebo |
| HM-002-1005 184.5 or 246 mg, or matching placebo | Experimental | Drug: HM-002-1005Single dose of 184.5 or 246 mg HM-002-1005 or matching placebo |
| HM-002-1005 369 mg or matching placebo | Experimental | Drug: HM-002-1005Single dose of 369 mg HM-002-1005 or matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Males or females, of any race, between 18 and 65 years of age, inclusive.
- Body mass index between 18.5 and 38.0 kg/m2, inclusive.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Type 2 diabetes mellitus, as determined by the American Diabetes Association (ADA) Standard Care Diagnostic Criteria 2023, and
- Except for findings consistent with T2DM, in good health, determined from medical history, 12 lead electrocardiogram (ECG), vital signs measurements, clinical laboratory evaluations, and physical examinations at screening and/or check in, as assessed by the investigator (or designee).
Key exclusion criteria (33 listed)
- Type 1 diabetes mellitus, maturity onset diabetes of the young, or diabetes mellitus caused by damage to the pancreas or any other condition (eg, acromegaly or Cushing's syndrome).
- Diabetic neuropathy, retinopathy, or nephropathy.
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
- History of severe hypoglycemia, defined as severe cognitive impairment requiring external assistance for recovery within 3 months prior to dosing; or recurrent hypoglycemia (Level 2), defined as ≥2 episodes within 3 months prior to dosing; or ADA Level 3 hypoglycemia within 6 months prior to dosing.
- Hypoglycemia unawareness or asymptomatic hypoglycemia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HM-002-1005Also: 1005HM-002-1005 extended release tablets for oral administration compared with matching placebo tablets | Drug | HM-002-1005 123 mg or matching placebo, HM-002-1005 184.5 or 246 mg, or matching placebo, HM-002-1005 369 mg or matching placebo, HM-002-1005 61.5 mg or matching placebo |
Primary outcome
Incidence of adverse events
Time frame: 11 Days
incidence and severity of adverse events from Day1 to Day 11
Area under the plasma concentration versus time curve (AUC)
Time frame: 72 hour
area under the concentration-time curve from time 0 to 72 hours postdose of HM-002-1005 in plasma
maximum observed concentration (Cmax)
Time frame: 72 hours
Cmax of HM-002-1005 in plasma
time of the maximum observed concentration (Tmax)
Time frame: 72 hours
Tmax of HM-002-1005 in plasma
apparent terminal elimination half life (t1/2)
Time frame: 72 hours
t1/2 of HM-002-1005 in plasma
1 secondary outcome
glucose concentration following single oral dose of HM-002-1005
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander N Prezioso, MD principal investigator
Clinical Pharmacology of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HM-002-1005 in people with Diabetes Mellitus, Type II, run by Hua Medicine Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 11 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.