Status:
COMPLETED
Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
Lead Sponsor:
Hua Medicine Limited
Conditions:
Diabetes Mellitus, Type II
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
April 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06498284
Start Date
April 25 2024
End Date
September 6 2024
Last Update
April 3 2025
Active Locations (1)
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1
Clinical Pharmacology of Miami
Hialeah, Florida, United States, 33014