Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type II

In brief

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

Key facts

Study ID

NCT06498284

Run by

Hua Medicine Limited

People needed

40

Starts

2024-04-25

Expected to finish

2024-09-06

Last updated by the study team

2025-04-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clinical Pharmacology of Miami — Hialeah, Florida, United States

Full record on ClinicalTrials.gov

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