Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hua Medicine Limited
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Males or females, of any race, between 18 and 65 years of age, inclusive.
2. Body mass index between 18.5 and 38.0 kg/m2, inclusive.
3. Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
4. Type 2 diabetes mellitus, as determined by the American Diabetes Association (ADA) Standard Care Diagnostic Criteria 2023, and
1. are drug naïve, treated with diet and exercise, or
2. have been on a stable dose of ≤2000 mg metformin for ≥1 month, or
3. have been on a stable dose of antidiabetic medications (other than metformin) for ≥90 days.
5. 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).
6. Glycated hemoglobin between 6.5% and 9.5%, inclusive.
7. 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
8. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
You may not be if
1. 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).
2. Diabetic neuropathy, retinopathy, or nephropathy.
3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis.
4. 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.
5. Hypoglycemia unawareness or asymptomatic hypoglycemia.
6. Clinically significant history of liver disease (eg, hepatitis and cirrhosis) within 1 year prior to screening.
7. Clinically significant history of renal disease. Mild to moderate chronic kidney disease is permitted.
8. 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.
9. 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.
10. Clinically significant gastric emptying abnormality (eg, severe diabetic gastroparesis or gastric outlet obstruction) or have had gastric bypass surgery.
11. 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).
12. Known or active malignancy, except basal cell carcinoma and cutaneous squamous cell carcinoma.
13. Any hospital admission or major surgery within 90 days prior to screening.
14. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator (or designee).
15. Fasting C peptide \<0.81 ng/mL.
16. Alanine aminotransferase, aspartate aminotransferase, or gamma glutamyl transferase \>2 × the upper limit of normal (ULN); or total bilirubin \>1.5× ULN.
18. Estimated glomerular filtration rate ≤45 mL/min/1.73 m2, as calculated using the 2021 Chronic Kidney Disease Epidemiology equation.
19. QT interval corrected for heart rate using Fridericia's method \>450 msec.
20. Positive hepatitis panel and/or positive human immunodeficiency virus test .
21. Positive pregnancy test.
22. Use of insulin, sulfonylureas, and glinides (eg, repaglinide and nateglinide).
23. 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.
24. 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
26. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days.
27. Positive alcohol test result, or positive urine drug screen (confirmed by repeat), or positive cotinine test at screening or check in.
28. 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.
29. 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.
30. Use of tobacco or nicotine containing products within 6 months prior to check in.
31. Receipt or donation of \>1 unit (approximately 450 mL) of blood products within 3 months prior to screening.
32. Poor peripheral venous access.
33. Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Clareo Health | Evaluate HM-002-1005 in Subjects With Type 2 Diabetes Mellitus
