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

Hua Medicine Limited1 site in 1 country40 target enrollmentApril 25, 2024

InterventionsHM-002-1005

Overview

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

Registry

clinicaltrials.gov

Start Date

April 25, 2024

End Date

September 6, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Hua Medicine Limited

Responsible Party

Sponsor

•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).

•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.