TrialBridgeNCT07417306
A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor
Not Yet Recruiting · Phase 3 · Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · registry updated 2026-02-18
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study is a multicenter, randomized, open-label, parallel-group, phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus active comparator in subjects with Type 2 Diabetes Mellitus (T2DM) Inadequate Glycemic Control by Metformin Monotherapy or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. A total of 912 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and metformin monotherapy (yes or no), then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (active comparator), with 304 subjects in each treatment group. All treatment groups will implement dose titration to achieve the target dose. The study consists of: up to 2-week screening, 2-week run-in, 40-week core treatment, 12-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.
Inclusion
- Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and on a stable dosage of metformin alone or in combination with an SGLT2 inhibitor for at least 12 weeks prior to screening.
- Hemoglobin A1c (HbA1c) ≥7.5% and ≤11.0% (local laboratory) at screening; and ≥7.0% and ≤11.0% (central laboratory) at randomization.
- Body Mass Index (BMI) ≥22.5 kg/m2.
Exclusion
- Other types of diabetes besides T2DM.
- Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic coma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).
- History of a level 3 hypoglycemic episode or a history of asymptomatic hyp oglycemic episodes within 24 weeks prior to signing the ICF.
- History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- History of acute or chronic pancreatitis; or presence of risk factors for pancreatitis; or history of symptomatic gallbladder disease requiring treatment per investigator's assessment within 24 weeks prior to signing the ICF.
- Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as weight-loss surgery or other gastric resections, irritable bowel syndrome, dyspepsia, or gastroparesis.