A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

NCT07082114 | Recruiting Phase 3 FDA Drug

• 1 other identifier: HDM1002-303
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.

Conditions

Type 2 Diabetes

Keywords

Glucagon-Like Peptide-1 Receptor Agonists; HDM1002 tablet; type 2 diabetes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 40

  HbA1c can be used as a diagnostic test for diabetes and is a widely recognized objective measure of glycemic control

  Baseline, Week 40

Secondary Outcomes (15)

• Change From Baseline in HbA1c at Week 52

  Baseline, Week 52

• Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5% with or without confirmed (plasma glucose <3.9 mmol/L) symptomatic hypoglycemia

  Baseline, Week 40, Week 52

• Change From Baseline in Fasting plasma Glucose

  Baseline, Weeks 40, Week 52

• Change from baseline in fasting C-peptide and fasting insulin

  Baseline, Weeks 40, Week 52

• Change from baseline in homeostasis model assessment of β-cell function (HOMA-β) and insulin resistance (HOMA-IR)

  Baseline, Weeks 40, Week 52

Study Arms (4)

HDM1002 100mg

EXPERIMENTAL

Participants received maintenance dose of 100 mg with dose escalation starting from 50 mg HDM1002 administered orally once daily (QD)

Drug: HDM1002 100 mg

HDM1002 200mg

EXPERIMENTAL

Participants received maintenance dose 200 mg with dose escalation starting from 50 mg, 100 mg and then 200 mg HDM1002 administered orally QD

Drug: HDM1002 200 mg

HDM1002 400mg

EXPERIMENTAL

Participants received maintenance dose 400 mg with dose escalation starting from 50 mg, 100 mg, 200 mg and then 400 mg HDM1002 administered orally QD

Drug: HDM1002 400 mg

Dapagliflozin

ACTIVE COMPARATOR

Participants received dapagliflozin 10 mg administered orally QD

Drug: Dapagliflozin (DAPA)

Interventions

HDM1002 100 mg DRUG

HDM1002 tablets, 100 mg once daily, 52 weeks

Also known as: HDM1002

HDM1002 100mg

HDM1002 200 mg DRUG

HDM1002 tablets, 200 mg once daily, 52 weeks

Also known as: HDM1002

HDM1002 200mg

HDM1002 400 mg DRUG

HDM1002 tablets, 400 mg once daily, 52 weeks

Also known as: HDM1002

HDM1002 400mg

Dapagliflozin (DAPA) DRUG

dapagliflozin 10mg will be provided

Also known as: Dapagliflozin

Dapagliflozin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects between 18 and 75 years of age (inclusive).
• Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization, and participants treated with a stable dose of metformin (with maintenance dose of at least 1500 mg/day or a maximally tolerated dose not less than 1000 mg) for at least 8 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.
• HbA1c ≥7.5% and ≤11.0% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤11.0% prior to randomization as assessed by the specified central laboratory.
• Having a body mass index (BMI) of 19.0 to 40.0 kg/m2, inclusive.
• Female participants of childbearing potential and male participants must agree to use highly effective contraception method from the day of signing the ICF and until 30 days (female) or 90 days (male) after the final dose administration.
• Able to understand and comply with protocol requirements, agree to maintain the same dietary and exercise habits throughout the trial, be willing to complete the trial in strict compliance with the clinical trial protocol and provide written informed consent.

You may not qualify if:

• Diagnosed with type 1 diabetes mellitus (including latent autoimmune diabetes in adults), special types of diabetes or gestational diabetes mellitus
• Evidence of acute complications of diabetes (e.g., diabetic ketoacidosis, diabetic lactosidosis, or hyperosmolar nonketotic coma) within 6 months prior to signing the informed consent form (ICF).
• Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2)
• History of acute or chronic pancreatitis or pancreatic injury, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease that requires treatment during the trial (subjects with prior cholecystectomy can be enrolled if deemed eligible by the investigator)
• Have had dysphagia, or any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of surgery affecting gastric emptying, gastroesophageal reflux disease, pyloric obstruction, irritable bowel syndrome, etc.
• Have had any of the following within 3 months prior to screening:
• Unstable angina；
• Heart failure (New York Heart Association, class III or IV);
• Myocardial infarction (MI)；
• Coronary artery bypass grafting or percutaneous coronary intervention；
• Uncontrolled severe arrhythmias (including: ventricular tachycardia, ventricular fibrillation, atrial fibrillation, second to third degree atrioventricular block, sick sinus node syndrome, pre-excitation syndrome, etc.)；
• Cerebrovascular accident
• Have a history of proliferative diabetic retinopathy and/or diabetic maculopathy that requires treatment, or evidence of other severe retinopathy that requires treatment during the study.
• Have a known history of liver disease, including: acute or chronic active liver disease (except non-alcoholic steatohepatitis) such as active hepatitis B, hepatitis C; or primary biliary cholangitis.
• Used strong CYP3A4 or P-gp inhibitors within 14 days prior to randomization or 5 half-lives (whichever is longer); current use with strong/moderate CYP3A4 inhibitors or strong P-gp inducers that cannot be discontinued during the trial; any prior use OATP1B1/OATP1B3 inhibitors; current use with narrow therapeutic index drugs that are substrates of CYP2C8, CYP3A4, UGT1A1, P-gp, or OATP1B1/OATP1B3 and cannot be discontinued during the trial.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Yueyang People's Hospital

Yueyang, Hunan, 414000, China

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 24, 2025
• Study Start: July 14, 2025
• Primary Completion (Estimated): February 16, 2027
• Study Completion (Estimated): May 17, 2027
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)