To Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

NCT06481085 | Completed Phase 2 FDA Drug

• 1 other identifier: HDM1002-202
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 31

Brief Summary

This is a randomized, double-blind, placebo controlled, parallel group study, which aims to provide data on efficacy, safety and pharmacokinetics (PK) of multiple dose levels of HDM1002 tablets in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin and/or diet and exercise.

Conditions

Type 2 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in HbA1c at Week 12

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

  Baseline, Week 12

Secondary Outcomes (12)

• Change From Baseline in HbA1c at Week 4, Week 8

  Baseline, Week 4, Week 8

• Percentage of Participants With an HbA1c target value of < 7.0% or ≤ 6.5%

  Baseline, Week 12

• Change From Baseline in Fasting plasma Glucose

  Baseline, Week 12

• Change From Baseline in Postprandial 2-hour Glucose (PPG2h), Area Under the Curve of Plasma Glucose (AUC0-4h, Glucose), C-Peptide (AUC0-4h, C-peptide), Insulin (AUC0-4h, Insulin), and Glucagon (AUC0-4h, Glucagon)

  Baseline, Week 12

• Change From Baseline in Fasting C-Peptide, Fasting Insulin, and Fasting Glucagon

  Baseline, Week 12

Other Outcomes (3)

• Change From Baseline in Glycaemic Indicators According to Treatment Background ( Metformin or Diet and Exercise Alone)

  Baseline, Week 12

• Change From Baseline in Body Weight According to Treatment Background ( Metformin or Diet and Exercise Alone)

  Baseline, Week 12

• Pharmacokinetic (PK) Profiles of HDM1002 and Its Metabolites (If Feasible)

  Baseline, Day 71

Study Arms (6)

HDM1002 50 mg

EXPERIMENTAL

Participants received 50 mg HDM1002 administered orally once daily (QD)

Drug: HDM1002 50 mg

HDM1002 100 mg

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 200 mg

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 400 mg

EXPERIMENTAL

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

Drug: HDM1002 400 mg

Placebo

PLACEBO COMPARATOR

Participants received matching placebo administered orally QD

Drug: Placebo

HDM1002 200 mg bid

EXPERIMENTAL

Participants received maintenance dose 400 mg with dose escalation starting from 25 mg, 50 mg, 100 mg and then 200 mg HDM1002 administered orally twice daily (BID)

Drug: HDM1002 200 mg BID

Interventions

HDM1002 50 mg DRUG

HDM1002 tablets, 50 mg once daily, 12 weeks

Also known as: HDM1002

HDM1002 50 mg

HDM1002 100 mg DRUG

HDM1002 tablets, 100 mg once daily, 12 weeks

Also known as: HDM1002

HDM1002 100 mg

HDM1002 200 mg DRUG

HDM1002 tablets, 200 mg once daily, 12 weeks

Also known as: HDM1002

HDM1002 200 mg

HDM1002 400 mg DRUG

HDM1002 tablets, 400 mg once daily, 12 weeks

Also known as: HDM1002

HDM1002 400 mg

HDM1002 200 mg BID DRUG

HDM1002 tablets, 200 mg twice daily, 12 weeks

Also known as: HDM1002

HDM1002 200 mg bid

Placebo DRUG

Matching placebo will be provided

Also known as: Matching placebo for group A to group E

Placebo

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 (WHO 1999) and meets one of the following conditions:
• 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 6 weeks prior to screening; and must be stable for at least 12 weeks prior to randomization.
• Participants on diet and exercise alone for at least 12 weeks prior to screening will be limited to ≤20% of total participant population.
• HbA1c ≥7.5% and ≤10.5% at screening as assessed by the local laboratory, and HbA1c ≥7.5% and ≤10.5% prior to randomization as assessed by the specified central laboratory.
• Having a body mass index (BMI) of 22.5 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 informed consent form (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 before signing the ICF.
• History of level 3 hypoglycemia (as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery) , or history of asymptomatic hypoglycaemic episodes within 6 months prior to signing the ICF.
• Severe infection within 4 weeks prior to screening and may affect glucose control in the opinion of the investigator.
• Have a known self or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia or multiple endocrine neoplasia type II (MEN2).
• Evidence of uncontrolled hypothyroidism or hyperthyroidism as judged by the investigator at the time of signing the ICF, or on a stable dose of medication therapy less than 3 months, or having been expected to require dose adjustments throughout the trial.
• History of acute or chronic pancreatitis, or any high-risk factor which may lead to pancreatitis; or have symptomatic gallbladder disease within 6 months before signing the ICF.
• Any condition or disease possibly affecting gastric emptying or nutrients absorption in the opinion of the investigator, such as history of bariatric surgery or other gastrectomy, irritable bowel syndrome, dyspepsia, etc.
• Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg under stable treatments of antihypertensive drugs at screening; or previous evidence of renal artery stenosis or unstable blood pressure (including postural hypotension).
• Have had any of the following within 6 months before signing the ICF:
• 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.)；

Sponsors & Collaborators

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

Study Sites (31)

The Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, 100039, China

Location

Beijing Chaoyang Hospital Affiliated to Capital Medical University

Beijing, China

Location

Peking University Shougang Hospital

Beijing, China

Location

Cangzhou Central Hospital

Cangzhou, China

Location

The Second Hospital of Jilin University

Changchun, China

Location

The Fourth Hospital of Changsha City

Changsha, China

Location

The Third Hospital of Changsha City

Changsha, China

Location

Chengdu Second People's Hospital

Chengdu, China

Location

The Affiliated Hospital of Chengdu University

Chengdu, China

Location

Three Gorges Hospital Affiliated to Chongqing University

Chongqing, China

Location

The First Hospital of Handan City

Handan, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, China

Location

The Fourth Affiliated Hospital of Harbin Medical University

Harbin, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Huizhou Central People's Hospital

Huizhou, China

Location

Huzhou Central Hospital

Huzhou, China

Location

Jinan Central Hospital

Jinan, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

The Third People's Hospital of Luoyang City

Luoyang, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, China

Location

The First People's Hospital of Nanyang City

Nanyang, China

Location

Panjin Liaohe Oilfield General Hospital

Panjin, China

Location

The First Hospital of Qinhuangdao City

Qinhuangdao, China

Location

Suzhou Municipal Hospital

Suzhou, China

Location

The First Hospital of Shanxi Medical University

Taiyuan, China

Location

Tonghua Central Hospital

Tonghua, China

Location

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, China

Location

Xuzhou Cancer Hospital

Xuzhou, China

Location

Yueyang People's Hospital

Yueyang, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

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

Study Officials

• Yiming Mu, Ph.D

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: June 13, 2024
• First Posted: July 1, 2024
• Study Start: June 27, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (31)