HDM1005 for adults with Type 2 diabetes not controlled by diet/exercise or metformin
A Randomized, Double-blind, Placebo and Active Comparator-controlled Phase 2 Study to Evaluate the Efficacy and Safety of HDM1005 in Subjects With T2DM With Inadequate Glycemic Control After Diet/Exercise or Metformin Therapy
This trial will test different doses of HDM1005 versus placebo and dulaglutide in adults with Type 2 diabetes whose blood sugar isn't controlled by diet/exercise or metformin.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT07109700 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, parallel-group Phase 2 trial will enroll 216 adults with T2DM and stratify them by baseline HbA1c and prior metformin use. Participants are randomized 1:1:1:1:1:1 to four HDM1005 dose arms (0.5, 1.0, 2.0, 3.0 mg), placebo, or open-label dulaglutide 1.5 mg, with dose titration planned for the 1.0–3.0 mg cohorts. The study will measure efficacy, safety, immunogenicity and pharmacokinetics, using changes in HbA1c and safety outcomes to compare arms. Approximately 36 subjects per arm support dose-ranging decisions and comparison to an established active comparator.
Who should consider this trial
Good fit: Adults with type 2 diabetes for at least 24 weeks, HbA1c between 7.5% and 10.5%, BMI 22.5–40 kg/m2, and inadequate glycemic control on diet/exercise or metformin are the intended participants.
Not a fit: People with type 1 diabetes, recent severe hypoglycemia, history of pancreatitis, a personal or family history of medullary thyroid carcinoma or MEN2, or those already well controlled on other therapies are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If effective, HDM1005 could lower HbA1c and provide an additional treatment option for people whose diabetes is not controlled with diet/exercise or metformin.
How similar studies have performed: Dulaglutide and other GLP-1 receptor agonists have shown consistent HbA1c and weight benefits in prior trials, so this placebo- and active-controlled dose-ranging design follows an established precedent.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 24 weeks; * Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% * Body Mass Index (BMI within the range of 22.5 \~ 40.0 kg/m2 Exclusion Criteria: * 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 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 * Use of antidiabetic medications within 12 weeks prior to signing the ICF * Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male) * FPG ≥13.9 mmol/L * Aspartate aminotransferase (AST) \>2.5× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>2.5× ULN * Total bilirubin \>1.5× ULN * Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL)
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Lepeng Li
- Email: lilepeng@eastchinapharm.com
- Phone: +86 18301051549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.