HDM1005 for adults with Type 2 diabetes not controlled by diet/exercise or metformin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Lepeng Li
• Email: lilepeng@eastchinapharm.com
• Phone: +86 18301051549

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.