HDM1005 injections for adults with type 2 diabetes not controlled by diet and exercise

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, placebo-controlled Phase 3 trial will enroll 240 adults with type 2 diabetes inadequately controlled by diet and exercise to test two dose regimens of HDM1005 against placebo. Participants will be stratified by baseline HbA1c (≤8.5% or >8.5%) and randomized 1:1:1 to two HDM1005 dose groups or placebo, with dose titration used to reach target doses. The core treatment period is 36 weeks, after which participants on placebo switch to HDM1005 until week 52, followed by a 4-week follow-up for safety. The study includes up to 2-week screening, a 2-week run-in, a 16-week extension, and an end-of-study visit 28 days after the last dose.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Confirmed as Type 2 Diabetes Mellitus (T2DM) for at least 12 weeks and have not used any antihyperglycemic medications during for at least 12 weeks prior to screening.
2. Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% at screening; and ≥7.0% and ≤10.5% at randomization.
3. Body Mass Index (BMI) ≥22.5 kg/m2.

Exclusion Criteria:

1. Other types of diabetes besides T2DM.
2. Acute complications of diabetes (such as diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketoticcoma) occurred within 24 weeks prior to signing the Informed Consent Form (ICF).
3. History of a level 3 hypoglycemic episode or a history of asymptomatic hypoglycemic episodes within 24 weeks prior to signing the ICF.
4. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
5. 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.
6. 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.
7. Use of any antidiabetic medications within 12 weeks prior to signing the ICF; excluding short-term insulin use (cumulative duration ≤7 days) for concomitant illness, stress, or perioperative periods.
8. Hemoglobin (Hb) \<100 g/L (female) or \<110 g/L (male).
9. FPG ≥13.9 mmol/L.
10. Aspartate aminotransferase (AST) \>3× upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3× ULN.
11. Total bilirubin \>1.5× ULN.
12. Fasting triglyceride (TG) \>5.6 mmol/L (500 mg/dL).

Where it's running

• Chinese PLA General Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Wenyan Cao
• Email: cxycaowenyan@eastchinapharm.com
• Phone: +86 18810614389

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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.