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New treatment option for Type 2 Diabetes
Official title A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin
ClinicalTrials.gov ID: NCT07109700
What this study is testing
What is HDM1005 1?
HDM1005 1 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type 2 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a multicenter, randomized, double-blind (with open-label dose levels and active comparator), parallel-group, placebo- and active-controlled Phase 2 clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic (PK) characteristics of HDM1005 in subjects with Type 2 Diabetes Mellitus (T2DM) who have inadequate glycemic control after diet/exercise or metformin therapy. A total of 216 subjects will be enrolled.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Investigator determines that the subject has a condition or disease affecting gastric emptying or gastrointestinal nutrient absorption, such as...
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.