Menu
Recruiting NCT07109700

A Study of HDM1005 in Participants With T2DM Not Controlled With Diet/Exercise or Metformin

Phase II Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDM1005 1, HDM1005 2, HDM1005 3, HDM1005 4.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) and prior metformin use, then randomized 1:1:1:1:1:1 to: Group 1 (HDM1005 0.5 mg), Group 2 (HDM1005 1.0 mg), Group 3 (HDM1005 2.0 mg), Group 4 (HDM1005 3.0 mg), Group 5 (Placebo), and Group 6 (open-lable dulaglutide 1.5 mg, active comparator), with 36 subjects in each treatment group. Within each dose cohort (0.5/1.0/2.0/3.0mg), there will be \~45 total subjects (36 HDM1005 + 9 placebo). The 1.0mg, 2.0mg, and 3.0mg cohorts will implement dose titration. The study consists of: 2-week screening, 20-week treatment, and 4-week safety follow-up. The end-of-study visit will be conducted 28 days after the last administration cycle.

Interventions

  • Drug HDM1005 1
    administered SC, QW, 20 weeks
  • Drug HDM1005 2
    administered SC, QW, 20 weeks
  • Drug HDM1005 3
    administered SC, QW, 20 weeks
  • Drug HDM1005 4
    administered SC, QW, 20 weeks
  • Drug Placebo
    administered SC, QW, 20 weeks
  • Drug Dulaglutide 1.5 MG
    administered SC, QW, 20 weeks

Primary outcome measures

  • Change from baseline in Hemoglobin A1c (HbA1c) [Time frame: Baseline, Week 20]
Secondary outcome measures (4)
  • Change from baseline in HbA1c [Time frame: Baseline, Week 12]
  • The percentage of patients reaching the HbA1c target of ≤6.5% and of ≤7.0% [Time frame: Week 20]
  • Change frome baseline in fasting plasma glucose (FPG) [Time frame: Baseline, Week 12 and Week 20]
  • Change from baseline in body weight [Time frame: Baseline, Week 12 and Week 20]

Eligibility 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital — Beijing

Identifiers

NCT: NCT07109700 · HDM1005-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗