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A Study of HDM1005 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

ConditionType 2 Diabetes
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

This study is a multicenter, randomized, double-blind, placebo-controlled , phase 3 clinical trial aimed at evaluating the efficacy and safety of HDM1005 versus placebo in subjects with T2DM inadequate glycemic control with diet and exercise alone.

A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or \>8.5%) , then randomized 1:1:1 to: Group 1 (HDM1005), Group 2 (HDM1005), and Group 3 (placebo), with 80 subjects in each treatment group. At week 36, subjects in placebo group will receive HDM1005 injection until week 52. All treatment groups will implement dose titration to achieve the target dose.

The study consists of: up to 2-week screening, 2-week run-in, 36-week core treatment, 16-week extension treatment, and 4-week follow-up, totaling 60 weeks. The end-of-study visit will be conducted 28 days after the last administration cycle.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Hemoglobin A1c (HbA1c) ≥7.5% and ≤10.5% at screening; and ≥7.0% and ≤10.5% at randomization.

Body Mass Index (BMI) ≥22.5 kg/m2.

Disqualifiers

Other types of diabetes besides T2DM.

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).

History of a level 3 hypoglycemic episode or a history of asymptomatic hypoglycemic 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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HDM1005 1

    Drug

    administered SC, QW, 52 weeks.

  • HDM1005 2

    Drug

    administered SC, QW, 52 weeks.

  • HDM1005 injection or placebo

    Drug

    administered SC, QW, 52 weeks.

Treatment groups

240 Participants
are divided into 3 treatment groups
Group A: HDM1005 1Experimental treatment 1 intervention
Group B: HDM1005 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time.

Time frame
Baseline, Week 36

Secondary outcomes

1

Change from baseline in HbA1c

Time frame
Baseline, Week 52
2

The percentage of patients reaching the HbA1c targets of <7.0%, ≤6.5%, and <5.7%

Time frame
Week 36, Week 52
3

Change from baseline in fasting plasma glucose (FPG)

Time frame
Baseline, Week 36, Week 52
4

Change from baseline in body weight

Time frame
Baseline, Week 36, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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