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

Recruiting Phase 3 Interventional Study
Type 2 Diabetes
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
240 (estimated)
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
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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…
Trial Locations
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Eligibility Criteria
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…
Contacts

Wenyan Cao

+86 18810614389

cxycaowenyan@eastchinapharm.com

CONTACT