A Phase 3 Study to Evaluate Efficacy and Safety of HDM1002 Tablets in Adults With Type 2 Diabetes Mellitus

Recruiting Phase 3 Interventional Study
Type 2 Diabetes
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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
800 (estimated)
Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Industry
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About This Trial

This is a multicenter, randomized, double-blind, active-controlled, parallel-group study, which aims to provide data on the efficacy and safety of HDM1002 tablets compared with dapagliflozin in adults with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female subjects between 18 and 75 years of age (inclusive). 2. Have been diagnosed with type 2 diabetes mellitus (T2DM) for at least 3 months based on the World Health Organization, and participants treated with a stable dose of metformin (with maintenance dose of at …
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