Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
258 participants
INTERVENTIONAL
2015-09-30
2016-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
NCT03173391
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HMS5552 in Patients With Type 2 Diabetes
NCT02077452
A Clinical Study to Evaluate Safety, Tolerability and Pharmacokinetics of Oral HMS5552 in Healthy Volunteers
NCT01952535
Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects
NCT05966272
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects
NCT05152277
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HMS5552 dose 1
75mgQD oral administration
HMS5552
75mgQD
HMS5552 dose 2
100mgQD oral administration
HMS5552
100mgQD
HMS5552 dose 3
50mgBID oral administration
HMS5552
50mgBID
HMS5552 dose 4
75mgBID oral administration
HMS5552
75mgBID
Placebo
Placebo, BID/QD oral administration
Placebo
QD/BID
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HMS5552
75mgQD
HMS5552
100mgQD
HMS5552
50mgBID
HMS5552
75mgBID
Placebo
QD/BID
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. T2DM patients，anti-hyperglycemic drug-naïve and on diet \& exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
3. HbA1c 7.5\~10.5% at screening and pre-randomization
4. Fasting plasma glucose (FPG)7.0\~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0\~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
5. BMI: 19\~30kg/m\^2 \& TG\<5.5mmol/L
Exclusion Criteria
2. kidney diseases or eGFR MDRD\<60ml/min/1.73m\^2
3. unstable CVDs
4. liver diseases
5. mental or CNS diseases
40 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Tigermed Consulting Co., Ltd
INDUSTRY
Hua Medicine Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Dalong Zhu, MD，PhD
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Zhu D, Gan S, Liu Y, Ma J, Dong X, Song W, Zeng J, Wang G, Zhao W, Zhang Q, Li Y, Fang H, Lv X, Shi Y, Tian H, Ji L, Gao X, Zhang L, Bao Y, Lei M, Li L, Zeng L, Li X, Hou X, Zhao Y, Hu T, Ge X, Zhao G, Li Y, Zhang Y, Chen L. Dorzagliatin monotherapy in Chinese patients with type 2 diabetes: a dose-ranging, randomised, double-blind, placebo-controlled, phase 2 study. Lancet Diabetes Endocrinol. 2018 Aug;6(8):627-636. doi: 10.1016/S2213-8587(18)30105-0. Epub 2018 May 4.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HMM0201
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.