Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
A 24-week Multi-center, Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HMS5552 With Additional 28-week Open-label Treatment to Evaluate the Safety of HMS5552 Alone in T2DM Subjects
1 other identifier
interventional
463
1 country
1
Brief Summary
This study evaluates the efficacy and safety and population PK of HMS5552 as monotherapy in adult type 2 diabetic subjects, there will be 2 groups in the first 24 weeks, one group will receive HMS5552 , while the other group will receive placebo ; after 24 weeks, all subjects will receive HMS5552 for 28 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 diabetes-mellitus-type-2
Started Jul 2017
Longer than P75 for phase_3 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2017
CompletedFirst Posted
Study publicly available on registry
June 1, 2017
CompletedStudy Start
First participant enrolled
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2020
CompletedAugust 26, 2021
November 1, 2020
3.4 years
May 30, 2017
August 24, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in HbA1c
The change of HbA1c from baseline in T2DM subjects after 24-week double-blind treatment
24 weeks
Secondary Outcomes (4)
The change of 2-hour postprandial plasma glucose (2h-PPG) from baseline
24 weeks
The change of fasting plasma glucose (FPG) from baseline
24 weeks
The proportion of subjects with HbA1c < 7.0%
24 weeks
Incidence of Treatment-Emergent Adverse Events over time
52 weeks
Study Arms (2)
HMS5552
EXPERIMENTAL75mg BID
Placebo
PLACEBO COMPARATORBID
Interventions
Eligibility Criteria
You may qualify if:
- Male or female, aged 18\~75 years old
- naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 \< BMI \< 35.0 kg/m2 at screening;
You may not qualify if:
- T1DM
- Fasting C-peptide \<1.0 ng/ml (0.33 nmol/L) at screening
- Medical history of severe hypoglycemia, diabetic ketoacidosis, diabetes lactic acidosis or hyperosmotic nonketotic diabetic coma, severe cardio-cerebrovascular,unstable or rapidly progressive kidney disease, active liver diseases,diagnosed mental disease,etc
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hua Medicine Limitedlead
- Tigermed Consulting Co., Ltdcollaborator
Study Sites (1)
Hua Medicine Limited
Shanghai, Shanghai Municipality, 201203, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dalong Zhu, PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2017
First Posted
June 1, 2017
Study Start
July 18, 2017
Primary Completion
November 30, 2020
Study Completion
November 30, 2020
Last Updated
August 26, 2021
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share