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
Long-term Efficacy and Safety of HMS5552 in T2DM Subjects
Sponsors
Source
Hua Medicine Limited
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Detailed Description
This study is a phase III study in subjects with T2DM. As designed, the study will start with
a 4-week, single-blind, placebo run-in period based on diet and exercise interventions for
screening eligible subjects. The eligible subjects are randomly assigned to HMS5552 75mg BID
group or placebo BID group with ratio 2:1 to receive a 24-week double-blind treatment. Then
all subjects receive 28-week open-label treatment of HMS5552 75mg BID . After 52-week
treatment, all investigational drugs should be discontinued, followed by 1 week for safety
evaluation.
Overall Status
Active, not recruiting
Start Date
2017-07-18
Completion Date
2019-12-31
Primary Completion Date
2019-12-30
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change from baseline in HbA1c |
24 weeks |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Enrollment
450
Condition
Intervention
Eligibility
Criteria
Inclusion Criteria:
1. Male or female, aged 18~75 years old
2. naive T2DM 3.7.5% ≤ HbA1c ≤ 11.0% at screening 4.18.5 kg/m2 < BMI < 35.0 kg/m2 at
screening;
Exclusion Criteria:
1. T1DM
2. Fasting C-peptide <1.0 ng/ml (0.33 nmol/L) at screening
3. 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
Gender
All
Minimum Age
18 Years
Maximum Age
75 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Dalong Zhu, PhD |
Principal Investigator |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
Location
Facility |
|
Hua Medicine Limited Shanghai Shanghai 201203 China |
Location Countries
Country
China
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
HMS5552
Arm Group Type
Experimental
Description
75mg BID
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
BID
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
May 30, 2017
Study First Submitted Qc
May 31, 2017
Study First Posted
June 1, 2017
Last Update Submitted
November 12, 2019
Last Update Submitted Qc
November 12, 2019
Last Update Posted
November 14, 2019
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.