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
| Sponsors |
Lead Sponsor: Hua Medicine Limited Collaborator: Tigermed Consulting Co., Ltd |
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| Source | Hua Medicine Limited | ||||||||||
| 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. |
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| 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. |
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| Overall Status | Active, not recruiting | ||||||||||
| Start Date | July 18, 2017 | ||||||||||
| Completion Date | December 31, 2020 | ||||||||||
| Primary Completion Date | December 30, 2020 | ||||||||||
| Phase | Phase 3 | ||||||||||
| Study Type | Interventional | ||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 450 | ||||||||||
| Condition | |||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: HMS5552 Description: BID Oral administration Arm Group Label: HMS5552 Other Name: Glucokinase Activator (GKA) Intervention Type: Drug Intervention Name: Placebo Description: BID Oral administration Arm Group Label: Placebo |
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| 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 |
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| Overall Official |
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| Location |
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| Location Countries |
China |
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| Verification Date |
February 2020 |
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| Responsible Party |
Type: Sponsor |
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| Has Expanded Access | No | ||||||||||
| Condition Browse | |||||||||||
| Number Of Arms | 2 | ||||||||||
| Arm Group |
Label: HMS5552 Type: Experimental Description: 75mg BID Label: Placebo Type: Placebo Comparator Description: BID |
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| Patient Data | No | ||||||||||
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
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