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SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
SAL067
Placebo
Sponsored by
Shenzhen Salubris Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999; Men or women aged 18 to 75 years old at the day of signing the informed consent; Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)]; Subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning; Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement); Screening period and random time fasting blood glucose <=13.9mmol/L. Exclusion Criteria: Drug compliance during the introduction period <80% or >120%; Use other hypoglycemic drugs other than test drugs during the introduction period; The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin; Before screening, have any of the following endocrine-related medical history or evidence: Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly; diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lacticacidosis and other acute complications of diabetes within 6 months before screening; severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia; Before screening, there is a history or evidence of any of the following diseases: Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia; A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis.

Sites / Locations

  • Peking University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SAL067

Placebo

Arm Description

SAL067 12mg once daily

placebo once daily

Outcomes

Primary Outcome Measures

HbA1c change from baseline at week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24

Secondary Outcome Measures

HbA1c change from baseline at week 4,week 12,week 40 and week 52
Change From Baseline in Hemoglobin A1c (HbA1c) at week 4,week 12,week 40 and week 52
FPG change from baseline at week 4, week 8, week 12, week 16, week 24, week 40 and week 52
Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52
Percentage of patients required use of rescue therapy at week 24 and week 52
Fasting c-peptide change from baseline at week 24 and week 52
Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52
eatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52

Full Information

First Posted
March 10, 2023
Last Updated
March 24, 2023
Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05801627
Brief Title
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin
Official Title
A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase III Clinical Trial for the Efficacy and Safety of Fugliglitinate Benzoate Tablets in Patients With Type 2 Diabetes Who Cannot be Effectively Controlled by Metformin
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
May 24, 2022 (Actual)
Study Completion Date
May 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Salubris Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is the phase 3 randomized, double-blind, placebo-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in T2DM patients uncontrolled by metformin, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.
Detailed Description
All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 groups continued the same treatment until the end of the whole 52 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
408 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SAL067
Arm Type
Experimental
Arm Description
SAL067 12mg once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo once daily
Intervention Type
Drug
Intervention Name(s)
SAL067
Other Intervention Name(s)
SAL067 Group
Intervention Description
SAL067 6mg(2 tablet) and Metformin ≥1500mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Group
Intervention Description
Placebo (2 tablet) and Metformin ≥1500mg
Primary Outcome Measure Information:
Title
HbA1c change from baseline at week 24
Description
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24
Time Frame
Baseline and week 24
Secondary Outcome Measure Information:
Title
HbA1c change from baseline at week 4,week 12,week 40 and week 52
Description
Change From Baseline in Hemoglobin A1c (HbA1c) at week 4,week 12,week 40 and week 52
Time Frame
Baseline, week 4, week 12, week 40 and week 52
Title
FPG change from baseline at week 4, week 8, week 12, week 16, week 24, week 40 and week 52
Time Frame
Baseline, week 4, week 8, week 12, week 24, week 40 and week 52
Title
Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52
Time Frame
Baseline, week 24 and week 52
Title
Percentage of patients required use of rescue therapy at week 24 and week 52
Time Frame
Baseline, week 24 and week 52
Title
Fasting c-peptide change from baseline at week 24 and week 52
Time Frame
Baseline, week 24 and week 52
Title
Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52
Time Frame
Baseline, week 24 and week 52
Title
eatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52
Time Frame
Baseline, week 24 and week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999; Men or women aged 18 to 75 years old at the day of signing the informed consent; Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)]; Subjects treated with metformin≥ 1500mg/day constantly for at least 8 consecutive weeks before screnning; Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement); Screening period and random time fasting blood glucose <=13.9mmol/L. Exclusion Criteria: Drug compliance during the introduction period <80% or >120%; Use other hypoglycemic drugs other than test drugs during the introduction period; The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin; Before screening, have any of the following endocrine-related medical history or evidence: Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly; diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lacticacidosis and other acute complications of diabetes within 6 months before screening; severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia; Before screening, there is a history or evidence of any of the following diseases: Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of); Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia; A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Guo, Ph.D
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Hospital
City
Beijing
State/Province
Beijing
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin

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