- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05801627
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin
March 24, 2023 updated by: Shenzhen Salubris Pharmaceuticals Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
408
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beijing
-
Beijing, Beijing, China
- Peking University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SAL067
SAL067 12mg once daily
|
SAL067 6mg(2 tablet) and Metformin ≥1500mg
Other Names:
|
Placebo Comparator: Placebo
placebo once daily
|
Placebo (2 tablet) and Metformin ≥1500mg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c change from baseline at week 24
Time Frame: Baseline and week 24
|
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24
|
Baseline and week 24
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c change from baseline at week 4,week 12,week 40 and week 52
Time Frame: Baseline, 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
|
Baseline, 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
Time Frame: Baseline, week 4, week 8, week 12, week 24, week 40 and week 52
|
Baseline, week 4, week 8, week 12, week 24, week 40 and week 52
|
|
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
|
Baseline, week 24 and week 52
|
|
Percentage of patients required use of rescue therapy at week 24 and week 52
Time Frame: Baseline, week 24 and week 52
|
Baseline, week 24 and week 52
|
|
Fasting c-peptide change from baseline at week 24 and week 52
Time Frame: Baseline, week 24 and week 52
|
Baseline, week 24 and week 52
|
|
Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52
Time Frame: Baseline, week 24 and week 52
|
Baseline, week 24 and week 52
|
|
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
|
Baseline, week 24 and week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xiaohui Guo, Ph.D, Peking University First Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2020
Primary Completion (Actual)
May 24, 2022
Study Completion (Actual)
May 24, 2022
Study Registration Dates
First Submitted
March 10, 2023
First Submitted That Met QC Criteria
March 24, 2023
First Posted (Actual)
April 6, 2023
Study Record Updates
Last Update Posted (Actual)
April 6, 2023
Last Update Submitted That Met QC Criteria
March 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAL067-C-008
- CTR20200061 (Other Identifier: NMPA)
- ChiCTR2000033616 (Other Identifier: Chinese Clinical Trial Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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