Diabetes Mellitus, Type 2Phase 3NCT05801627
SAL067 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled by Metformin
A Phase 3 study testing SAL067 in people with Diabetes Mellitus, Type 2, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- SAL067
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 6 May 2020to 24 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- SAL067, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL067Drug
Also called SAL067 Group
SAL067 6mg(2 tablet) and Metformin ≥1500mg
PlaceboDrug
Also called Placebo Group
Placebo (2 tablet) and Metformin ≥1500mg
| Study group | Role | What they receive |
|---|---|---|
| SAL067 | Experimental | SAL067 12mg once daily Receives: Drug: SAL067 |
| Placebo | Placebo comparator | placebo once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c change from baseline at week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24
Measured: Baseline and week 24
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: Baseline, week 24 and week 52
Percentage of patients required use of rescue therapy at week 24 and week 52
Measured: Baseline, week 24 and week 52
Fasting c-peptide change from baseline at week 24 and week 52
Measured: Baseline, week 24 and week 52
Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52
Measured: Baseline, week 24 and week 52
eatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52
Measured: Baseline, week 24 and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start6 May 2020
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Shenzhen Salubris Pharmaceuticals Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaohui Guo, Ph.D, Principal investigator, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801627
- Sponsor's protocol ID
- SAL067-C-008
- Other IDs
- CTR20200061, ChiCTR2000033616
- Status last verified
- Mar 2023
- First submitted
- 10 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05801627
- Acronym / sponsor ID
- SAL067-C-008
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2020 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SAL067 | Experimental | Drug: SAL067SAL067 12mg once daily |
| Placebo | Placebo comparator | Drug: Placeboplacebo once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (11 listed)
- 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:
- Before screening, there is a history or evidence of any of the following diseases:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAL067Also: SAL067 GroupSAL067 6mg(2 tablet) and Metformin ≥1500mg | Drug | SAL067 |
| PlaceboAlso: Placebo GroupPlacebo (2 tablet) and Metformin ≥1500mg | Drug | Placebo |
Primary outcome
HbA1c change from baseline at week 24
Time frame: Baseline and week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24
7 secondary outcomes
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
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
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
Percentage of patients required use of rescue therapy at week 24 and week 52
Time frame: 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
Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaohui Guo, Ph.D principal investigator
Peking University First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SAL067 in people with Diabetes Mellitus, Type 2, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c change from baseline at week 24 (time frame: Baseline and week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.