Type 2 Diabetes Mellitus (T2DM)Phase 1RINCT06883656
The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency
A Phase 1 study testing SAL067 in people with Type 2 Diabetes Mellitus (T2DM) and Renal Insuficiency, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Renal Insuficiency
- What is being tested?
- SAL067
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2022to 1 Nov 2022
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 75 (including 18 and 75 years old), both male and female;
- Weight: male ≥ 50 kg, female ≥ 45 kg; BMI in the range of 18 to 30 kg/m2 (including 18 and 30 kg/m2);
- During screening, the glomerular filtration rate (GFR) met the staging criteria of renal insufficiency or normal renal function in the corresponding group;
- The subjects can communicate well with the researchers, fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent.
- During screening, the investigators judged that the kidney disease of the subjects was stable from 4 weeks before screening to the end of the study, and GFR did not change significantly;
- Patients who had not taken or were on stable medication for renal insufficiency and/or other comorbiditions during the 4 weeks prior to screening and agreed to continue treatment during the study period;
- Patients with diabetes who have not used hypoglycemic drugs in the 4 weeks prior to screening, or who are receiving stable antidiabetic therapy (including lifestyle interventions, use of stable doses of drugs, except for prohibited drugs described in the trial protocol) and agree to continue treatment during the study period.
Who cannot join
- People who are known to be allergic to DPP-4 inhibitors or drug excipients in this study;
- Previous medication history:
- Use of DPP-4 enzyme inhibitors or similar within 2 weeks prior to screening;
- Inhibitors or inducers of the CYP 2D6 enzyme used within 30 days prior to screening or required during the trial;
- Vaccination within 4 weeks prior to screening;
- Pregnant or lactating women; The subject and his or her spouse or partner have plans to become pregnant, or plan to donate sperm or eggs, or do not agree to an acceptable and effective method of contraception within 3 months of dosing;
- Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antigen antibody composite test any item is positive。
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency and Matched Healthy Volunteers with Normal Renal Function
The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.
- Being tested
- SAL067
- 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
Fasting oral test drug 12mg
| Study group | Role | What they receive |
|---|---|---|
| healthy subject | Active comparator | Matched healthy subjects Receives: Drug: SAL067 |
| Mild renal insufficiency | Experimental | Mild renal insufficiency was GFR by 60 to 89 mL/min. Receives: Drug: SAL067 |
| Moderate renal insufficiency | Experimental | Moderate renal insufficiency was GFR by 30 to 59 mL/min. Receives: Drug: SAL067 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic characteristics
Peak blood concentration (Cmax)
Measured: 8 day
Pharmacokinetic characteristics
Area under the curve from 0 to the last time point t (AUC0-last)
Measured: 8 day
Pharmacokinetic characteristics
Area under the curve from 0 to infinity (AUC0-inf)
Measured: 8 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Mar 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883656
- Sponsor's protocol ID
- SAL067-C-011
- Other IDs
- CTR20212745
- Acronym
- RI
- Status last verified
- Mar 2025
- First submitted
- 3 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen Y, Hu C, Cao X, Men Y, Wang Y, Zhang R, Guan H, Shi L, Liu F, Miao J. Pharmacokinetics, Pharmacodynamics and Safety of Fultagliptin Benzoate Tablets, a DPP-4 Inhibitor, in Patients With Varying Degrees of Renal Insufficiency and Matched Healthy Volunteers: A Phase I Clinical Trial. Clin Pharmacokinet. 2026 Apr;65(4):545-556. doi: 10.1007/s40262-026-01622-8. Epub 2026 Feb 9.
PubMed 41661440
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics Study of Fotagliptin in Patients with Different Degrees of Renal Insufficiency and Matched Healthy Volunteers with Normal Renal Function
- ClinicalTrials.gov ID
- NCT06883656
- Acronym / sponsor ID
- RI / SAL067-C-011
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 Mar 2025 (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.
The trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. The study of patients were mild and moderate renal insufficiency, and matched healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy subject | Active comparator | Drug: SAL067Matched healthy subjects |
| Mild renal insufficiency | Experimental | Drug: SAL067Mild renal insufficiency was GFR by 60 to 89 mL/min. |
| Moderate renal insufficiency | Experimental | Drug: SAL067Moderate renal insufficiency was GFR by 30 to 59 mL/min. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 to 75 (including 18 and 75 years old), both male and female;
- Weight: male ≥ 50 kg, female ≥ 45 kg; BMI in the range of 18 to 30 kg/m2 (including 18 and 30 kg/m2);
- During screening, the glomerular filtration rate (GFR) met the staging criteria of renal insufficiency or normal renal function in the corresponding group;
- The subjects can communicate well with the researchers, fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent.
- During screening, the investigators judged that the kidney disease of the subjects was stable from 4 weeks before screening to the end of the study, and GFR did not change significantly;
Key exclusion criteria (7 listed)
- People who are known to be allergic to DPP-4 inhibitors or drug excipients in this study;
- Previous medication history:
- Vaccination within 4 weeks prior to screening;
- Pregnant or lactating women; The subject and his or her spouse or partner have plans to become pregnant, or plan to donate sperm or eggs, or do not agree to an acceptable and effective method of contraception within 3 months of dosing;
- Hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, HIV antigen antibody composite test any item is positive。
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 |
|---|---|---|
| SAL067Fasting oral test drug 12mg | Drug | Mild renal insufficiency, Moderate renal insufficiency, healthy subject |
Primary outcome
Pharmacokinetic characteristics
Time frame: 8 day
Peak blood concentration (Cmax)
Pharmacokinetic characteristics
Time frame: 8 day
Area under the curve from 0 to the last time point t (AUC0-last)
Pharmacokinetic characteristics
Time frame: 8 day
Area under the curve from 0 to infinity (AUC0-inf)
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 19 Mar 2025.
- Derived from this study: PubMed 41661440Chen Y, Hu C, Cao X, Men Y, Wang Y, Zhang R, Guan H, Shi L, Liu F, Miao J. Pharmacokinetics, Pharmacodynamics and Safety of Fultagliptin Benzoate Tablets, a DPP-4 Inhibitor, in Patients With Varying Degrees of Renal Insufficiency and Matched Healthy Volunteers: A Phase I Clinical Trial. Clin Pharmacokinet. 2026 Apr;65(4):545-556. doi: 10.1007/s40262-026-01622-8. Epub 2026 Feb 9.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus (T2DM)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 2
A Phase 2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SAL0150 Tablets in Subjects With Type 2 Diabetes Mellitus
Type 2 Diabetes Mellitus (T2DM), Type 2 Diabetes
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SAL067 in people with Type 2 Diabetes Mellitus (T2DM) and Renal Insuficiency, 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 7 inclusion and 7 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 19 Mar 2025. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Pharmacokinetic characteristics (time frame: 8 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06883656, which also lists 1 linked publication.
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 19 Mar 2025.