Type 2 DiabetesPhase 1NCT05374343
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of Rongliflozin in Type 2 Diabetic Subjects With Renal Impairment
A Phase 1 study testing pyroglutamate rongliflozin capsules in people with Type 2 Diabetes, run by Sunshine Lake Pharma Co., Ltd. at 1 site in China.
Trial summary
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- pyroglutamate rongliflozin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2022to 24 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients.
- The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug.
- When screening, 19.0 kg/m2 < or = body mass index (BMI) < or = 35.0 kg/m2.
- No hypoglycemic drugs have been used in the 4 weeks before the baseline period, or stable doses of hypoglycemic drugs are being used.
- No medications for other comorbidities or stable medication regimens within 4 weeks before the baseline period.
- In the screening period, 6.5% < or = glycosylated hemoglobin < or =11.0%, and fasting blood glucose < or = 13.9 mmol/L.
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- Glomerular filtration rate (eGFR) > or = 90 mL/min/1.73m2 estimated according to the modified dietary trial for kidney disease (MDRD) formula (only applicable to patients with type 2 diabetes with normal renal function).
- Accompanied by mild or moderate renal impairment, the eGFR calculated according to the MDRD formula meets the following criteria: mild renal impairment: 60~89 mL/min/1.73m2, moderate renal impairment: 30~59 mL/min/ 1.73m2 (only for patients with type 2 diabetes with impaired renal function).
- Accompanied by mild or moderate renal impairment, accompanied by stable disease in the first 3 months of the baseline period (only applicable to patients with type 2 diabetes with renal impairment).
Who cannot join
- Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients.
- In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group.
- Have a history of alcoholism.
- Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug.
- Those who donate blood or lose a lot of blood (>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial.
- Those who have taken the trial drug or such drugs within 1 month before taking the trial drug, or participated in the clinical trial of any drug or medical device within 3 months before screening.
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- Those who have a positive urine drug screen or have a history of drug abuse or drug use in the past 5 years.
- The subject is breastfeeding or the serum pregnancy test result is positive.
- Subjects had undergone surgery within 1 month before screening, or major surgery was planned during the study period.
- Have severe mental illness or language barrier, unwilling or unable to fully understand and cooperate.
- History or evidence of other diseases, such as history of repeated urinary tract infections, poorly controlled high blood pressure, type I diabetes, urinary incontinence, etc.
- Abnormal laboratory tests, such as a) Alanine transaminase (ALT)/Aspartate aminotransferase (AST)>2.0×UNL and/or total bilirubin>1.5×UNL; b) hemoglobin <100 g/L; c) hepatitis B surface antigen positive, hepatitis C antibody positive, HIV antibody positive , Syphilis antibody positive.
- The researcher believes that the subject has any situation that may interfere with the interpretation of the pharmacokinetics, efficacy and safety data of this study.
- Subjects considered by the researcher to be unsuitable to participate in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of the Pharmacokinetics/Pharmacodynamics and Safety of Rongliflozin in Chinese Subjects With Type 2 Diabetes With Normal Renal Function and Mild to Moderate Renal Impairment
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
- Conditions
- Type 2 Diabetes
- Being tested
- pyroglutamate rongliflozin capsules
- 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.
pyroglutamate rongliflozin capsulesDrug
Subjects will receive one 50mg capsule orally (by mouth) on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Group A and C (normal kidney function) | Active comparator | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
| Group B (mild renal impairment) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
| Group D (moderate renal impairment) | Experimental | Each subject will receive a single dose of rongliflozin on Day 1 Receives: Drug: pyroglutamate rongliflozin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of rongliflozin
Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function.
Measured: 0 hour（pre-dose） to 96 hours after administration
Secondary outcomes (1)
Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function
Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of rongliflozin will be used to evaluate the pharmacodynamics of rongliflozin (ie, how the drug affects the body) in varying degrees of kidney function.
Measured: Day -1 (Baseline) to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start5 May 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Sunshine Lake Pharma 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ping Feng, Doctor, Principal investigator, West China HospitalZhenmei An, Master, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374343
- Sponsor's protocol ID
- DJT1116PG-DM-106
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Pharmacokinetics/Pharmacodynamics and Safety of Rongliflozin in Chinese Subjects With Type 2 Diabetes With Normal Renal Function and Mild to Moderate Renal Impairment
- ClinicalTrials.gov ID
- NCT05374343
- Acronym / sponsor ID
- DJT1116PG-DM-106
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sunshine Lake Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 16 May 2022 (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.
To evaluate the pharmacokinetic characteristics of pyroglutamate rongliflozin capsules in type 2 diabetic subjects with normal renal function and mild to moderate renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A and C (normal kidney function) | Active comparator | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
| Group B (mild renal impairment) | Experimental | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
| Group D (moderate renal impairment) | Experimental | Drug: pyroglutamate rongliflozin capsulesEach subject will receive a single dose of rongliflozin on Day 1 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes patients.
- The subject is willing to take effective contraceptive measures without a pregnancy plan within 4 weeks after signing the informed consent form to taking the test drug.
- When screening, 19.0 kg/m2 < or = body mass index (BMI) < or = 35.0 kg/m2.
- No hypoglycemic drugs have been used in the 4 weeks before the baseline period, or stable doses of hypoglycemic drugs are being used.
- No medications for other comorbidities or stable medication regimens within 4 weeks before the baseline period.
Key exclusion criteria (14 listed)
- Known allergy to sodium-glucose cotransporter 2 (SGLT2) inhibitor drugs or related excipients.
- In the 3 months before screening, those who smoked more than 5 cigarettes per day on average or who could not give up smoking from signing informed consent to leaving the group.
- Have a history of alcoholism.
- Ingested any food or drink containing caffeine, xanthine, alcohol, grapefruit within 48 hours before taking the test drug.
- Those who donate blood or lose a lot of blood (>400 mL) within 3 months before taking the test drug, or have a history of blood transfusion within 1 month before screening, or plan to donate blood within 1 month after the end of the trial.
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 |
|---|---|---|
| pyroglutamate rongliflozin capsulesSubjects will receive one 50mg capsule orally (by mouth) on Day 1 | Drug | Group A and C (normal kidney function), Group B (mild renal impairment), Group D (moderate renal impairment) |
Primary outcome
Plasma concentrations of rongliflozin
Time frame: 0 hour（pre-dose） to 96 hours after administration
Plasma concentrations of rongliflizin following the administration of a single dose of rongliflozin, the pharmacokinetic parameters for rongliflozin will be measured in varying degrees of kidney function.
1 secondary outcome
Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function
Time frame: Day -1 (Baseline) to Day 5
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 30 Apr 2026.
- 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.
Ping Feng, Doctor principal investigator
West China Hospital
Zhenmei An, Master principal investigator
West China Hospital
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 pyroglutamate rongliflozin capsules in people with Type 2 Diabetes, run by Sunshine Lake Pharma 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 9 inclusion and 14 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 30 Apr 2026. 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?
Plasma concentrations of rongliflozin (time frame: 0 hour（pre-dose） to 96 hours after administration). 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 30 Apr 2026.