Type 2 Diabetes Mellitus (T2DM)NCT07786571
Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate to Severe Chronic Renal Insufficiency
A study testing Dorzagliatin and Linagliptin in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Renal Insufficiency, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study aims to evaluate whether dorzagliatin can improve glycemic homeostasis in patients with type 2 diabetes mellitus (T2DM) complicated by chronic renal insufficiency, and to compare the efficacy of dorzagliatin with linagliptin in improving glycemic control in patients with T2DM and moderate to severe chronic… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Chronic Renal Insufficiency, Chronic Kidney Disease (Stages 3b-5)
- What is being tested?
- Dorzagliatin and Linagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2026to 1 Jul 2029
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years.
- Diagnosed with type 2 diabetes mellitus according to the 2026 American Diabetes Association (ADA) criteria or the 2024 Chinese Guidelines for the Prevention and Treatment of Diabetes.
- Diagnosed with chronic renal insufficiency, with eGFR <45 mL/min/1.73 m² calculated using the Modification of Diet in Renal Disease (MDRD) equation, and not receiving maintenance dialysis.
- HbA1c between 7.0% and 9.0%.
- Receiving a stable antihyperglycemic treatment regimen for at least 4 weeks prior to enrollment. The regimen should include basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are limited to metformin, SGLT2 inhibitors, alpha-glucosidase inhibitors, meglitinides, and TZDs.
- Written informed consent provided.
Who cannot join
- Type 1 diabetes mellitus, latent autoimmune diabetes in adults (LADA), or other specific types of diabetes.
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past 3 months.
- Active liver disease (ALT/AST >3 × ULN) or liver cirrhosis (Child-Pugh class B or above).
- Severe heart failure (NYHA class III-IV) or a history of acute coronary syndrome or stroke within the past 6 months.
- Malignancy or life expectancy <6 months.
- Pregnant or lactating women, or women of childbearing potential not using effective contraception.
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- Known allergy to dorzagliatin or any of its components.
- Known allergy to linagliptin or any of its components.
- Current participation in another interventional clinical trial.
- Mental illness or cognitive impairment preventing compliance with study follow-up.
- Severe gastrointestinal disease affecting drug absorption.
- Current use of strong CYP3A4 inducers (e.g., rifampicin) or inhibitors (e.g., ketoconazole) that cannot be discontinued.
- Severe hypertriglyceridemia (>5.7 mmol/L).
- Dialysis for acute renal failure within 3 months before run-in, current dialysis, or need for/planned kidney transplantation within 12 months.
- Use of corticosteroids or immunosuppressants within the past 6 months.
- Current use of incretin-based therapies.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: A Prospective, Randomized, Active-Controlled, Multicenter Clinical Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate to Severe Chronic Renal Insufficiency
This study aims to evaluate whether dorzagliatin can improve glycemic homeostasis in patients with type 2 diabetes mellitus (T2DM) complicated by chronic renal insufficiency, and to compare the efficacy of dorzagliatin with linagliptin in improving glycemic control in patients with T2DM and moderate to severe chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m²).
This is a prospective, randomized, active-controlled, multicenter clinical study planned to enroll 206 eligible patients. After successful screening, patients will enter a 2-week run-in period consisting of diet and exercise control together with continuous glucose monitoring (CGM). Eligible patients will then be randomized to receive dorzagliatin 75 mg twice daily (BID) or linagliptin 5 mg once daily (QD) on top of background antihyperglycemic therapy. Basal insulin therapy will be standardized to insulin glargine U300 after treatment initiation. The treatment period will last 14 weeks, followed by a 1-week safety follow-up period.
Read the detailed description
This is a prospective, randomized, active-controlled, multicenter clinical study designed to enroll 206 eligible patients with T2DM complicated by moderate to severe chronic renal insufficiency.
Patients who pass screening will first enter a 2-week run-in period involving diet and exercise control and continuous glucose monitoring (CGM). Laboratory assessments and other relevant evaluations will be performed within 3 days prior to randomization.
At the randomization visit, eligibility will be reconfirmed according to the inclusion and exclusion criteria. Qualified patients will then be randomly assigned through a random number system to receive either dorzagliatin tablets 75 mg BID or linagliptin tablets 5 mg QD.
Both groups will receive study treatment on the basis of background antihyperglycemic therapy. Background antihyperglycemic therapy is defined as a stable glucose-lowering regimen used for at least 4 weeks prior to enrollment, consisting of basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are restricted to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors (AGIs), meglitinides, and thiazolidinediones (TZDs). After treatment initiation, basal insulin will be standardized to insulin glargine U300 in all patients.
The treatment duration is 14 weeks. At the end of treatment, investigational medication will be discontinued, followed by a 1-week safety follow-up period.
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Chronic Renal Insufficiency, Chronic Kidney Disease (Stages 3b-5), Glucose Homeostasis
- Being tested
- Dorzagliatin, Linagliptin
- Keywords
- Dorzagliatin, Linagliptin, Time in Range, Glycemic Homeostasis
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DorzagliatinDrug
insulin glargine U300 with 0-2 OAD
LinagliptinDrug
insulin glargine U300 with 0-2 OAD
| Study group | Role | What they receive |
|---|---|---|
| Dorzagliatin Group | Experimental | Dorzagliatin tablets, 75 mg BID Receives: Drug: Dorzagliatin |
| Linagliptin Group | Active comparator | Linagliptin tablets, 5 mg QD Receives: Drug: Linagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Time in Range (TIR, 3.9-10.0 mmol/L) from baseline to Week 14
To compare the change in TIR (3.9-10.0 mmol/L) from baseline to Week 14 between the dorzagliatin 75 mg BID group and the linagliptin 5 mg QD group in patients with T2DM complicated by moderate to severe chronic renal insufficiency.
Measured: Baseline to Week 14
Secondary outcomes (1)
Change in HbA1c from baseline to Week 14
Measured: Baseline to Week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Why it stopped: The study was withdrawn because the protocol was revised and would be replaced by an updated study design, prior to participant enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanbing Li, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yanbing Li, Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786571
- Sponsor's protocol ID
- IIT-2026-766
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Active-Controlled, Multicenter Clinical Study on Improving Blood Glucose Homeostasis With Dorzagliatin Tablets in the Treatment of Type 2 Diabetes Mellitus Patients With Moderate to Severe Chronic Renal Insufficiency
- ClinicalTrials.gov ID
- NCT07786571
- Acronym / sponsor ID
- IIT-2026-766
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Chronic Renal Insufficiency, Chronic Kidney Disease (Stages 3b-5), Glucose Homeostasis
- Keywords
- Dorzagliatin, Linagliptin, Time in Range, Glycemic Homeostasis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was withdrawn because the protocol was revised and would be replaced by an updated study design, prior to participant enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 26 Aug 2026 (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 study aims to evaluate whether dorzagliatin can improve glycemic homeostasis in patients with type 2 diabetes mellitus (T2DM) complicated by chronic renal insufficiency, and to compare the efficacy of dorzagliatin with linagliptin in improving glycemic control in patients with T2DM and moderate to severe chronic renal insufficiency (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m²).
This is a prospective, randomized, active-controlled, multicenter clinical study planned to enroll 206 eligible patients. After successful screening, patients will enter a 2-week run-in period consisting of diet and exercise control together with continuous glucose monitoring (CGM). Eligible patients will then be randomized to receive dorzagliatin 75 mg twice daily (BID) or linagliptin 5 mg once daily (QD) on top of background antihyperglycemic therapy. Basal insulin therapy will be standardized to insulin glargine U300 after treatment initiation. The treatment period will last 14 weeks, followed by a 1-week safety follow-up period.
Detailed description
This is a prospective, randomized, active-controlled, multicenter clinical study designed to enroll 206 eligible patients with T2DM complicated by moderate to severe chronic renal insufficiency.
Patients who pass screening will first enter a 2-week run-in period involving diet and exercise control and continuous glucose monitoring (CGM). Laboratory assessments and other relevant evaluations will be performed within 3 days prior to randomization.
At the randomization visit, eligibility will be reconfirmed according to the inclusion and exclusion criteria. Qualified patients will then be randomly assigned through a random number system to receive either dorzagliatin tablets 75 mg BID or linagliptin tablets 5 mg QD.
Both groups will receive study treatment on the basis of background antihyperglycemic therapy. Background antihyperglycemic therapy is defined as a stable glucose-lowering regimen used for at least 4 weeks prior to enrollment, consisting of basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are restricted to metformin, sodium-glucose cotransporter-2 (SGLT2) inhibitors, alpha-glucosidase inhibitors (AGIs), meglitinides, and thiazolidinediones (TZDs). After treatment initiation, basal insulin will be standardized to insulin glargine U300 in all patients.
The treatment duration is 14 weeks. At the end of treatment, investigational medication will be discontinued, followed by a 1-week safety follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dorzagliatin Group | Experimental | Drug: DorzagliatinDorzagliatin tablets, 75 mg BID |
| Linagliptin Group | Active comparator | Drug: LinagliptinLinagliptin tablets, 5 mg QD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 to 80 years.
- Diagnosed with type 2 diabetes mellitus according to the 2026 American Diabetes Association (ADA) criteria or the 2024 Chinese Guidelines for the Prevention and Treatment of Diabetes.
- Diagnosed with chronic renal insufficiency, with eGFR <45 mL/min/1.73 m² calculated using the Modification of Diet in Renal Disease (MDRD) equation, and not receiving maintenance dialysis.
- HbA1c between 7.0% and 9.0%.
- Receiving a stable antihyperglycemic treatment regimen for at least 4 weeks prior to enrollment. The regimen should include basal insulin injection (excluding insulin-incretin combination preparations) and 0 to 2 oral antidiabetic drugs. Oral antidiabetic drugs are limited to metformin, SGLT2 inhibitors, alpha-glucosidase inhibitors, meglitinides, and TZDs.
Key exclusion criteria (16 listed)
- Type 1 diabetes mellitus, latent autoimmune diabetes in adults (LADA), or other specific types of diabetes.
- Diabetic ketoacidosis or hyperosmolar hyperglycemic state within the past 3 months.
- Active liver disease (ALT/AST >3 × ULN) or liver cirrhosis (Child-Pugh class B or above).
- Severe heart failure (NYHA class III-IV) or a history of acute coronary syndrome or stroke within the past 6 months.
- Malignancy or life expectancy <6 months.
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 |
|---|---|---|
| Dorzagliatininsulin glargine U300 with 0-2 OAD | Drug | Dorzagliatin Group |
| Linagliptininsulin glargine U300 with 0-2 OAD | Drug | Linagliptin Group |
Primary outcome
Change in Time in Range (TIR, 3.9-10.0 mmol/L) from baseline to Week 14
Time frame: Baseline to Week 14
To compare the change in TIR (3.9-10.0 mmol/L) from baseline to Week 14 between the dorzagliatin 75 mg BID group and the linagliptin 5 mg QD group in patients with T2DM complicated by moderate to severe chronic renal insufficiency.
1 secondary outcome
Change in HbA1c from baseline to Week 14
Time frame: Baseline to Week 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 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.
Yanbing Li principal investigator
First Affiliated Hospital, Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dorzagliatin and Linagliptin in people with Type 2 Diabetes Mellitus (T2DM) and Chronic Renal Insufficiency, run by Sun Yat-sen University 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 16 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: withdrawn, as of the sponsor's last update on 16 Oct 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Time in Range (TIR, 3.9-10.0 mmol/L) from baseline to Week 14 (time frame: Baseline to Week 14). 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 16 Oct 2026.