Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE1
Total Enrollment
20 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-10-31
Study Completion Date
2025-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The goal of this clinical trial is to learn PK and PD of YG1699 in patients with diabetes and renal dysfuction.
Participants will:
Take YG1699 or a placebo every day for 8 days. Visit the clinic 7 times for checkups and tests. Keep a diary of their symptoms. Estimate PK data from a single dose of YG1699. Estimate PD data at baseline and the last day.
Participants will:
Take YG1699 or a placebo every day for 8 days. Visit the clinic 7 times for checkups and tests. Keep a diary of their symptoms. Estimate PK data from a single dose of YG1699. Estimate PD data at baseline and the last day.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Clinical Trial to Evaluate the Pharmacokinetic Profiles and Safety of CKD-383.
NCT04810676
Type2 Diabetes Mellitus
COMPLETED
PHASE1
Evaluate the Glycemic Control of CKD-501 in Type 2 Diabetes Mellitus
NCT01030679
Diabetes Mellitus, Type 2
COMPLETED
PHASE2
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-387 Under Fed Condition
NCT03738449
Type 2 Diabetes Mellitus
COMPLETED
PHASE1
Type 2 Diabetes Patients With Renal Impairment
NCT04221399
Type2 Diabetes
UNKNOWN
PHASE1
A Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-396
NCT04246190
Type2 Diabetes Mellitus
UNKNOWN
PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background
Diabetic kidney disease (DKD), as one of the most common and serious complications of diabetes, has become the leading cause of end-stage renal disease (ESRD) worldwide. A domestic epidemiological survey shows that the prevalence of DKD in community patients was 30%-50% from 2009 to 2012, and accounted for about 40% in hospitalized patients in China. At present, the treatment of DKD is the comprehensive management of blood glucose, blood pressure and blood lipid. Nevertheless, about one-third of patients with type 1 diabetes mellitus (T1DM) and nearly half of patients with type 2 diabetes mellitus (T2DM) will progress to ESRD. Patients with DKD have higher complication rates and mortality. Studies have shown that the mortality rate of patients with diabetes complicated with DKD is 3 to 12 times higher than that of patients with simple diabetes. Although blood glucose is actively controlled and angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) are used to control hypertension in the treatment of diabetes, the progression of DKD is still inevitable. Much more clinical needs are still present. Sodium-glucose co-transporter inhibitors (SGLT2i) are new hypoglycemic drugs discovered in recent years. They play their hypoglycemic roles by inhibiting glucose reabsorption in renal tubules and increasing urinary glucose excretion. More clinical studies have found that SGLT2s not only the hypoglycemic effect, but also has the effect of delaying the progression of DKD and improving the prognosis of heart failure, and is recommended by international authoritative guidelines with class IA evidence for cardiorenal organ protection.
Glucose cannot freely pass through the cell membrane and must rely on glucose transporter proteins on the cell membrane. Sodium-dependent glucose cotransporters (SGLTs) are an important family of transporter proteins that regulate glucose absorption and excretion. SGLT1 and SGLT2 are the most well studied members of this family and are both major glucose transporter proteins. SGLT1 is expressed in various tissues such as the small intestine, heart and kidney. SGLT2 is mainly expressed in segment S1 of the proximal convoluted tubule of the kidney.
In the renal tubules, 95% of glucose is reabsorbed through SGLT2, and 5% of glucose is reabsorbed through SGLT1. When SGLT2 is inhibited, the glucose reabsorbed through SGLT1 significantly increases to 50%, so the hypoglycemic effect of SGLT2 inhibitors may be weakened. The dual effects of SGLT1 and SGLT2 inhibitors can bring more potential benefits for treatment, including continuing to maintain the effectiveness of SGLT2 selective inhibitors; inducing intestinal cells to secrete endogenous glucagon-like peptide-1 (GLP-1) and YY peptide (PYY); reducing the adverse reactions of SGLT2 inhibition, such as genitourinary tract infections and constipation; blocking or delaying the absorption of glucose by the gastrointestinal tract.
Sotagliflozin is a SGLT2i with partial SGLT1 inhibitory activity. It was approved by the European Medicines Agency (EMA) in 2019 for adjuvant treatment of T1DM complicated with obesity. Recently, the sotagliflozin heart failure protection study was terminated in the middle stage due to the excellent effect of improving the outcome of heart failure. And it has a good effect of reducing proteinuria in patients with DKD. This suggests that SGLT1/2 dual-channel blockers may have better hypoglycemic and organ protection effects.
YG1699 is an oral SGLT1 and SGLT2 dual-channel blocker, belonging to c-aryl glucoside derivatives. It can reduce the absorption of glucose into the blood in the gastrointestinal tract by inhibiting SGLT-1, and at the same time inhibit the reabsorption of glucose in the proximal convoluted tubule of the kidney by inhibiting SGLT-2, thereby increasing the excretion of glucose from the kidney and effectively reducing blood glucose levels. YG1699 reduces the risk of DKA caused by SGLT2i by increasing SGLT1 inhibitory activity. In addition, YG1699 shows non-pH-dependent solubility, has sufficient solubility in the gastrointestinal tract, has a high oral bioavailability in preclinical models, and has a low possibility of drug interactions. At present, including YG1699, there are three SGLT1/2 dual inhibitor are in the clinical research stage.
YG1699 has completed three clinical trials, named the phase I study (YG1699-01) on healthy subjects in the United States and the phase II study (YG1699-201) on type 1 diabetes, as well as the bridging study (YG1699-102) on healthy subjects in China. These clinical studies have confirmed that YG1699 has good human PK characteristics and good safety and tolerance. In the phase II T1DM study, compared head-to-head with DAPA, it shows a better effect on reducing postprandial blood glucose. All these clinical trials are in patients with eGFR\>30 ml/min/1.73M2.
However, about 12 million diabetic patients have renal insufficiency, and there is still no pharmacokinetic and pharmacodynamic data of YG1699 in patients with renal insufficiency.
Key inclusion criteria include:
1. Ability to provide informed consent
2. Male or female patients ,age between 18 and 70 at screening
3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
4. Fasting blood glucose \<11.1 mmol/L, stable on baseline anti-diabetic medication
5. No history of SGLT2i use within the past month
6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
7. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
Key exclusion criteria include:
1. Hypoglycemia occurs more than 2 times in one month
2. History of ketoacidosis
3. Patients who are being treated with swiram and digoxin
4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week) 5. Abnormal liver function (ALT \>3 times the upper limit of normal value)
6\. Hemoglobin \<80g/L or \>150g/L 7. The blood pressure of patients with recent symptomatic hypotension is lower than 90/60 mmHg 8. There is acute myocardial infarction stroke infection in the past month 9. There is systemic active infection or uncured tumor 10. The dialysis regimen of HD patients included HP treatment 11. Participating in other interventional clinical studies 12. Pregnant or lactating women 13. Other situations that the researcher thinks are not suitable for joining the study
Diabetic kidney disease (DKD), as one of the most common and serious complications of diabetes, has become the leading cause of end-stage renal disease (ESRD) worldwide. A domestic epidemiological survey shows that the prevalence of DKD in community patients was 30%-50% from 2009 to 2012, and accounted for about 40% in hospitalized patients in China. At present, the treatment of DKD is the comprehensive management of blood glucose, blood pressure and blood lipid. Nevertheless, about one-third of patients with type 1 diabetes mellitus (T1DM) and nearly half of patients with type 2 diabetes mellitus (T2DM) will progress to ESRD. Patients with DKD have higher complication rates and mortality. Studies have shown that the mortality rate of patients with diabetes complicated with DKD is 3 to 12 times higher than that of patients with simple diabetes. Although blood glucose is actively controlled and angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB) are used to control hypertension in the treatment of diabetes, the progression of DKD is still inevitable. Much more clinical needs are still present. Sodium-glucose co-transporter inhibitors (SGLT2i) are new hypoglycemic drugs discovered in recent years. They play their hypoglycemic roles by inhibiting glucose reabsorption in renal tubules and increasing urinary glucose excretion. More clinical studies have found that SGLT2s not only the hypoglycemic effect, but also has the effect of delaying the progression of DKD and improving the prognosis of heart failure, and is recommended by international authoritative guidelines with class IA evidence for cardiorenal organ protection.
Glucose cannot freely pass through the cell membrane and must rely on glucose transporter proteins on the cell membrane. Sodium-dependent glucose cotransporters (SGLTs) are an important family of transporter proteins that regulate glucose absorption and excretion. SGLT1 and SGLT2 are the most well studied members of this family and are both major glucose transporter proteins. SGLT1 is expressed in various tissues such as the small intestine, heart and kidney. SGLT2 is mainly expressed in segment S1 of the proximal convoluted tubule of the kidney.
In the renal tubules, 95% of glucose is reabsorbed through SGLT2, and 5% of glucose is reabsorbed through SGLT1. When SGLT2 is inhibited, the glucose reabsorbed through SGLT1 significantly increases to 50%, so the hypoglycemic effect of SGLT2 inhibitors may be weakened. The dual effects of SGLT1 and SGLT2 inhibitors can bring more potential benefits for treatment, including continuing to maintain the effectiveness of SGLT2 selective inhibitors; inducing intestinal cells to secrete endogenous glucagon-like peptide-1 (GLP-1) and YY peptide (PYY); reducing the adverse reactions of SGLT2 inhibition, such as genitourinary tract infections and constipation; blocking or delaying the absorption of glucose by the gastrointestinal tract.
Sotagliflozin is a SGLT2i with partial SGLT1 inhibitory activity. It was approved by the European Medicines Agency (EMA) in 2019 for adjuvant treatment of T1DM complicated with obesity. Recently, the sotagliflozin heart failure protection study was terminated in the middle stage due to the excellent effect of improving the outcome of heart failure. And it has a good effect of reducing proteinuria in patients with DKD. This suggests that SGLT1/2 dual-channel blockers may have better hypoglycemic and organ protection effects.
YG1699 is an oral SGLT1 and SGLT2 dual-channel blocker, belonging to c-aryl glucoside derivatives. It can reduce the absorption of glucose into the blood in the gastrointestinal tract by inhibiting SGLT-1, and at the same time inhibit the reabsorption of glucose in the proximal convoluted tubule of the kidney by inhibiting SGLT-2, thereby increasing the excretion of glucose from the kidney and effectively reducing blood glucose levels. YG1699 reduces the risk of DKA caused by SGLT2i by increasing SGLT1 inhibitory activity. In addition, YG1699 shows non-pH-dependent solubility, has sufficient solubility in the gastrointestinal tract, has a high oral bioavailability in preclinical models, and has a low possibility of drug interactions. At present, including YG1699, there are three SGLT1/2 dual inhibitor are in the clinical research stage.
YG1699 has completed three clinical trials, named the phase I study (YG1699-01) on healthy subjects in the United States and the phase II study (YG1699-201) on type 1 diabetes, as well as the bridging study (YG1699-102) on healthy subjects in China. These clinical studies have confirmed that YG1699 has good human PK characteristics and good safety and tolerance. In the phase II T1DM study, compared head-to-head with DAPA, it shows a better effect on reducing postprandial blood glucose. All these clinical trials are in patients with eGFR\>30 ml/min/1.73M2.
However, about 12 million diabetic patients have renal insufficiency, and there is still no pharmacokinetic and pharmacodynamic data of YG1699 in patients with renal insufficiency.
Key inclusion criteria include:
1. Ability to provide informed consent
2. Male or female patients ,age between 18 and 70 at screening
3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
4. Fasting blood glucose \<11.1 mmol/L, stable on baseline anti-diabetic medication
5. No history of SGLT2i use within the past month
6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
7. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
Key exclusion criteria include:
1. Hypoglycemia occurs more than 2 times in one month
2. History of ketoacidosis
3. Patients who are being treated with swiram and digoxin
4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week) 5. Abnormal liver function (ALT \>3 times the upper limit of normal value)
6\. Hemoglobin \<80g/L or \>150g/L 7. The blood pressure of patients with recent symptomatic hypotension is lower than 90/60 mmHg 8. There is acute myocardial infarction stroke infection in the past month 9. There is systemic active infection or uncured tumor 10. The dialysis regimen of HD patients included HP treatment 11. Participating in other interventional clinical studies 12. Pregnant or lactating women 13. Other situations that the researcher thinks are not suitable for joining the study
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Diabetes
Renal Insufficiency, Chronic
Hemodialysis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
eGFR≥30+YG1699
patients with eGFR ≥30ml/min/1.73M2 will be treated with YG1699 10mg QD for 8 days.
Group Type
EXPERIMENTAL
YG1699
Intervention Type
DRUG
10mg qd for 8 days
Hemodialysis+YG1699
patients on hemodialysis will be treated with YG1699 10mg QD for 8 days.
Group Type
EXPERIMENTAL
YG1699
Intervention Type
DRUG
10mg qd for 8 days
eGFR<20+YG1699
patients with eGFR \<20ml/min/1.73M2 will be treated with YG1699 10mg QD for 8 days.
Group Type
EXPERIMENTAL
YG1699
Intervention Type
DRUG
10mg qd for 8 days
eGFR<20+placebo
patients with eGFR \<20ml/min/1.73M2 will be treated with placebo 10mg QD for 8 days.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
10mg qd for 8 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
YG1699
10mg qd for 8 days
Intervention Type
DRUG
Placebo
10mg qd for 8 days
Intervention Type
DRUG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
1. Ability to provide informed consent
2. Male or female patients ,age between 18 and 70 at screening
3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
4. Fasting blood glucose \<11.1 mmol/L, stable on baseline anti-diabetic medication
5. No history of SGLT2i use within the past month
6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
7. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
2. Male or female patients ,age between 18 and 70 at screening
3. Meet the diagnostic criteria for diabetic nephropathy, including patients with type 1 or type 2 diabetes;
4. Fasting blood glucose \<11.1 mmol/L, stable on baseline anti-diabetic medication
5. No history of SGLT2i use within the past month
6. Hemodialysis patients must have maintenance hemodialysis for more than 3 months, with 3 sessions per week (limited to HD or HDF treatment), and spKt/V\>1.2 within 6 months
7. The patient has not used glucocorticoids, calcineurin inhibitors (cyclosporine, tacrolimus), etc. that affect blood sugar within the past month before signing the informed consent form
8. The baseline diabetes management medication regimen has been stable within the past 2 weeks.
Exclusion Criteria
1. Hypoglycemia occurs more than 2 times in one month
2. History of ketoacidosis
3. Patients who are being treated with swiram and digoxin
4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
5. Abnormal liver function (ALT \> 3 times the upper limit of normal value)
6. Hemoglobin \< 80g/L or \> 150g/L
7. The blood pressure of patients with recent symptomatic hypotension is lower than 90/60 mmHg
8. There is acute myocardial infarction stroke infection in the past month
9. There is systemic active infection or uncured tumor
10. The dialysis regimen of HD patients included HP treatment
11. Participating in other interventional clinical studies
12. Pregnant or lactating women
13. Other situations that the researcher thinks are not suitable for joining the study
2. History of ketoacidosis
3. Patients who are being treated with swiram and digoxin
4. Patients with acute kidney injury (serum creatinine increased by ≥ 50% within 1 week)
5. Abnormal liver function (ALT \> 3 times the upper limit of normal value)
6. Hemoglobin \< 80g/L or \> 150g/L
7. The blood pressure of patients with recent symptomatic hypotension is lower than 90/60 mmHg
8. There is acute myocardial infarction stroke infection in the past month
9. There is systemic active infection or uncured tumor
10. The dialysis regimen of HD patients included HP treatment
11. Participating in other interventional clinical studies
12. Pregnant or lactating women
13. Other situations that the researcher thinks are not suitable for joining the study
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RenJi Hospital
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Leyi Gu
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Leyi Gu
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Site Status
Countries
Review the countries where the study has at least one active or historical site.
China
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Wright EM, Loo DD, Hirayama BA. Biology of human sodium glucose transporters. Physiol Rev. 2011 Apr;91(2):733-94. doi: 10.1152/physrev.00055.2009.
Reference Type
BACKGROUND
Powell DR, DaCosta CM, Gay J, Ding ZM, Smith M, Greer J, Doree D, Jeter-Jones S, Mseeh F, Rodriguez LA, Harris A, Buhring L, Platt KA, Vogel P, Brommage R, Shadoan MK, Sands AT, Zambrowicz B. Improved glycemic control in mice lacking Sglt1 and Sglt2. Am J Physiol Endocrinol Metab. 2013 Jan 15;304(2):E117-30. doi: 10.1152/ajpendo.00439.2012. Epub 2012 Nov 13.
Reference Type
BACKGROUND
Abdul-Ghani MA, DeFronzo RA. Inhibition of renal glucose reabsorption: a novel strategy for achieving glucose control in type 2 diabetes mellitus. Endocr Pract. 2008 Sep;14(6):782-90. doi: 10.4158/EP.14.6.782.
Reference Type
BACKGROUND
Rieg T, Masuda T, Gerasimova M, Mayoux E, Platt K, Powell DR, Thomson SC, Koepsell H, Vallon V. Increase in SGLT1-mediated transport explains renal glucose reabsorption during genetic and pharmacological SGLT2 inhibition in euglycemia. Am J Physiol Renal Physiol. 2014 Jan;306(2):F188-93. doi: 10.1152/ajprenal.00518.2013. Epub 2013 Nov 13.
Reference Type
BACKGROUND
Jung CH, Jang JE, Park JY. A Novel Therapeutic Agent for Type 2 Diabetes Mellitus: SGLT2 Inhibitor. Diabetes Metab J. 2014 Aug;38(4):261-73. doi: 10.4093/dmj.2014.38.4.261.
Reference Type
BACKGROUND
Cariou B, Charbonnel B. Sotagliflozin as a potential treatment for type 2 diabetes mellitus. Expert Opin Investig Drugs. 2015;24(12):1647-56. doi: 10.1517/13543784.2015.1100361. Epub 2015 Nov 7.
Reference Type
BACKGROUND
Wang Shanshan, Chen Dong, Chen Mingwei, et al. Analysis of the influence of metabolic syndrome on diabetic nephropathy in patients with type 2 diabetes [J]. Prevention and control of chronic diseases in China, 2011,19 (5):509-511.
Reference Type
BACKGROUND
Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Kottgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20.
Reference Type
RESULT
Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
Reference Type
RESULT
Cherney DZI, Ferrannini E, Umpierrez GE, Peters AL, Rosenstock J, Powell DR, Davies MJ, Banks P, Agarwal R. Efficacy and safety of sotagliflozin in patients with type 2 diabetes and stage 3 chronic kidney disease. Diabetes Obes Metab. 2023 Jun;25(6):1646-1657. doi: 10.1111/dom.15019. Epub 2023 Feb 28.
Reference Type
RESULT
Shanghai Yanjian New Drug R&D Co., Ltd. Handbook for Researchers (Chinese). June 17, 2021
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT-2024-0232
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-386 in Healthy Adult Volunteers
NCT04223895
UNKNOWN
PHASE1
Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
NCT07116928
NOT_YET_RECRUITING
PHASE4
A Study to Test the Effect of Different Doses of BI 685509 on Kidney Function in People With Diabetic Kidney Disease
NCT04750577
COMPLETED
PHASE2
Clinical Study to Compare the Pharmacokinetic Characteristics and Safety Between CKD-380 10mg and D308 10mg
NCT03601910
UNKNOWN
PHASE1
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-375
NCT04221360
UNKNOWN
PHASE1
Clinical Study to Evaluate the Pharmacokinetic Profiles and Safety of CKD-389
NCT04322032
UNKNOWN
PHASE1
Efficacy and Safety of QiShen YiQi Dripping Pills in the Treatment of Diabetic Kidney Disease (Syndrome of Qi Deficiency With Blood Stasis)
NCT06006689
RECRUITING
PHASE2
Evaluate the Efficacy and Safety of DWP16001 in Type 2 Diabetic Nephropathy with Moderate Renal Impairment Patients
NCT06606093
NOT_YET_RECRUITING
PHASE3
Clinical Trial to Investigate the Pharmacokinetics and Safety of CKD-393
NCT04706286
UNKNOWN
PHASE1
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
NCT06666283
RECRUITING
PHASE1
Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy (ARTS-DN Japan)
NCT01968668
COMPLETED
PHASE2
A Clinical Trial to Evaluate the Food Effect of CKD-378
NCT06386328
COMPLETED
PHASE1
To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
NCT01935167
COMPLETED
PHASE2
The Clinical Trial to Investigate the Pharmacokinetics and Safety/Tolerability of CKD-375
NCT03848637
UNKNOWN
PHASE1
Study to Evaluate the Food Effect on Pharmacokinetics Profile and Safety of CKD-393
NCT05274880
COMPLETED
PHASE1
Polyethylene Glycol Loxenatide Pharmacokinetics Study in Subjects With Normal and Insufficiency Renal Function
NCT02467790
UNKNOWN
PHASE1
Study to Evaluate the Pharmacodynamic and Pharmacokinetic Effects of LX4211 in Subjects With Type 2 Diabetes and Renal Impairment
NCT01555008
COMPLETED
PHASE1
Clinical Trial to Evaluate the Drug Drug Interaction of CKD-501 and D308
NCT03616392
COMPLETED
PHASE1
Trial of Pirfenidone to Prevent Progression in Chronic Kidney Disease
NCT04258397
UNKNOWN
PHASE2
The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
NCT02004327
COMPLETED
PHASE1
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
NCT01907113
COMPLETED
PHASE1
Pharmacokinetics, Safety and Tolerability of CKD-387 10/500mg BE Phase1
NCT04156685
COMPLETED
PHASE1
Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes Mellitus and Diabetic Kidney Disease
NCT02540993
COMPLETED
PHASE3
Study to Assess PK, Safety and Tolerability in Patients With DM and CKD
NCT03795389
COMPLETED
PHASE1