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NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor.
The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.
A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study assessing a 12-week period of treatment with oral GKT137831 administered in addition to standard of care for patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GKT137831 | Experimental | GKT137831 100 mg capsules twice a day |
|
| Placebo | Placebo Comparator | Placebo capsule twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GKT137831 | Drug | 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group | UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11). | Visit 4 (week -2) to visit 11 (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Metabolism by Homeostatic Model Assessment (HOMA) | Change in homeostasis model assessment-estimated β cell function (HOMA-B) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) from baseline. HOMA-IR = fasting insulin (μIU/mL) x fasting glucose (mM/L)/22.5. A higher HOMA-IR value indicates greater insulin resistance. HOMA-B = 20 x fasting insulin (μIU/mL)/(fasting glucose [mmol/mL] - 3.5). Generally, a higher HOMA-B value indicates better beta-cell function, meaning the pancreas is producing insulin effectively. |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile Dysfunction | Changes at week 12 in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline (Baseline <=25 in the erectile function domain)- Score from 1 to 30. Score 1 to 10: severe erectile dysfunction, Score 11-16: moderate erectile dysfunction, Score 17-25: light erectile dysfunction, Score 26-30: normal erectile function | Visits 5 (week 0), and 11 (week 12) |
Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe Wiesel, MD | Calliditas Therapeutics AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Arizona Clinical Research | Tucson | Arizona | 85712 | United States | ||
| The Endocrine Medical Group, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41805697 | Derived | Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GKT137831 | GKT137831 100 mg capsules twice a day GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment. |
|
| Visits 5 (week 0), 8 (week 6), and 11 (week 12) |
| Glucose Metabolism HbA1c | Change in HbA1c from Baseline | Visit 5 (week 0), 8 (week 6) and 11 (week 12) |
| 24 Hours Albumin Excretion | Change in 24 hours Albumin excretion from baseline | Visits 5 (week 0) and 11 (week 12) |
| 24 Hours Urine UACR | Change in 24 hours Urine UACR from baseline | Visits 5 (week 0) and 11 (week 12) |
| eGFR Change by Study Visit | Change in eGFR from baseline by study visit | Visits 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), follow up (week 16) |
| Neuropathic Pain | Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline (subjects with a baseline VAS>=20mm are included). A 100mm VAS scale was used with a range from 0-100mm where a higher score means worse pain. The presence of neuropathic pain is defined a VAS score of at least 20 mm. | Visits 5 (week 0), and 11 (week 12) |
| Orange |
| California |
| 92868 |
| United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| The Center for Diabetes and Endocrine Care | Hollywood | Florida | 33021 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 33216 | United States |
| Genoma Research Group, Inc. | Miami | Florida | 33165 | United States |
| Coral Research Clinic | Miami | Florida | 33175 | United States |
| Pines Clinical Research Inc. | Pembroke Pines | Florida | 33028 | United States |
| Volunteer Medical Research | Port Charlotte | Florida | 33952 | United States |
| John H. Stroger Jr. Hospital of Cook County | Chicago | Illinois | 60612 | United States |
| Community Medical Research Partners | Indianapolis | Indiana | 46234 | United States |
| Kansas City VA Medical Center | Kansas City | Missouri | 64128 | United States |
| Creighton Diabetes Center | Omaha | Nebraska | 68114 | United States |
| LLC DBA AccessMD Clinical Research | Dayton | Ohio | 45424 | United States |
| Southeast Renal Research Institute | Chattanooga | Tennessee | 37408 | United States |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75201 | United States |
| 17070 Red Oak dr Ste 103 | Houston | Texas | 77090 | United States |
| Dialysis West University Health System | San Antonio | Texas | 78229 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Zablocki VAMC | Milwaukee | Wisconsin | 53095 | United States |
| Royal Prince Alfred Hospital | Camperdown | New South Wales | 2050 | Australia |
| Deakin University school of medicine | Geelong | Victoria | 3220 | Australia |
| Austin Health | Heidelberg | Victoria | 3081 | Australia |
| Baker Institute | Melbourne | Victoria | 3004 | Australia |
| Maroondah ECRU | Ringwood East | Victoria | 3135 | Australia |
| Captain Stirling Medical Centre | Nedlands | Western Australia | 6009 | Australia |
| Endocrine Research Inc. | Vancouver | British Columbia | V6E1M7 | Canada |
| LMC Diabetes & Endocrinology | Brampton | Ontario | L6S 0C9 | Canada |
| Clinical Research Solutions | Kitchener | Ontario | N2H 5Z8 | Canada |
| LMC Diabetes and Endocrinology | Thornhill | Ontario | L4J8L7 | Canada |
| Toronto East General Medical Centre | Toronto | Ontario | M4C 5T2 | Canada |
| Medpharmgene | Montreal | Quebec | H1Y 3L1 | Canada |
| Nemocnice Havlickuv Brod | Huzová | 2624 | Czechia |
| Oblastni nemocnice Jicin a.s. | Nový Bydžov | Czechia |
| Faculty Hospital and Palacky University Olomouc | Olomouc | Czechia |
| Milan Kvapil s.r.o. diabetology ambulance | Prague | 14900 | Czechia |
| IKEM | Prague | 4021 | Czechia |
| Studienzentrum Haematologie/Onkologie/Diabeteologie | Aschaffenburg | 63739 | Germany |
| ZKS Suedbrandenburg GmbH | Elsterwerda | 4906 | Germany |
| IKFE - Institute for Clinical Research and Development | Mainz | 55116 | Germany |
| IDFM | München | 48155 | Germany |
| Centrum Badaa Klinicznych PI-House Sp. z o.o. | Gdansk | 80-546 | Poland |
| LANDA Specjalistyczne Gabinety Lekarskie | Krakow | 30-015 | Poland |
| Medicus w Opolu sp z o.o. | Opole | 45367 | Poland |
| Praktyka Lekarska Ewa Krzyzagorska | Poznan | 61-655 | Poland |
| KO-MED Centra Kliniczne Sp. z o.o. | Staszów | 28200 | Poland |
| Department of Nephrology, Transplantationa and Internal Medicine | Szczecin | 70-711 | Poland |
| Medica Pro Familia Sp. z o.o. S.K.A. | Warsaw | 01-868 | Poland |
Placebo capsule twice a day
Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GKT137831 | GKT137831 100 mg capsules twice a day GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment |
| BG001 | Placebo | Placebo capsule twice a day Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group | UACR from baseline to Visits 9, 10, and 11 (i.e. weeks 8, 10 and 12 of the treatment period, respectively). Baseline for UACR is defined as the geometric mean of the geometric means of the UACR values measured on Day-14 (visit 4) and Day 1 (visit 5). End of treatment is defined as the geometric mean of the geometric means of the UACR values measured at week 8 (visit 9), week 10 (visit 10) and week 12 (visit 11). | Number of subjects analyzed in the Intent to Treat population who have evaluable results | Posted | Geometric Mean | 90% Confidence Interval | mg/g | Visit 4 (week -2) to visit 11 (week 12) |
|
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glucose Metabolism by Homeostatic Model Assessment (HOMA) | Change in homeostasis model assessment-estimated β cell function (HOMA-B) and homeostasis model assessment-estimated insulin resistance (HOMA-IR) from baseline. HOMA-IR = fasting insulin (μIU/mL) x fasting glucose (mM/L)/22.5. A higher HOMA-IR value indicates greater insulin resistance. HOMA-B = 20 x fasting insulin (μIU/mL)/(fasting glucose [mmol/mL] - 3.5). Generally, a higher HOMA-B value indicates better beta-cell function, meaning the pancreas is producing insulin effectively. | Number of subjects analyzed in the Intent to treat population who have evaluable results | Posted | Mean | Standard Deviation | score on a scale | Visits 5 (week 0), 8 (week 6), and 11 (week 12) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Glucose Metabolism HbA1c | Change in HbA1c from Baseline | Number of subjects in the Intend to Treat Population who have evaluable results | Posted | Mean | Standard Deviation | percentage of glycated haemoglobin | Visit 5 (week 0), 8 (week 6) and 11 (week 12) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 24 Hours Albumin Excretion | Change in 24 hours Albumin excretion from baseline | Number of subjects analyzed in the intent to treat population who have evaluable results | Posted | Mean | Standard Deviation | mg/24hrs | Visits 5 (week 0) and 11 (week 12) |
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| Secondary | 24 Hours Urine UACR | Change in 24 hours Urine UACR from baseline | Number of subjects analyzed in the intent to treat population who have evaluable results | Posted | Mean | Standard Deviation | mg/g | Visits 5 (week 0) and 11 (week 12) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | eGFR Change by Study Visit | Change in eGFR from baseline by study visit | Number of subjects analyzed in the intent to treat Population who have evaluable results | Posted | Mean | Standard Deviation | mL/min/1.73m^2 | Visits 5 (week 0), 6 (week 2), 7 (week 4), 8 (week 6), 9 (week 8), 10 (week 10), 11 (week 12), follow up (week 16) |
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| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Erectile Dysfunction | Changes at week 12 in IEFF questionnaire assessing erectile dysfunction in patients presenting with these diabetic complications at baseline (Baseline <=25 in the erectile function domain)- Score from 1 to 30. Score 1 to 10: severe erectile dysfunction, Score 11-16: moderate erectile dysfunction, Score 17-25: light erectile dysfunction, Score 26-30: normal erectile function | Number of subjects analyzed in the Intent to Treat population who have evaluable results | Posted | Mean | Standard Deviation | score on a scale | Visits 5 (week 0), and 11 (week 12) |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Neuropathic Pain | Changes in Visual Analog Scale (VAS) assessing neuropathic leg pain in patients presenting with these diabetic complications at baseline (subjects with a baseline VAS>=20mm are included). A 100mm VAS scale was used with a range from 0-100mm where a higher score means worse pain. The presence of neuropathic pain is defined a VAS score of at least 20 mm. | Number of subjects analyzed in the Intent to treat population who have evaluable results | Posted | Mean | Standard Deviation | score on a scale | Visits 5 (week 0), and 11 (week 12) |
|
|
Approximately 9-10 months
Adverse events were collected after signing the informed consent form (ICF) and up to completion of the 30-day follow-up period after the last administration of IMP
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GKT137831 | GKT137831 100 mg capsules twice a day GKT137831: 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment | 0 | 68 | 3 | 68 | 33 | 68 |
| EG001 | Placebo | Placebo capsule twice a day Placebo: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment. | 0 | 68 | 5 | 68 | 42 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Lobular Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary Tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Small Cell Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypoglycemic encephalopathy | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Urinary Tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anthralgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Edema peripheral | General disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Blood Thyroid Stimulating Hormone increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Respiratory, thoracic disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
| |
| Renal and urinary disorders | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Philipson, MD Chief Medical Officer | Calliditas Therapeutics | +46 556659-9766 | richard.philipson@calliditas.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011507 | Proteinuria |
| D000419 | Albuminuria |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C576694 | setanaxib |
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| >=65 years |
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| Male |
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| United States |
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| Czechia |
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| Poland |
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| Australia |
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| Germany |
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| Participants |
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