Type 2 Diabetes Mellitus With Diabetic NephropathyPhase 2NCT02010242
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
A Phase 2 study testing GKT137831 in people with Type 2 Diabetes Mellitus With Diabetic Nephropathy, run by Calliditas Therapeutics AB at 48 sites in 6 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus With Diabetic Nephropathy
- What is being tested?
- GKT137831
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 48 sitesin 6 countries
- Study dates
- Oct 2013to Mar 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female aged 18 to 80 years
- History of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/L (126 mg/dL) or a glycated hemoglobin (HbA1c) >6.5% (48 mmol/mol) on at least 2 occasions prior to screening.
- Albuminuria defined as a UACR of 300 to 3500 mg/g.
- An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
- Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted.
Who cannot join
- History of type 1 diabetes
- Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
- History of renal transplant or planned renal transplant during the study.
- A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes [KDIGO] definition) within 12 weeks of the first screening visit (Visit 1)
- HbA1c level >11% (97 mmol/mol).
Show all 10Show fewer
- History of hypothyroidism requiring hormone replacement therapy.
- History of active cardiovascular disease
- A personal or family history of long QT syndrome.
- Administration of any investigational product within 30 days or within 5 half-lives of the investigational agent
Trial locations and contacts
48 sites in 6 countries.
48 sites in 6 countries
United States20 sites
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
John H. Stroger Jr. Hospital of Cook County
Chicago, Illinois, 60612
Clinical Research of South Florida
Coral Gables, Florida, 33134
The University of Texas Southwestern Medical Center
Dallas, Texas, 75201
LLC DBA AccessMD Clinical Research
Dayton, Ohio, 45424
The Center for Diabetes and Endocrine Care
Hollywood, Florida, 33021
17070 Red Oak dr Ste 103
Houston, Texas, 77090
Community Medical Research Partners
Indianapolis, Indiana, 46234
Jacksonville Center for Clinical Research
Jacksonville, Florida, 33216
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Genoma Research Group, Inc.
Miami, Florida, 33165
Coral Research Clinic
Miami, Florida, 33175
Zablocki VAMC
Milwaukee, Wisconsin, 53095
Creighton Diabetes Center
Omaha, Nebraska, 68114
The Endocrine Medical Group, Inc
Orange, California, 92868
Pines Clinical Research Inc.
Pembroke Pines, Florida, 33028
Volunteer Medical Research
Port Charlotte, Florida, 33952
McGuire VA Medical Center
Richmond, Virginia, 23249
Dialysis West University Health System
San Antonio, Texas, 78229
Advanced Arizona Clinical Research
Tucson, Arizona, 85712
Poland7 sites
Centrum Badaa Klinicznych PI-House Sp. z o.o.
Gdansk, 80-546
LANDA Specjalistyczne Gabinety Lekarskie
Krakow, 30-015
Medicus w Opolu sp z o.o.
Opole, 45367
Praktyka Lekarska Ewa Krzyzagorska
Poznan, 61-655
KO-MED Centra Kliniczne Sp. z o.o.
Staszów, 28200
Department of Nephrology, Transplantationa and Internal Medicine
Szczecin, 70-711
Medica Pro Familia Sp. z o.o. S.K.A.
Warsaw, 01-868
Australia6 sites
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Deakin University school of medicine
Geelong, Victoria, 3220
Austin Health
Heidelberg, Victoria, 3081
Baker Institute
Melbourne, Victoria, 3004
Captain Stirling Medical Centre
Nedlands, Western Australia, 6009
Maroondah ECRU
Ringwood East, Victoria, 3135
Canada6 sites
LMC Diabetes & Endocrinology
Brampton, Ontario, L6S 0C9
Clinical Research Solutions
Kitchener, Ontario, N2H 5Z8
Medpharmgene
Montreal, Quebec, H1Y 3L1
LMC Diabetes and Endocrinology
Thornhill, Ontario, L4J8L7
Toronto East General Medical Centre
Toronto, Ontario, M4C 5T2
Endocrine Research Inc.
Vancouver, British Columbia, V6E1M7
Czechia5 sites
Nemocnice Havlickuv Brod
Huzová, 2624
Oblastni nemocnice Jicin a.s.
Nový Bydžov
Faculty Hospital and Palacky University Olomouc
Olomouc
Milan Kvapil s.r.o. diabetology ambulance
Prague, 14900
IKEM
Prague, 4021
Germany4 sites
Studienzentrum Haematologie/Onkologie/Diabeteologie
Aschaffenburg, 63739
ZKS Suedbrandenburg GmbH
Elsterwerda, 4906
IKFE - Institute for Clinical Research and Development
Mainz, 55116
IDFM
München, 48155
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients With Type 2 Diabetes and Albuminuria
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.
Read the detailed description
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.
- Being tested
- GKT137831, Placebo
- Keywords
- Type 2 diabetes, Proteinuria, Albuminuria
- Medical subject headings
- Diabetes Mellitus, Type 2, Proteinuria, Albuminuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKT137831Drug
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
PlaceboDrug
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| GKT137831 | Experimental | GKT137831 100 mg capsules twice a day Receives: Drug: GKT137831 |
| Placebo | Placebo comparator | Placebo capsule twice a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Visit 4 (week -2) to visit 11 (week 12)
Secondary outcomes (5)
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.
Measured: Visits 5 (week 0), 8 (week 6), and 11 (week 12)
Glucose Metabolism HbA1c
Change in HbA1c from Baseline
Measured: Visit 5 (week 0), 8 (week 6) and 11 (week 12)
24 Hours Albumin Excretion
Change in 24 hours Albumin excretion from baseline
Measured: Visits 5 (week 0) and 11 (week 12)
24 Hours Urine UACR
Change in 24 hours Urine UACR from baseline
Measured: Visits 5 (week 0) and 11 (week 12)
eGFR Change by Study Visit
Change in eGFR from baseline by study visit
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus With Diabetic NephropathyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Calliditas Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Wiesel, MD, Study director, Calliditas Therapeutics AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010242
- Sponsor's protocol ID
- GSN000200
- Status last verified
- Feb 2025
- First submitted
- 18 Jun 2013
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 41805697
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients With Type 2 Diabetes and Albuminuria
- ClinicalTrials.gov ID
- NCT02010242
- Acronym / sponsor ID
- GSN000200
- Keywords
- Type 2 diabetes, Proteinuria, Albuminuria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Calliditas Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GKT137831 | Experimental | Drug: GKT137831GKT137831 100 mg capsules twice a day |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule twice a day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female aged 18 to 80 years
- History of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/L (126 mg/dL) or a glycated hemoglobin (HbA1c) >6.5% (48 mmol/mol) on at least 2 occasions prior to screening.
- Albuminuria defined as a UACR of 300 to 3500 mg/g.
- An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
- Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted.
Key exclusion criteria (10 listed)
- History of type 1 diabetes
- Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
- Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
- History of renal transplant or planned renal transplant during the study.
- A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes [KDIGO] definition) within 12 weeks of the first screening visit (Visit 1)
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 |
|---|---|---|
| GKT1378311 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 | Drug | GKT137831 |
| Placebo1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment. | Drug | Placebo |
Primary outcome
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group
Time frame: Visit 4 (week -2) to visit 11 (week 12)
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).
5 secondary outcomes
Glucose Metabolism by Homeostatic Model Assessment (HOMA)
Time frame: Visits 5 (week 0), 8 (week 6), and 11 (week 12)
Glucose Metabolism HbA1c
Time frame: Visit 5 (week 0), 8 (week 6) and 11 (week 12)
24 Hours Albumin Excretion
Time frame: Visits 5 (week 0) and 11 (week 12)
24 Hours Urine UACR
Time frame: Visits 5 (week 0) and 11 (week 12)
eGFR Change by Study Visit
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41805697Hu 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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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.
Philippe Wiesel, MD study director
Calliditas Therapeutics AB
48 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GKT137831 in people with Type 2 Diabetes Mellitus With Diabetic Nephropathy, run by Calliditas Therapeutics AB at 48 sites in 6 countries.
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 5 inclusion and 10 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 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Poland, Australia, Canada, Czechia and 1 more country. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group (time frame: Visit 4 (week -2) to visit 11 (week 12)). 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 NCT02010242, 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 28 Feb 2025.