Trial · NCT02010242

Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

NCT02010242, Phase 2, Completed, Asahi Kasei Therapeutics, AB; results first posted 2025-02-28

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria. Trials, record NCT02010242. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02010242

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
NCT number: NCT02010242
Status: Completed
Phases: Phase 2
Enrollment: 136 participants, actual
Lead sponsor: Asahi Kasei Therapeutics, AB
Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy
Interventions: GKT137831, Placebo
First posted: 2013-12-12
Last updated: 2025-02-28
Results first posted: 2025-02-28

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group	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).
Secondary	Glucose Metabolism by Homeostatic Model Assessment (HOMA)	Visits 5 (week 0), 8 (week 6), and 11 (week 12)	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.
Secondary	Glucose Metabolism HbA1c	Visit 5 (week 0), 8 (week 6) and 11 (week 12)	Change in HbA1c from Baseline
Secondary	24 Hours Albumin Excretion	Visits 5 (week 0) and 11 (week 12)	Change in 24 hours Albumin excretion from baseline
Secondary	24 Hours Urine UACR	Visits 5 (week 0) and 11 (week 12)	Change in 24 hours Urine UACR from baseline
Secondary	eGFR Change 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)	Change in eGFR from baseline by study visit
Other	Erectile Dysfunction	Visits 5 (week 0), and 11 (week 12)	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
Other	Neuropathic Pain	Visits 5 (week 0), and 11 (week 12)	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group	Visit 4 (week -2) to visit 11 (week 12)	Number of subjects analyzed in the Intent to Treat population who have evaluable results	mg/g	GEOMETRIC_MEAN
SECONDARY	Glucose Metabolism by Homeostatic Model Assessment (HOMA)	Visits 5 (week 0), 8 (week 6), and 11 (week 12)	Number of subjects analyzed in the Intent to treat population who have evaluable results	score on a scale	MEAN
SECONDARY	Glucose Metabolism HbA1c	Visit 5 (week 0), 8 (week 6) and 11 (week 12)	Number of subjects in the Intend to Treat Population who have evaluable results	percentage of glycated haemoglobin	MEAN
SECONDARY	24 Hours Albumin Excretion	Visits 5 (week 0) and 11 (week 12)	Number of subjects analyzed in the intent to treat population who have evaluable results	mg/24hrs	MEAN
SECONDARY	24 Hours Urine UACR	Visits 5 (week 0) and 11 (week 12)	Number of subjects analyzed in the intent to treat population who have evaluable results	mg/g	MEAN
SECONDARY	eGFR Change 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)	Number of subjects analyzed in the intent to treat Population who have evaluable results	mL/min/1.73m^2	MEAN
OTHER_PRE_SPECIFIED	Erectile Dysfunction	Visits 5 (week 0), and 11 (week 12)	Number of subjects analyzed in the Intent to Treat population who have evaluable results	score on a scale	MEAN
OTHER_PRE_SPECIFIED	Neuropathic Pain	Visits 5 (week 0), and 11 (week 12)	Number of subjects analyzed in the Intent to treat population who have evaluable results	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group38

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group	GKT137831	Baseline Geom. Mean	705.72	90% Confidence Interval 637.07 to 774.36	mg/g
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group	Placebo	Baseline Geom. Mean	696.30	90% Confidence Interval 611.98 to 780.61	mg/g
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group	GKT137831	Adjusted End of treatment Geom. Mean	758.22	90% Confidence Interval 695.61 to 826.46	mg/g
Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group	Placebo	Adjusted End of treatment Geom. Mean	705.29	90% Confidence Interval 646.19 to 769.80	mg/g
Glucose Metabolism by Homeostatic Model Assessment (HOMA)	GKT137831	HOMA-IR Week 6 change from baseline	0.916	Standard Deviation 2.84	score on a scale
Glucose Metabolism by Homeostatic Model Assessment (HOMA)	Placebo	HOMA-IR Week 6 change from baseline	2.013	Standard Deviation 1.943	score on a scale
Glucose Metabolism by Homeostatic Model Assessment (HOMA)	GKT137831	HOMA-IR Week 12 change from baseline	0.344	Standard Deviation 2.32	score on a scale
Glucose Metabolism by Homeostatic Model Assessment (HOMA)	Placebo	HOMA-IR Week 12 change from baseline	-1.833	Standard Deviation 3.95	score on a scale
Glucose Metabolism by Homeostatic Model Assessment (HOMA)	GKT137831	HOMA-B Week 6 change from baseline	12.94	Standard Deviation 24.06	score on a scale
Glucose Metabolism by Homeostatic Model Assessment (HOMA)	Placebo	HOMA-B Week 6 change from baseline	50.10	Standard Deviation 75.81	score on a scale

1 to 10 of 38Source ClinicalTrials.gov

See all 38 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GKT137831	68
Overall Study	STARTED	Placebo	68
Overall Study	COMPLETED	GKT137831	64
Overall Study	COMPLETED	Placebo	61
Overall Study	NOT COMPLETED	GKT137831	4
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events72

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Bronchitis	Infections and infestations	GKT137831	2	68	2
other	Bronchitis	Infections and infestations	Placebo	2	68	2
other	Nasopharyngitis	Infections and infestations	GKT137831	2	68	2
other	Nasopharyngitis	Infections and infestations	Placebo	2	68	2
other	Tooth abscess	Infections and infestations	GKT137831	0	68	0
other	Tooth abscess	Infections and infestations	Placebo	2	68	2
other	Upper respiratory tract infection	Infections and infestations	GKT137831	4	68	4
other	Upper respiratory tract infection	Infections and infestations	Placebo	2	68	2
other	Urinary Tract infection	Infections and infestations	GKT137831	2	68	2
other	Urinary Tract infection	Infections and infestations	Placebo	2	68	2

1 to 10 of 72Source ClinicalTrials.gov

See all 72 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GKT137831	0	68
Total, all-cause mortality	Placebo	0	68
Total, other adverse events	GKT137831	33	68
Total, other adverse events	Placebo	42	68
Total, serious adverse events	GKT137831	3	68
Total, serious adverse events	Placebo	5	68

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41805697	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
GKT137831 vs Placebo: deaths from any cause	Trial comparisons
GKT137831 vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02010242

GET https://conductscience.org/api/trials/v1/NCT02010242/results?page=2

API reference For AI assistants