Trial · NCT02251431

Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome

NCT02251431, Phase 3, Completed, Baylor Research Institute; results first posted 2023-05-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome. Trials, record NCT02251431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02251431

On this page

Trial

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

Title: Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
NCT number: NCT02251431
Status: Completed
Phases: Phase 3
Enrollment: 57 participants, actual
Lead sponsor: Baylor Research Institute
Conditions: Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
Interventions: BYDUREON, Placebo
First posted: 2014-09-29
Last updated: 2026-02-19
Results first posted: 2023-05-17
Limitations and caveats: Our recruitment stopped early due to low accrual rate. Hence, null findings may be a result of lack of statistical power. Accordingly, our results should be interpreted as hypothesis-generating.

Source ClinicalTrials.gov

Registered outcomes13

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

List	Outcome	Time frame	Description
Primary	Galectin-3	38 weeks	Mean change in plasma galectin-3 (pg/ml)
Primary	ST2	38 weeks	Mean change in plasma ST2 (pg/ml)
Primary	NGAL	38 weeks	Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio
Primary	KIM-1	38 weeks	Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio
Primary	L-FABP	38 weeks	Mean change in urine L-type fatty acid binding protein:Cr ratio
Primary	IL-18	38 weeks	Mean change in urine interleukin-18:Cr ratio
Primary	Alpha GST	38 weeks	Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio
Primary	Troponin I	38 weeks	Mean change in plasma ultrasensitive troponin I (pg/ml)
Primary	Pi GST	38 weeks	Mean change in pi glutathione S-transferase (piGST):Cr ratio
Primary	NAG	38 weeks	Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Galectin-3	38 weeks	pg/ml	MEAN
PRIMARY	ST2	38 weeks	pg/ml	MEAN
PRIMARY	NGAL	38 weeks	ng/mmol Creat	MEAN
PRIMARY	KIM-1	38 weeks	ng/mmol Creat	MEAN
PRIMARY	L-FABP	38 weeks	ng/mmol Creat	MEAN
PRIMARY	IL-18	38 weeks	pg/mmol Creat	MEAN
PRIMARY	Alpha GST	38 weeks	ng/mmol Creat	MEAN
PRIMARY	Troponin I	38 weeks	pg/ml	MEAN
PRIMARY	Pi GST	38 weeks	ng/mmol Creat	MEAN
PRIMARY	NAG	38 weeks	ng/mmol Creat	MEAN

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group52

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

Outcome	Group	Category	Value	Spread	Units
Galectin-3	Exenatide-extended Release	Baseline	9570.91	Standard Deviation 4990.06	pg/ml
Galectin-3	Placebo	Baseline	9266.7	Standard Deviation 6032.8	pg/ml
Galectin-3	Exenatide-extended Release	End of study (38th week)	9539.21	Standard Deviation 3893.04	pg/ml
Galectin-3	Placebo	End of study (38th week)	8098.78	Standard Deviation 6272.55	pg/ml
ST2	Exenatide-extended Release	Baseline	635.2	Standard Deviation 449.82	pg/ml
ST2	Placebo	Baseline	443.18	Standard Deviation 380.34	pg/ml
ST2	Exenatide-extended Release	End of study (38th week)	524.68	Standard Deviation 423.61	pg/ml
ST2	Placebo	End of study (38th week)	534.53	Standard Deviation 302.89	pg/ml
NGAL	Exenatide-extended Release	Baseline	17.35	Standard Deviation 29.01	ng/mmol Creat
NGAL	Placebo	Baseline	18.44	Standard Deviation 25.01	ng/mmol Creat

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Exenatide-extended Release	29
Overall Study	STARTED	Placebo	28
Overall Study	COMPLETED	Exenatide-extended Release	29
Overall Study	COMPLETED	Placebo	28
Overall Study	NOT COMPLETED	Exenatide-extended Release	0
Overall Study	NOT COMPLETED	Placebo	0

Source ClinicalTrials.gov

Adverse events6

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	Injection site reaction	General disorders	Exenatide-extended Release	15	29	28
other	Injection site reaction	General disorders	Placebo	10	28	13
other	Gastrointestinal events, myalgia, fatigue	Gastrointestinal disorders	Exenatide-extended Release	20	29	61
other	Gastrointestinal events, myalgia, fatigue	Gastrointestinal disorders	Placebo	21	28	107
serious	NSTEMI (non ST elevated myocardial infarction)	Cardiac disorders	Exenatide-extended Release	0	29	0
serious	NSTEMI (non ST elevated myocardial infarction)	Cardiac disorders	Placebo	1	28	1

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Exenatide-extended Release	0	29
Total, all-cause mortality	Placebo	0	28
Total, other adverse events	Exenatide-extended Release	20	29
Total, other adverse events	Placebo	21	28
Total, serious adverse events	Exenatide-extended Release	0	29
Total, serious adverse events	Placebo	1	28

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1080957	BACKGROUND	PubMed
17239676	BACKGROUND	PubMed
20620723	BACKGROUND	PubMed
20929995	BACKGROUND	PubMed
21802579	BACKGROUND	PubMed
22249510	BACKGROUND	PubMed
23482076	BACKGROUND	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
Exenatide-extended Release vs Placebo: deaths from any cause	Trial comparisons
Exenatide-extended Release 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.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license 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/NCT02251431

GET https://conductscience.org/api/trials/v1/NCT02251431/results?page=2

API reference For AI assistants