Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT02251431Other id014-149Other idD5551L00004/ISSEXEN0013

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 57 participants (actual)
Sponsor: Baylor Research Institute · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Nov 2015
Primary completion: Dec 2019
Completion: Dec 2019
First posted: 29 Sept 2014 (estimated)
Last update posted: 19 Feb 2026
Conditions: Type 2 Diabetes Mellitus · Chronic Kidney Disease · Left Ventricular Diastolic Dysfunction

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201520162017201820192020

Ph 3
Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
NCT02251431
Nov 2015 to Dec 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the quantitative impact of 38 weeks of treatment with exenatide extended-release injections versus placebo. on a cardiac biomarker blood test score, cardiac fibrosis seen on magnetic resonance scanning, cardiac strain identified by ultrasonography and strain rate imaging, and a kidney urine biomarker score.

Interventions

BYDUREONDrug
PlaceboDrug

Arms2

Experimental
Exenatide-extended release
Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks
Placebo comparator
Placebo
Matching placebo subcutaneously once per week x 38 weeks

Primary outcomes13

Outcomes the sponsor listed as primary.

Galectin-3
Time frame · 38 weeks
Registry description
Mean change in plasma galectin-3 (pg/ml)
ST2
Time frame · 38 weeks
Registry description
Mean change in plasma ST2 (pg/ml)
NGAL
Time frame · 38 weeks
Registry description
Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio
KIM-1
Time frame · 38 weeks
Registry description
Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio
L-FABP
Time frame · 38 weeks
Registry description
Mean change in urine L-type fatty acid binding protein:Cr ratio
IL-18
Time frame · 38 weeks
Registry description
Mean change in urine interleukin-18:Cr ratio
Alpha GST
Time frame · 38 weeks
Registry description
Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio
Troponin I
Time frame · 38 weeks
Registry description
Mean change in plasma ultrasensitive troponin I (pg/ml)
Pi GST
Time frame · 38 weeks
Registry description
Mean change in pi glutathione S-transferase (piGST):Cr ratio
NAG
Time frame · 38 weeks
Registry description
Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio
Cystatin-C
Time frame · 38 weeks
Registry description
Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)
BNP
Time frame · 38 weeks
Registry description
Mean change in plasma B-type natriuretic peptide BNP (pg/ml)
ACR
Time frame · 38 weeks
Registry description
Mean change in urine albumin:Cr ratio (ACR)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 38 weeks

Galectin-3

Group	Value (pg/ml)	Spread
Exenatide-extended Release	9570.91	4990.06
Placebo	9266.7	6032.8

Primary outcomeMean· 38 weeks

ST2

Group	Value (pg/ml)	Spread
Exenatide-extended Release	635.2	449.82
Placebo	443.18	380.34

Primary outcomeMean· 38 weeks

NGAL

Group	Value (ng/mmol Creat)	Spread
Exenatide-extended Release	17.35	29.01
Placebo	18.44	25.01

Primary outcomeMean· 38 weeks

KIM-1

Group	Value (ng/mmol Creat)	Spread
Exenatide-extended Release	0.1	0.08
Placebo	0.13	0.09

Primary outcomeMean· 38 weeks

L-FABP

Group	Value (ng/mmol Creat)	Spread
Exenatide-extended Release	2.61	3.72
Placebo	3.24	4.17

Primary outcomeMean· 38 weeks

IL-18

Group	Value (pg/mmol Creat)	Spread
Exenatide-extended Release	1.68	2.4
Placebo	3.48	4.69

Primary outcomeMean· 38 weeks

Alpha GST

Group	Value (ng/mmol Creat)	Spread
Exenatide-extended Release	0.06	0.2
Placebo	0.67	1.83

Primary outcomeMean· 38 weeks

Troponin I

Group	Value (pg/ml)	Spread
Exenatide-extended Release	230.85	282.73
Placebo	415.65	446.33

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Exenatide-extended ReleaseExenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	0 / 29	0 / 29	20 / 29
PlaceboMatching placebo subcutaneously once per week x 38 weeks	0 / 28	1 / 28	21 / 28

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2011

3 results

Risk of cardiovascular disease events in patients with type 2 diabetes prescribed the glucagon-like peptide 1 (GLP-1) receptor agonist exenatide twice daily or other glucose-lowering therapies: a retrospective analysis of the LifeLink database.

Best et al. 2011Diabetes carecited by 183

PMID 20929995PMC3005487DOI 10.2337/dc10-1393PUB-20929995

Free to read · publisher termsCC BY-NC-ND3 results

Read at source See results (3)

More studies

1 study on this page

Indexing hint: Review · 2011

Cardiovascular effects of glucagonlike peptide-1 agonists.

Davidson et al. 2011The American journal of cardiologycited by 58

PMID 21802579DOI 10.1016/j.amjcard.2011.03.046PUB-21802579

Rights unknown

Source link

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age ≥ 18 * Type 2 diabetes mellitus with hemoglobin A1C 6.6-9.9% with or without the use of insulin * Estimated glomerular filtration rate (eGFR) between 50 and 90 ml/min/1.73 m2 Exclusion Criteria: * Allergy or intolerance to gadolinium * Implanted cardiac pacemaker, defibrillator, loop recorder, or other implanted metallic device * Any other metallic implanted device that is a contra-indication to MRI scanning * eGFR \< 50 ml/min/1.73 m2 * eGFR \> 90 ml/min/1.73 m2 * Patient has ever been treated with an approved or investigational GLP-1 receptor agonist e.g. BYETTA™ (exenatide), BYDUREON™ (Exenatide extended-release), VICTOZA™ (liraglutide), or taspoglutide * Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial. * Disorders of iron metabolism * Collagen vascular diseases * Myocardial infarction * Use of DDP4 inhibitors, and PPAR gamma agonists * Pregnancy or planned pregnancy during the trial period * Hemoglobin A1C of ≥ 10.0% or \<6.6% * Fasting glucose ≥ 260 mg/dl * Clinically significant abnormal baseline laboratories * Morbid obesity or body girth that prohibits the ability to undergo echocardiography or MRI scanning with high-quality image results * Renal transplantation * Severe gastrointestinal, liver, or neurodegenerative disease * Decompensated liver cirrhosis (Child-Pugh score \>7) * New York Heart Association Class III or IV heart failure * Patients have alanine aminotransaminase (ALT) greater than 5 times the upper limit of the reference range. * Prior pancreatitis * Personal or family history of medullary thyroid adenoma or carcinoma (MTC) * Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). * History of severe hypoglycemia * Prior bariatric surgery

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