Phase 3
N=57
Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
Type 2 Diabetes Mellitus · Chronic Kidney Disease · Left Ventricular Diastolic Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT02251431 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
May 2023
Primary outcome: Primary: Galectin-3 — 9570.91; 9266.7; 9539.21; 8098.78 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BYDUREON (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baylor Research Institute
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Galectin-3 |
9570.91; 9266.7; 9539.21; 8098.78 | — |
| PRIMARY ST2 |
635.2; 443.18; 524.68; 534.53 | — |
| PRIMARY NGAL |
17.35; 18.44; 14.01; 24.39 | — |
| PRIMARY KIM-1 |
0.1; 0.13; 0.13; 0.1 | — |
| PRIMARY L-FABP |
2.61; 3.24; 2.05; 3 | — |
| PRIMARY IL-18 |
1.68; 3.48; 1.96; 2.68 | — |
| PRIMARY Alpha GST |
0.06; 0.67; 0.05; 0.27 | — |
| PRIMARY Troponin I |
230.85; 415.65; 238.53; 504.48 | — |
| PRIMARY Pi GST |
2.2; 3.99; 3.03; 4.27 | — |
| PRIMARY NAG |
17.35; 18.44; 14.01; 24.39 | — |
| PRIMARY Cystatin-C |
2.07; 1.84; 1.47; 1.57 | — |
| PRIMARY BNP |
4.87; 9.88; 5.59; 14.02 | — |
| PRIMARY ACR |
6678.23; 9713.65; 3963.49; 9825.2 | — |
Summary
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.
Eligibility Criteria
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 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 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
Data sourced from ClinicalTrials.gov (NCT02251431). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.