CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 57 enrolled
Drug / intervention
BYDUREON +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02251431
NCT02251431Phase 3Completed
CompareCT.gov

MB001-067 A PROSPECTIVE, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, RANDOMIZED TRIAL OF EXTENDED RELEASE EXENATIDE VERSUS PLACEBO (COHORT A) AND A PROSPECTIVE, SINGLE GROUP, OPEN-LABEL, BLINDED OUTCOME TRIAL OF EXTENDED RELEASE EXENATIDE (COHORT B) IN DIABETIC PATIENTS WITH TYPE 4 CARDIORENAL SYNDROME (EXTEND-CRS TRIAL) AMENDMENT 3

Baylor Research Institute·interventional·Posted Sep 29, 2014·Updated Feb 19, 2026

In Brief

A Phase 3 clinical trial evaluating BYDUREON and Placebo for Type 2 Diabetes Mellitus and 2 related conditions. Completed, enrolled 57 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedSep 29, 2014
Enrollment StartNov 1, 2015
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.8 years ago

Interventions

BYDUREONdrug

Exenatide-extended release, Cohorts A and B

Placebodrug

Cohort A only