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

Registration

Registration

NCT02251431

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE3

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

57

Start

2015-11

Primary completion

2019-12

Lead sponsor

Baylor Research Institute

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease; Left Ventricular Diastolic Dysfunction

Interventions

DRUG:BYDUREON; DRUG:Placebo

Results posted

TRUE

Secondary identifiers

OTHER_GRANT:D5551L00004/ISSEXEN0013

Registered primary outcomes

• Galectin-3 [38 weeks]
• ST2 [38 weeks]
• NGAL [38 weeks]
• KIM-1 [38 weeks]
• L-FABP [38 weeks]
• IL-18 [38 weeks]
• Alpha GST [38 weeks]
• Troponin I [38 weeks]
• Pi GST [38 weeks]
• NAG [38 weeks]
• Cystatin-C [38 weeks]
• BNP [38 weeks]
• ACR [38 weeks]