Trial Outcomes & Findings for Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome (NCT NCT02251431)

Results Overview

Mean change in plasma galectin-3 (pg/ml)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

57 participants

Primary outcome timeframe

38 weeks

Results posted on

2023-05-17

Participant Flow

Participant milestones

Participant milestones
Measure	Exenatide-extended Release Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo Matching placebo subcutaneously once per week x 38 weeks
Overall Study STARTED	29	28
Overall Study COMPLETED	29	28
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks	Total n=57 Participants Total of all reporting groups
Age, Continuous	57.78 Years STANDARD_DEVIATION 12.83 • n=5 Participants	55.17 Years STANDARD_DEVIATION 9.64 • n=7 Participants	56.50 Years STANDARD_DEVIATION 11.35 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	14 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Diabetes	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: 38 weeks

Mean change in plasma galectin-3 (pg/ml)

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
Galectin-3 Baseline	9570.91 pg/ml Standard Deviation 4990.06	9266.7 pg/ml Standard Deviation 6032.8
Galectin-3 End of study (38th week)	9539.21 pg/ml Standard Deviation 3893.04	8098.78 pg/ml Standard Deviation 6272.55

PRIMARY outcome

Timeframe: 38 weeks

Mean change in plasma ST2 (pg/ml)

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
ST2 Baseline	635.2 pg/ml Standard Deviation 449.82	443.18 pg/ml Standard Deviation 380.34
ST2 End of study (38th week)	524.68 pg/ml Standard Deviation 423.61	534.53 pg/ml Standard Deviation 302.89

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine neutrophil gelatinase associated lipocalin (NGAL):creatinine (Cr) ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
NGAL Baseline	17.35 ng/mmol Creat Standard Deviation 29.01	18.44 ng/mmol Creat Standard Deviation 25.01
NGAL End of study (38th week)	14.01 ng/mmol Creat Standard Deviation 14.87	24.39 ng/mmol Creat Standard Deviation 40.37

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine kidney injury molecule-1 (KIM-1):Cr ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
KIM-1 Baseline	0.1 ng/mmol Creat Standard Deviation 0.08	0.13 ng/mmol Creat Standard Deviation 0.09
KIM-1 End of study (38th week)	0.13 ng/mmol Creat Standard Deviation 0.14	0.1 ng/mmol Creat Standard Deviation 0.05

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine L-type fatty acid binding protein:Cr ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
L-FABP Baseline	2.61 ng/mmol Creat Standard Deviation 3.72	3.24 ng/mmol Creat Standard Deviation 4.17
L-FABP End of study (38th week)	2.05 ng/mmol Creat Standard Deviation 2.18	3 ng/mmol Creat Standard Deviation 2.85

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine interleukin-18:Cr ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
IL-18 Baseline	1.68 pg/mmol Creat Standard Deviation 2.4	3.48 pg/mmol Creat Standard Deviation 4.69
IL-18 End of study (38th week)	1.96 pg/mmol Creat Standard Deviation 3.5	2.68 pg/mmol Creat Standard Deviation 2.48

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine alpha glutathione S-transferase (αGST):Cr ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
Alpha GST Baseline	0.06 ng/mmol Creat Standard Deviation 0.2	0.67 ng/mmol Creat Standard Deviation 1.83
Alpha GST End of study (38th week)	0.05 ng/mmol Creat Standard Deviation 0.16	0.27 ng/mmol Creat Standard Deviation 0.56

PRIMARY outcome

Timeframe: 38 weeks

Mean change in plasma ultrasensitive troponin I (pg/ml)

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
Troponin I Baseline	230.85 pg/ml Standard Deviation 282.73	415.65 pg/ml Standard Deviation 446.33
Troponin I End of study (38th week)	238.53 pg/ml Standard Deviation 283.59	504.48 pg/ml Standard Deviation 599.4

PRIMARY outcome

Timeframe: 38 weeks

Mean change in pi glutathione S-transferase (piGST):Cr ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
Pi GST Baseline	2.2 ng/mmol Creat Standard Deviation 3.41	3.99 ng/mmol Creat Standard Deviation 3.96
Pi GST End of study (38th week)	3.03 ng/mmol Creat Standard Deviation 5.67	4.27 ng/mmol Creat Standard Deviation 4.67

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine N-acetyl-β-D-glucosaminidase (NAG):Cr ratio

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
NAG Baseline	17.35 ng/mmol Creat Standard Deviation 29.01	18.44 ng/mmol Creat Standard Deviation 25.01
NAG End of study (38th week)	14.01 ng/mmol Creat Standard Deviation 14.87	24.39 ng/mmol Creat Standard Deviation 40.37

PRIMARY outcome

Timeframe: 38 weeks

Mean paired change in urine cystatin-C:Cr ratio (uCysC:Cr)

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
Cystatin-C Baseline	2.07 ng/mmol Creat Standard Deviation 2.64	1.84 ng/mmol Creat Standard Deviation 1.19
Cystatin-C End of study (38th week)	1.47 ng/mmol Creat Standard Deviation 1.22	1.57 ng/mmol Creat Standard Deviation 1.17

PRIMARY outcome

Timeframe: 38 weeks

Mean change in plasma B-type natriuretic peptide BNP (pg/ml)

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
BNP Baseline	4.87 pg/ml Standard Deviation 9.3	9.88 pg/ml Standard Deviation 14.52
BNP End of study (38th week)	5.59 pg/ml Standard Deviation 9.59	14.02 pg/ml Standard Deviation 22.53

PRIMARY outcome

Timeframe: 38 weeks

Mean change in urine albumin:Cr ratio (ACR)

Outcome measures

Outcome measures
Measure	Exenatide-extended Release n=29 Participants Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 Participants Matching placebo subcutaneously once per week x 38 weeks
ACR Baseline	6678.23 ng/mmol Creat Standard Deviation 12662.79	9713.65 ng/mmol Creat Standard Deviation 14380.38
ACR End of study (38th week)	3963.49 ng/mmol Creat Standard Deviation 3101.13	9825.2 ng/mmol Creat Standard Deviation 9539.34

Adverse Events

Exenatide-extended Release

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Exenatide-extended Release n=29 participants at risk Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 participants at risk Matching placebo subcutaneously once per week x 38 weeks
Cardiac disorders NSTEMI (non ST elevated myocardial infarction)	0.00% 0/29 • 38 weeks from study initiation	3.6% 1/28 • Number of events 1 • 38 weeks from study initiation

Other adverse events

Other adverse events
Measure	Exenatide-extended Release n=29 participants at risk Exenatide-extended release (BYDUREON™) 2 mg subcutaneously once per week x 38 weeks	Placebo n=28 participants at risk Matching placebo subcutaneously once per week x 38 weeks
General disorders Injection site reaction	51.7% 15/29 • Number of events 28 • 38 weeks from study initiation	35.7% 10/28 • Number of events 13 • 38 weeks from study initiation
Gastrointestinal disorders Gastrointestinal events, myalgia, fatigue	69.0% 20/29 • Number of events 61 • 38 weeks from study initiation	75.0% 21/28 • Number of events 107 • 38 weeks from study initiation

Additional Information

Biostatistician

Baylor Scott & White Research Institute

Phone: 8033190755

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60