Trial Outcomes & Findings for Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation (NCT NCT03961256)

NCT ID: NCT03961256

Last Updated: 2022-10-28

Results Overview

Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 9 participants
• Primary outcome timeframe: 12 months after transplantation
• Results posted on: 2022-10-28

Participant Flow

Participant milestones

Measure	Exenatide SR Intervention Group Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Overall Study STARTED	6	3
Overall Study COMPLETED	6	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation

Baseline characteristics by cohort

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care n=3 Participants Subjects received standard post-transplant care as per Mayo Clinic usual practice.	Total n=9 Participants Total of all reporting groups
Age, Continuous	48.5 years n=5 Participants	57.7 years n=7 Participants	53.5 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	9 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after transplantation

Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care n=3 Participants Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Progression From Prediabetes to Diabetes	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 24 months after transplantation

Population: Data was not collected nor analyzed for one subject in the standard of care arm

Number of subjects to have an increase in HbA1C or fasting blood sugar to diabetic range based on the American Diabetes Association (ADA) criteria after kidney transplantation

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care n=2 Participants Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Progression From Prediabetes to Diabetes	1 Participants	1 Participants

SECONDARY outcome

Timeframe: From enrollment, up to 20 months post-enrollment

Population: Data was not collected nor analyzed for one subject in the standard of care arm

A creatinine blood test measures the level of creatinine in the blood. Creatinine is a waste product that forms when creatine, which is found in the muscle, breaks down. Creatinine levels in the blood can provide the doctors with information about how well the kidneys are working. As measured in mg/dL units.

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care n=2 Participants Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Creatinine	1.7 mg/dL Interval 1.5 to 1.9	1.4 mg/dL Interval 1.2 to 1.6

SECONDARY outcome

Timeframe: 12 and 24 months after kidney transplantation

Population: Data was not collected nor analyzed for one subject in the standard of care arm

Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal.

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care n=2 Participants Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Hemoglobin A1c 12 months	5.6 percentage of glycated hemoglobin Interval 5.3 to 5.8	5.85 percentage of glycated hemoglobin Interval 5.3 to 6.4
Hemoglobin A1c 24 months	5.65 percentage of glycated hemoglobin Interval 5.6 to 6.7	5.75 percentage of glycated hemoglobin Interval 5.3 to 6.2

SECONDARY outcome

Timeframe: 12 and 24 months after kidney transplantation

Population: Data was not collected nor analyzed for one subject in the standard of care arm at 24 months

Number of subjects to experience mesangial expansion >20%. Mesangial expansion occurs due to increased deposition of extracellular matrix proteins, for example fibronectin, into the mesangium. Accumulation of extracellular matrix proteins then occurs due to insufficient degradation by matrix metalloproteinases.

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care n=3 Participants Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Incidence of Mesangial Expansion 12 months	0 Participants	0 Participants
Incidence of Mesangial Expansion 24 months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From enrollment, up to 20 months post-enrollment

Population: Deaths collected for the Exenatide SR Intervention Group only. Deaths were not collected for the Standard of Care arm

Number of subjects to experience death by any cause

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Incidence of Death	0 Participants	—

SECONDARY outcome

Timeframe: From enrollment, up to 20 months post-enrollment

Population: Graft loss collected for the Exenatide SR Intervention Group only. Graft Loss was not collected for the Standard of Care arm

The number of subjects to experience graft loss. Primary graft failure is defined as no evidence of engraftment or hematological recovery of donor cells, within the first month after transplant, without evidence of disease relapse. Secondary graft failure refers to the loss of a previously functioning graft, resulting in cytopenia involving at least two blood cell lineages.

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Graft Loss	0 Participants	—

SECONDARY outcome

Timeframe: 12 months

Total number of adverse events reported by the subjects that received the Exenatide SR Intervention

Outcome measures

Measure	Exenatide SR Intervention Group n=6 Participants Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly	Standard of Care Subjects received standard post-transplant care as per Mayo Clinic usual practice.
Adverse Events for Exenatide SR Intervention	10 Adverse Events	—

Adverse Events

Exenatide SR Intervention Group

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Exenatide SR Intervention Group n=6 participants at risk Subjects received, in addition to standard care, Exenatide SR 2 mg subcutaneous (SQ) weekly for 24 months. Exenatide SR: Exenatide SR 2 mg subcutaneous (SQ) weekly
General disorders Nausea	16.7% 1/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
General disorders Vomiting	16.7% 1/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
Gastrointestinal disorders Diarrhea	33.3% 2/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
Gastrointestinal disorders Constipation	33.3% 2/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
Gastrointestinal disorders Dyspepsia	16.7% 1/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
General disorders Abdominal pain	16.7% 1/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm
Skin and subcutaneous tissue disorders Erythema	33.3% 2/6 • Deaths were assessed up to 20 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were assessed up to 12 months. Deaths and Adverse Events collected for the Exenatide SR Intervention Group only. Deaths and Adverse Events were not collected for the Standard of Care arm

Additional Information

Mark D. Stegall, M.D.

Mayo Clinic

Phone: 507-266-2812

Email: Stegall.Mark@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place