Trial Outcomes & Findings for GLP-1 Receptor Agonist Therapy and Albuminuria in Patients With Type 2 Diabetes (NCT NCT03029351)

Results Overview

change from baseline in 24-hr urinary albuminuria (albumin/creatine) level at week 52 following Exenatide extended release OR placebo treatments

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

15 participants

Primary outcome timeframe

baseline and 52 weeks

Results posted on

2024-04-16

Participant milestones
Measure	Exenatide Extended Release Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo. Exenatide Extended Release for Inj Susp 2 MG: Exenatide extended release treatment weekly for 1 year in T2DM patients with micro- and macroalbuminuria	Placebo Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release. Placebo: placebo treatment weekly for 1 year in type 2 diabetes with micro-and macroalbuminuria
Overall Study STARTED	7	8
Overall Study COMPLETED	4	5
Overall Study NOT COMPLETED	3	3

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Exenatide Extended Release n=7 Participants Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo. Exenatide Extended Release for Inj Susp 2 MG: Exenatide extended release treatment weekly for 1 year in T2DM patients with micro- and macroalbuminuria	Placebo n=8 Participants Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release. Placebo: placebo treatment weekly for 1 year in type 2 diabetes with micro-and macroalbuminuria	Total n=15 Participants Total of all reporting groups
Age, Continuous	62 YEARS STANDARD_DEVIATION 8 • n=7 Participants	65 YEARS STANDARD_DEVIATION 9 • n=8 Participants	64 YEARS STANDARD_DEVIATION 8 • n=15 Participants
Sex: Female, Male Female	3 Participants n=7 Participants	3 Participants n=8 Participants	6 Participants n=15 Participants
Sex: Female, Male Male	4 Participants n=7 Participants	5 Participants n=8 Participants	9 Participants n=15 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

Timeframe: baseline and 52 weeks

change from baseline in 24-hr urinary albuminuria (albumin/creatine) level at week 52 following Exenatide extended release OR placebo treatments

Outcome measures
Measure	Exenatide Extended Release n=5 Participants Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo. Exenatide Extended Release for Inj Susp 2 MG: Exenatide extended release treatment weekly for 1 year in T2DM patients with micro- and macroalbuminuria	Placebo n=5 Participants Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release. Placebo: placebo treatment weekly for 1 year in type 2 diabetes with micro-and macroalbuminuria
Change From Baseline in Urinary Albuminuria Levels	-32 microgram/mg creatinine Standard Error 122	-12 microgram/mg creatinine Standard Error 132

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

State University of NY at Buffalo

Phone: 7165351852