A Phase 4 interventional study of Exenatide Extended Release for Inj Susp 2 MG and Placebo in Type2 Diabetes and Kidney Diseases, sponsored by University at Buffalo. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by University at Buffalo · Phase 4, Interventional, and Treatment
This is a prospective study to evaluate effect of Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo.
This is a prospective study to evaluate effect of Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo. The similarities in baseline values between the study groups will be compared using appropriate parametric tests. Transformations of the data on order to meet statistical assumptions may be considered. All statistical analysis will be carried out using SPSS software (SPSS Inc, Chicago, Illinois) based on intention to treat principle. Data will be presented as mean±standard error. The primary endpoint of the study is the change from baseline in albuminuria level at weeks 12, 26, 39 and 56 following Exenatide extended release and placebo treatments. Fasting samples collected at weeks 0, 12, 26, 39 and 56 will be used for this assessment with values at week 0 considered as baseline. Changes from baselines form both drugs arms will be compared to those from the placebo arms in both the micro and macroalbuminuria groups. The statistical analysis will be done using mixed model for repeated measurement (MMRM) analysis with assigned α value of 0.05. Our preliminary data on retrospective analysis of the difference in albuminuria following GLP-1RA treatment for 2.5 yrs in T2DM patients with micro and macroalbuminuria show regression of albuminuria (UACR) by approximately 55mg/mg and 500mg/g (about 50% reduction), respectively. Conservatively estimating a difference in the change from baseline in albuminuria after 1 year between the Exenatide extended release and placebo groups (across both albuminuria groups) of 60mg/g, with standard deviation of no more than 91mg/g, a sample size of 38 patients per group should provide adequate power (beta = 0.2) to detect a significant difference (alpha = 0.05). Assuming a drop-out rate of 15% and 2:1 drug:placebo randomization ratio, 60 active and 30 control will be recruited for a total of 90 patients (rounded up). Patients will be enrolled based on a predetermined stratification according to the two albuminuria categories (micro and macro at 1:1 ratio) with 45 patients in each.
The secondary end points include the comparison of the changes in albuminuria based on baseline albuminuria category (micro or macro), creatinine clearance, Cystatin C, TGFβ, type I and IV collagen, CTGF, and fibronectin levels, the expression of SMAD3, SMAD4, NQO-1, GST-1P and HO-1, Nrf-2/keap-1 system activation between the Exenatide extended release and placebo groups and across albuminuria categories
3,843 studies on the registry are indexed under Kidney Diseases; 492 are open to participants now.
This study's enrollment of 15 is below the median of 70 across 2,645 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →University at Buffalo is the lead sponsor of 76 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as:
Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo.
Drug: Exenatide Extended Release for Inj Susp 2 MG
Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release.
Drug: Placebo
Exenatide extended release treatment weekly for 1 year in T2DM patients with micro- and macroalbuminuria
Also known as: Bydureon
placebo treatment weekly for 1 year in type 2 diabetes with micro-and macroalbuminuria
Change From Baseline in Urinary Albuminuria Levels
change from baseline in 24-hr urinary albuminuria (albumin/creatine) level at week 52 following Exenatide extended release OR placebo treatments
Time frame: baseline and 52 weeks
| Milestone | Exenatide Extended Release | Placebo |
|---|---|---|
| Started | 7 | 8 |
| Completed | 4 | 5 |
| Not completed | 3 | 3 |
change from baseline in 24-hr urinary albuminuria (albumin/creatine) level at week 52 following Exenatide extended release OR placebo treatments
| microgram/mg creatinine | Exenatide Extended Release | Placebo |
|---|---|---|
| Change From Baseline in Urinary Albuminuria Levels | -32 ± 122 | -12 ± 132 |
Collected over 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exenatide Extended Release | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Placebo | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Age, Continuous(YEARS) | Exenatide Extended Release | Placebo | Total |
|---|---|---|---|
| Mean | 62 ± 8 | 65 ± 9 | 64 ± 8 |
| Sex: Female, Male(Participants) | Exenatide Extended Release | Placebo | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 4 | 5 | 9 |
| Race and Ethnicity Not Collected(Participants) | Exenatide Extended Release | Placebo | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Exenatide
University at Buffalo