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Trial · Interventional

TerminatedPhase 4Results postedRegistry data

GLP-1 Receptor Agonist Therapy and Albuminuria in Patients With Type 2 Diabetes

Short name 1981

NCTNCT03029351 (opens ClinicalTrials.gov in a new tab)Other id1981 GLP
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 4
Enrollment
15 participants (actual)
Sponsor
University at Buffalo · Other
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
10 Jan 2017
Primary completion
Jul 2019
Completion
Jul 2019
First posted
24 Jan 2017 (estimated)
Last update posted
16 Apr 2024
Conditions
Type2 Diabetes · Kidney Diseases

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2017201820192020
  1. Ph 4

    1981

    NCT03029351

    10 Jan 2017 to Jul 2019

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Exenatide Extended Release for Inj Susp 2 MGDrug
  • PlaceboDrug

Arms2

  • Experimental

    Exenatide extended release

    Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo.

  • Placebo comparator

    Placebo

    Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Urinary Albuminuria Levels

    Time frame · baseline and 52 weeks

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· baseline and 52 weeks

Change From Baseline in Urinary Albuminuria Levels

GroupValue (microgram/mg creatinine)Spread
Exenatide Extended Release-32122
Placebo-12132

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Extended ReleaseExenatide 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 macroalbuminuria0 / 70 / 70 / 7
PlaceboPlacebo 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 macroalbuminuria0 / 80 / 80 / 8

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 85 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 Diabetes for at least 1 year. * Microalbuminuria for at least 6 months (UACR: 30-300 mg/g) * Macroalbuminuria for at least 6 months (UACR: \>300 mg/g) * HbA1c of ≤10% * Ages 18-65 years (inclusive of ages 18 and 65) * On ARBs/ACEi for at \>3months Exclusion Criteria: * Use of GLP-1 Receptor agonists or SGLT-2 inhibitors therapy in the last 3 months * History or risk for pancreatitis (e.g., history of gallstones, alcohol abuse, and hypertriglyceridemia) * Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months * Hepatic disease: Severe hepatic insufficiency and/or significant abnormal liver function defined as: 1. Aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN 2. Total bilirubin \>2.0 mg/dL (34.2 µmol/L) 3. Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody 4. Liver function tests more than 3 times the upper limit of normal * Renal impairment (serum eGFR \<30 ml/min) * HIV * Inability to give informed consent * History of gastroparesis * History of medullary thyroid carcinoma or MEN 2 syndrome * Alcoholism * Hypertriglyceridemia (\>500 mg/dl). * Any other life-threatening, non-cardiac disease * Uncontrolled hypertension (BP \> 160/100 mm of Hg) * Congestive Heart Failure class III or IV * Use of an investigational agent or therapeutic regimen within 30 days of study * Participation in any other concurrent clinical trial * Pregnant or breastfeeding patients or females of childbearing age not on 2 forms of acceptable contraceptives.

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