Phase 4 · Exenatide

1981 trial results

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

Change From Baseline in Urinary Albuminuria Levels (microgram/mg creatinine), baseline and 52 weeks. Exenatide Extended Release: -32; Placebo: -12.

Participants
15
Status
terminated
Completed
2019-07
Sponsor
University at Buffalo

As posted on ClinicalTrials.gov (NCT03029351), updated at source Apr 16, 2024. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What 1981 measured first

Change From Baseline in Urinary Albuminuria Levelsmicrogram/mg creatinine · baseline and 52 weeks · mean
Exenatide Extended Releasen=5Placebon=5
-32(122)-12(132)
The trial

How 1981 was run

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.

  • Exenatide extended release: Exenatide extended release treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to placebo.
  • Placebo: Placebo treatment for 1 year on albuminuria levels in T2DM patients with micro- and macroalbuminuria compared to Exenatide extended release.
Who could join the trial

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.

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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