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

TerminatedPhase 4

Sponsor: University at Buffalo

Conditions: Type2 Diabetes, Kidney Diseases

Interventions: Exenatide Extended Release for Inj Susp 2 MG, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 85 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (1)

Williamsville, New York, United States