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

NCT03029351 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 1981 GLP
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type2 Diabetes; Kidney Diseases

Keywords

albuminuria; GLP-1 Receptor Agonist; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  baseline and 52 weeks

Study Arms (2)

Exenatide extended release

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Exenatide Extended Release for Inj Susp 2 MG DRUG

Exenatide extended release treatment weekly for 1 year in T2DM patients with micro- and macroalbuminuria

Also known as: Bydureon

Exenatide extended release

Placebo DRUG

placebo treatment weekly for 1 year in type 2 diabetes with micro-and macroalbuminuria

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Aspartate aminotransferase (AST) \>3x upper limit of normal (ULN) and/or alanine aminotransferase (ALT) \>3x ULN
• Total bilirubin \>2.0 mg/dL (34.2 µmol/L)
• Positive serologic evidence of current infectious liver disease including Hepatitis B viral antibody IGM, Hepatitis B surface antigen and Hepatitis C virus antibody
• 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).

Sponsors & Collaborators

• University at Buffalo: lead
• AstraZeneca: collaborator

Study Sites (1)

Diabetes Endocrinology Research Center of WNY

Williamsville, New York, 14221, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Albuminuria; Diabetes Mellitus, Type 2

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Paresh Dandona
• Organization: State University of NY at Buffalo

dandona@buffalo.edu

7165351852

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: January 10, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 16, 2024
• Results First Posted: April 16, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)