NCT06182891

Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: The Affiliated Hospital of Xuzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the real-world observational prospective study is to access the renoprotective effects of dulaglutide as well as to explore corresponding mechanisms in patients with Type 2 Diabetic Nephropathy.

Detailed description

Related studies have found that Glucagon-like peptide-1 (GLP-1) receptors are localized on a variety of tissues and cell types in addition to pancreatic β-cells, and GLP-1 and GLP-1 receptor agonists can exert diverse effect on multiple organs and tissues, with pleiotropic potential physiological, pathophysiological as well as pharmacological implications. Multiple clinical trials suggest that GLP-1 receptor agonists can exert renoprotective effects and persuasively inhibit the progression of kidney disease in type 2 diabetic patients. The beneficial effects of GLP-1 receptor agonists on Type 2 Diabetic Nephropathy, independent of their hypoglycemic ability, might are mediated by anti-oxidative stress, anti-inflammatory and natriuresis properties. However, it is not clear whether the above-mentioned properties are involved in the EMT process of renal tubular epithelial cells. All participants meeting all eligibility criteria received routine medical consultations. During routine medical visits, patients were randomized into two groups (1.07:1) to receive a total duration of 12 months of hypoglycemic therapy - dulaglutide plus other hypoglycemic agents not including GLP-1 receptor agonists (intervention group), and other hypoglycemic agents not including GLP-1 receptor agonists (control group). A random number method was applied for grouping in this study. Dulaglutide and other hypoglycemic agents were administered according to the drug package insert. Of course, the investigators decided on other background treatments for hypertension, hyperlipidemia, or cardiovascular-related risk factors based on the latest guidelines throughout the trial.

Conditions

• Type 2 Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	Dulaglutide Injection	Dulaglutide injection was injected subcutaneously at standard dose and frequency for consecutive 12 months in patients with type 2 diabetes and diabetic kidney disease. Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.

Timeline

• Start date: 2021-10-30
• Primary completion: 2023-06-30
• Completion: 2023-10-30
• First posted: 2023-12-27
• Last updated: 2023-12-27

Locations

1 site across 1 country: China