Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Type 2 Diabetic Nephropathy Clinical Trial

Official title:

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06182891
• Other study ID #: XYFY2021-KL236-02
• Status: Completed
• Phase: N/A
• Start date: October 30, 2021
• Est. completion date: October 30, 2023

Study information

• Verified date: December 2023
• Source: The Affiliated Hospital of Xuzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All adults aged 18 and above

• No minors involved in the study

• Diabetic Nephropathy defined as a urinary albumin-to-creatinine ratio =30 mg/g at least twice in three measurements within a period of 3-6 months

Exclusion Criteria:

• Patients with other types of kidney disease

• Urinary tract infection

• Type 1 diabetes

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Kidney Diseases
• Type 2 Diabetic Nephropathy

Intervention

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.

Locations

Country	Name	City	State
China	Department of Endocrinology	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Xuzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the urinary albumin-to-creatinine ratio	the changes in the urinary albumin-to-creatinine ratio	3,6 and 12 months after dulaglutide injection treatment
Primary	Evaluation of the biomarkers of the epithelial-mesenchymal transition process	the changes in the biomarkers of the epithelial-mesenchymal transition process from the baseline at 3, 6 and 12 months. These biomarkers of the epithelial-mesenchymal transition process include E-cadherin and periostin.	3,6 and 12 months after dulaglutide injection treatment
Secondary	Evaluation of the estimated glomerular filtration rate	the changes in the estimated glomerular filtration rate	3,6 and 12 months after dulaglutide injection treatment
Secondary	Evaluation of the cystatin C	the changes in the cystatin C	3,6 and 12 months after dulaglutide injection treatment
Secondary	Evaluation of adverse event	Tolerability and safety outcomes included the incidence of hypoglycemia, gastrointestinal reaction and other adverse events, which were recorded in detail at follow-up (3,6 and 12 months after dulaglutide injection treatment).	3,6 and 12 months after dulaglutide injection treatment