Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

December 24, 2023 updated by: The Affiliated Hospital of Xuzhou Medical University

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Xuzhou, Jiangsu, China, 221002
        • Department of Endocrinology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dulaglutide
Dulaglutide was injected subcutaneously at standard dose and frequency for consecutive 12 months.
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.
Other Names:
  • Other hypoglycemic agents not including GLP-1 receptor agonists
Active Comparator: other hypoglycemic agents not including GLP-1 receptor agonists
Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.
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.
Other Names:
  • Other hypoglycemic agents not including GLP-1 receptor agonists

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the urinary albumin-to-creatinine ratio
Time Frame: 3,6 and 12 months after dulaglutide injection treatment
the changes in the urinary albumin-to-creatinine ratio
3,6 and 12 months after dulaglutide injection treatment
Evaluation of the biomarkers of the epithelial-mesenchymal transition process
Time Frame: 3,6 and 12 months after dulaglutide injection treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the estimated glomerular filtration rate
Time Frame: 3,6 and 12 months after dulaglutide injection treatment
the changes in the estimated glomerular filtration rate
3,6 and 12 months after dulaglutide injection treatment
Evaluation of the cystatin C
Time Frame: 3,6 and 12 months after dulaglutide injection treatment
the changes in the cystatin C
3,6 and 12 months after dulaglutide injection treatment
Evaluation of adverse event
Time Frame: 3,6 and 12 months after dulaglutide injection treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Hospital of Xuzhou Medical University

Investigators

  • Study Director: Renhao Wang, Ph.D, The Affiliated Hospital of Xuzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

November 7, 2023

First Submitted That Met QC Criteria

December 24, 2023

First Posted (Estimated)

December 27, 2023

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 24, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XYFY2021-KL236-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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