NCT06182891

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

November 7, 2023

Last Update Submit

December 24, 2023

Conditions

Type 2 Diabetic Nephropathy

Keywords

dulaglutidediabetic nephropathyrenoprotective effects

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Evaluation of the estimated glomerular filtration rate

    3,6 and 12 months after dulaglutide injection treatment

  • Evaluation of the cystatin C

    3,6 and 12 months after dulaglutide injection treatment

  • Evaluation of adverse event

    3,6 and 12 months after dulaglutide injection treatment

Study Arms (2)

Dulaglutide

EXPERIMENTAL

Dulaglutide was injected subcutaneously at standard dose and frequency for consecutive 12 months.

Drug: Dulaglutide Injection

other hypoglycemic agents not including GLP-1 receptor agonists

ACTIVE COMPARATOR

Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months.

Drug: Dulaglutide Injection

Interventions

Dulaglutide InjectionDRUG

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.

Also known as: Other hypoglycemic agents not including GLP-1 receptor agonists
Dulaglutideother hypoglycemic agents not including GLP-1 receptor agonists

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with other types of kidney disease
  • Urinary tract infection
  • Type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Endocrinology

Xuzhou, Jiangsu, 221002, China

Location

Related Publications (1)

  • Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.

    PMID: 39963952DERIVED

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

dulaglutide

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Renhao Wang, Ph.D

    The Affiliated Hospital of Xuzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2023

First Posted

December 27, 2023

Study Start

October 30, 2021

Primary Completion

June 30, 2023

Study Completion

October 30, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)