Current partner codePEPTIDESDE
NCT06182891·Not applicable·INTERVENTIONAL

Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Status

Completed

Phase

Not applicable

Enrollment

300

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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

From registration to results.

  1. First posted

    Dec 27, 2023

  2. Study start

    Oct 30, 2021

  3. Primary completion

    Jun 30, 2023

  4. Study completion

    Oct 30, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Dec 27, 2023

Outcomes

What the study measures.

Primary outcomes

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

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.

Secondary outcomes

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

Evaluation of the cystatin C

Time frame · 3,6 and 12 months after dulaglutide injection treatment

the changes in the cystatin C

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).

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

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 locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Department of Endocrinology

Xuzhou, Jiangsu, China

Related trials

More studies on Dulaglutide.

Related PeptideStat pages

Put the record in context.

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