Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

Conditions
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Type 2 Diabetic Nephropathy

Intervention / Treatment
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* Drug: Dulaglutide Injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dulaglutide<br>Dulaglutide was injected subcutaneously at standard dose and frequency for consecutive 12 months. | Drug: Dulaglutide Injection<br>* 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.<br>* Other names: Other hypoglycemic agents not including GLP-1 receptor agonists;|
| Active Comparator: other hypoglycemic agents not including GLP-1 receptor agonists<br>Other hypoglycemic agents not including GLP-1 receptor agonists were used at standard dose and frequency for consecutive 12 months. | Drug: Dulaglutide Injection<br>* 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.<br>* Other names: Other hypoglycemic agents not including GLP-1 receptor agonists;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dulaglutide, diabetic nephropathy, renoprotective effects