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NCT Number: NCT06182891

Renoprotective Effects of Dulaglutide in Patients With Type 2 Diabetic Nephropathy

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.

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Key information

Conditions

Type 2 Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Endocrinology

Xuzhou, Jiangsu, 221002, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dulaglutide Injection

Drug

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

Primary outcomes

  1. 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

  2. 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

  1. 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

  2. Evaluation of the cystatin C

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

    the changes in the cystatin C

  3. 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).

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University

Other

Registry information

Official study title

Department of Pharmacy, the Affiliated Hospital of Xuzhou Medical University

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 27, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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