Effects of Lixisenatide on the primary prevention of diabetic kidney disease in population with high risk

Lead Investigator: Baocheng Chang, Tianjin Medical University
Title of Proposal Research: Effects of Lixisenatide on the primary prevention of diabetic kidney disease in population with high risk
Vivli Data Request: 7661
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Diabetic kidney disease (DKD) has become the leading cause of end stage renal disease (ESRD), which brings heavy economic and spiritual burden to diabetic patients. Microalbuminuria was taken as the classical marker of DKD diagnosis, while once diagnosed as DKD, even after aggressive treatment, most patients would not get well. Even mild increases in albuminuria or glomerular filtration rate (GFR) decline are associated with a substantial increased risk of cardiovascular disease and cardiovascular death. To identify patients with high risk for DKD and timely targeted treatments to prevent the development of DKD can be the most attractive breakthrough for diabetic patients. Our group has established the “Risk Prediction Model for Early Diabetic Kidney Disease” based on a systemic review and meta-analysis of twenty cohorts including 41,271 patients with type 2 diabetes. The results have already published in Diabetes Care in 2020. This risk prediction model consists 9 risk factors including age, body mass index (BMI), smoking history, diabetic retinopathy, HbA1c, systolic blood pressure (SBP), high density lipoprotein cholesterol (HDL-C), triglyceride (TG) and urinary albumin-to-creatinine ratio (UACR). Patient with a total score higher than 16.0 was taken as high risk for DKD, and of course, he would benefit from timely targeted treatment. This model can help detect patients with high risk for DKD rapidly and effectively, and is easy to use for both doctors and diabetic patients. The results may also guide patients receive timely and targeted treatment, which may further lower the incidence of DKD and medical cost. Study has shown that Glucagon-like peptide-1 (GLP-1) receptor agonists can reduce the risk of new-onset or progressive DKD in patients with type 2 diabetes. We are curious about whether GLP-1 receptor agonist especially Lixisenatide can achieve primary prevention for DKD through improving multiple risk factors.

In this study, we will use“Risk Prediction Model for Early Diabetic Kidney Disease”(Jiang,et al., 2020) published in Diabetes Care on 2020 to stratify the type 2 diabetic patients without DKD (UACR < 30mg/g, and eGFR ≥ 60ml/min/1.73m2) as very high-risk subgroup (score 27-37), high-risk subgroup (score 16-26.5), middle-risk subgroup (score 12-15.5) and low-risk subgroup (score < 12) according to their baseline information in both treatment group and control group. Clinical outcomes at the end of the study will be analyzed for each subgroup and included: 1. Incidence of DKD (UACR ≥ 30mg/g and/or eGFR < 60 ml/min/1.73m2) in each subgroup; 2. Risk score changes in each subgroup; 3. Effect of Lixisenatide on risk score of DKD; 4. Primary preventive effect of lixisenatide on DKD.

Requested Studies:

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome
Data Contributor: Sanofi
Study ID: NCT01147250
Sponsor ID: EFC11319