Measurement of Alanine Aminotransaminase (ALT) Following Initiation of Antidiabetic Agents in Patients With Type 2 Diabetes in a Real-world Clinical Setting: a Retrospective Cohort Study
- Conditions
- NAFLDFatty LiverT2DM (Type 2 Diabetes Mellitus)
- Interventions
- Other: Non-interventional
- Registration Number
- NCT03233178
- Lead Sponsor
- LMC Diabetes & Endocrinology Ltd.
- Brief Summary
The primary objective of this study is to investigate the change in Alanine Aminotransaminase (ALT) in patients with Type 2 Diabetes Mellitus (T2DM) initiating Sodium Glucose Cotransporter 2 (SGLT2) inhibitors, liraglutide, or sitagliptin, compared to a control group of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that patients using Sodium Glucose Cotransporter 2 inhibitors (SGLT2i) will achieve a greater reduction in ALT compared to the control group.
- Detailed Description
Non-alcoholic fatty liver disease (NAFLD) is very commonly associated with type 2 diabetes mellitus (T2DM) 1. Alanine aminotransferase (ALT) is a common biomarker used to predict levels of NAFLD. The only class of antidiabetic agents thought to be protective of NAFLD are thiazolidinedione's. Few studies have investigated the effect of other antidiabetic agents on bio markers of fatty liver disease 2. A recent pooled analysis of randomized controlled trials that compared canagliflozin to either placebo or sitagliptin showed significant reductions in ALT in the canagliflozin cohorts, which were fully explained by HbA1c and body weight reductions 3. As well, a study that compared ALT change in patients initiating liraglutide found significant reductions in ALT, which was strongly correlated to reduction in body weight 4. However, the effect of different antidiabetic agents on bio markers of fatty liver disease is not well characterized.
The primary objective of this study is to investigate the change in ALT in patients with T2DM initiating SGLT2 inhibitors, liraglutide, or sitagliptin, compared to a control group of patients who did not initiate a new antihyperglycemic therapy. The hypothesis is that patients using SGLT2i will achieve a greater reduction in ALT compared to the control group.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4000
- Diagnosis of T2DM based upon historical clinical diagnosis
- Patients who initiated canagliflozin, dapagliflozin, liraglutide or sitagliptin by an LMC physician between January 2011 and December 2015, or patients who did not initiate a new diabetes therapy between June 2014 and June 2015.
- Diagnosis of type 1 diabetes
- Patients who switched to one of the study treatments from another medication of the same medication class
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Control Group Non-interventional Patients who did not initiate any new anti-hyperglycemic treatment SGLT2 Non-interventional Patients initiating SGLT2 inhibitors Liraglutide Non-interventional Patients initiation liraglutide Sitagliptin Non-interventional Patients initiating sitagliptin
- Primary Outcome Measures
Name Time Method Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control 1 year Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control
- Secondary Outcome Measures
Name Time Method Change in body weight from baseline to follow-up 1 year Change in body weight from baseline to follow-up
Change in Waist Circumference (WC) from baseline to follow-up 1 year Change in WC from baseline to follow-up
Change in Hemoglobin A1c from baseline to follow-up 1 year Change in HbA1c from baseline to follow-up
Change in Fasting Plasma Glucose from baseline to follow-up 1 year Change in Fasting Plasma Glucose from baseline to follow-up
Change in triglycerides from baseline to follow-up 1 year Change in triglycerides from baseline to follow-up
Change in Body Mass Index (BMI) from baseline to follow-up 1 year Change in BMI from baseline to follow-up
Trial Locations
- Locations (1)
LMC Brampton
🇨🇦Brampton, Ontario, Canada