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

LMC Diabetes & Endocrinology Ltd.

Status: Completed

Conditions: Fatty Liver; NAFLD; T2DM (Type 2 Diabetes Mellitus)

Treatments: Other: Non-interventional

Study type: Observational

Funder types: Other

Identifiers

NCT03233178

ALT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Diagnosis of type 1 diabetes
• Patients who switched to one of the study treatments from another medication of the same medication class

Trial design

4,000 participants in 4 patient groups

SGLT2

Description:

Patients initiating SGLT2 inhibitors

Treatment:

Other: Non-interventional

Liraglutide

Description:

Patients initiation liraglutide

Treatment:

Other: Non-interventional

Sitagliptin

Description:

Patients initiating sitagliptin

Treatment:

Other: Non-interventional

Control Group

Description:

Patients who did not initiate any new anti-hyperglycemic treatment

Treatment:

Other: Non-interventional