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

NAFLD Clinical Trial

— ALT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03233178
• Other study ID #: ALT
• Status: Completed
• Phase: N/A
• First received: July 20, 2017
• Last updated: July 27, 2017
• Start date: January 2017
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: LMC Diabetes & Endocrinology Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 4000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fatty Liver
• NAFLD
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Other:
• Non-interventional

Locations

Country	Name	City	State
Canada	LMC Brampton	Brampton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
LMC Diabetes & Endocrinology Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control	Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control	1 year
Secondary	Change in Hemoglobin A1c from baseline to follow-up	Change in HbA1c from baseline to follow-up	1 year
Secondary	Change in Fasting Plasma Glucose from baseline to follow-up	Change in Fasting Plasma Glucose from baseline to follow-up	1 year
Secondary	Change in body weight from baseline to follow-up	Change in body weight from baseline to follow-up	1 year
Secondary	Change in Body Mass Index (BMI) from baseline to follow-up	Change in BMI from baseline to follow-up	1 year
Secondary	Change in Waist Circumference (WC) from baseline to follow-up	Change in WC from baseline to follow-up	1 year
Secondary	Change in triglycerides from baseline to follow-up	Change in triglycerides from baseline to follow-up	1 year