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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 (ALT)

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ClinicalTrials.gov Identifier: NCT03233178
Recruitment Status : Completed
First Posted : July 28, 2017
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
LMC Diabetes & Endocrinology Ltd.

Tracking Information
First Submitted Date July 20, 2017
First Posted Date July 28, 2017
Last Update Posted Date July 28, 2017
Actual Study Start Date January 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 27, 2017)
Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control [ Time Frame: 1 year ]
Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 27, 2017)
  • Change in Hemoglobin A1c from baseline to follow-up [ Time Frame: 1 year ]
    Change in HbA1c from baseline to follow-up
  • Change in Fasting Plasma Glucose from baseline to follow-up [ Time Frame: 1 year ]
    Change in Fasting Plasma Glucose from baseline to follow-up
  • Change in body weight from baseline to follow-up [ Time Frame: 1 year ]
    Change in body weight from baseline to follow-up
  • Change in Body Mass Index (BMI) from baseline to follow-up [ Time Frame: 1 year ]
    Change in BMI from baseline to follow-up
  • Change in Waist Circumference (WC) from baseline to follow-up [ Time Frame: 1 year ]
    Change in WC from baseline to follow-up
  • Change in triglycerides from baseline to follow-up [ Time Frame: 1 year ]
    Change in triglycerides from baseline to follow-up
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief 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
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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This study will include patients with T2DM who are patients at LMC Diabetes & Endocrinology. Patients will be included in the treatment cohorts if they initiated canagliflozin, dapagliflozin, liraglutide or sitagliptin, between January 2011 and December 2015, and did not discontinue the treatment prior to 6 weeks of being on the medication. The control group will include patients with T2DM who are patients at LMC Diabetes & Endocrinology, and who did not initiate any new diabetes treatment between June 2014 and June 2015.
Condition
  • T2DM (Type 2 Diabetes Mellitus)
  • Fatty Liver
  • NAFLD
Intervention Other: Non-interventional
Study Groups/Cohorts
  • SGLT2
    Patients initiating SGLT2 inhibitors
    Intervention: Other: Non-interventional
  • Liraglutide
    Patients initiation liraglutide
    Intervention: Other: Non-interventional
  • Sitagliptin
    Patients initiating sitagliptin
    Intervention: Other: Non-interventional
  • Control Group
    Patients who did not initiate any new anti-hyperglycemic treatment
    Intervention: Other: Non-interventional
Publications * Bajaj HS, Brown RE, Bhullar L, Sohi N, Kalra S, Aronson R. SGLT2 inhibitors and incretin agents: Associations with alanine aminotransferase activity in type 2 diabetes. Diabetes Metab. 2018 Dec;44(6):493-499. doi: 10.1016/j.diabet.2018.08.001. Epub 2018 Aug 24.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 27, 2017)
4000
Original Actual Enrollment Same as current
Actual Study Completion Date June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03233178
Other Study ID Numbers ALT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party LMC Diabetes & Endocrinology Ltd.
Study Sponsor LMC Diabetes & Endocrinology Ltd.
Collaborators Not Provided
Investigators Not Provided
PRS Account LMC Diabetes & Endocrinology Ltd.
Verification Date July 2017