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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.

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.

Condition or disease Intervention/treatment
T2DM (Type 2 Diabetes Mellitus) Fatty Liver NAFLD Other: Non-interventional

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.

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Study Type : Observational
Actual Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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
Actual Study Start Date : January 2017
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Alanine

Group/Cohort Intervention/treatment
SGLT2
Patients initiating SGLT2 inhibitors
Other: Non-interventional
Liraglutide
Patients initiation liraglutide
Other: Non-interventional
Sitagliptin
Patients initiating sitagliptin
Other: Non-interventional
Control Group
Patients who did not initiate any new anti-hyperglycemic treatment
Other: Non-interventional



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in Hemoglobin A1c from baseline to follow-up [ Time Frame: 1 year ]
    Change in HbA1c from baseline to follow-up

  2. Change in Fasting Plasma Glucose from baseline to follow-up [ Time Frame: 1 year ]
    Change in Fasting Plasma Glucose from baseline to follow-up

  3. Change in body weight from baseline to follow-up [ Time Frame: 1 year ]
    Change in body weight from baseline to follow-up

  4. Change in Body Mass Index (BMI) from baseline to follow-up [ Time Frame: 1 year ]
    Change in BMI from baseline to follow-up

  5. Change in Waist Circumference (WC) from baseline to follow-up [ Time Frame: 1 year ]
    Change in WC from baseline to follow-up

  6. Change in triglycerides from baseline to follow-up [ Time Frame: 1 year ]
    Change in triglycerides from baseline to follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03233178


Locations
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Canada, Ontario
LMC Brampton
Brampton, Ontario, Canada, L6S 0C9
Sponsors and Collaborators
LMC Diabetes & Endocrinology Ltd.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: LMC Diabetes & Endocrinology Ltd.
ClinicalTrials.gov Identifier: NCT03233178    
Other Study ID Numbers: ALT
First Posted: July 28, 2017    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases