NCT03233178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2017

Completed
Last Updated

July 28, 2017

Status Verified

July 1, 2017

Enrollment Period

5 months

First QC Date

July 20, 2017

Last Update Submit

July 27, 2017

Conditions

T2DM (Type 2 Diabetes Mellitus)Fatty LiverNAFLD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in Hemoglobin A1c from baseline to follow-up

    1 year

  • Change in Fasting Plasma Glucose from baseline to follow-up

    1 year

  • Change in body weight from baseline to follow-up

    1 year

  • Change in Body Mass Index (BMI) from baseline to follow-up

    1 year

  • Change in Waist Circumference (WC) from baseline to follow-up

    1 year

  • +1 more secondary outcomes

Study Arms (4)

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

Interventions

Non-interventionalOTHER
Control GroupLiraglutideSGLT2Sitagliptin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LMC Brampton

Brampton, Ontario, L6S 0C9, Canada

Location

Related Publications (1)

  • 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.

    PMID: 30149145DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Fatty LiverNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2017

First Posted

July 28, 2017

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 28, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)