T2DM (Type 2 Diabetes Mellitus)ALTNCT03233178
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
An observational study of T2DM (Type 2 Diabetes Mellitus) and Fatty Liver, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus), Fatty Liver, NAFLD
- What is being tested?
- Non-interventional
- How many people
- 4,000 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Diagnosis of type 1 diabetes
- Patients who switched to one of the study treatments from another medication of the same medication class
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Fatty Liver, NAFLD
- Being tested
- Non-interventional
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventionalOther
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 | Patients initiating SGLT2 inhibitors Receives: Other: Non-interventional | |
| Liraglutide | Patients initiation liraglutide Receives: Other: Non-interventional | |
| Sitagliptin | Patients initiating sitagliptin Receives: Other: Non-interventional | |
| Control Group | Patients who did not initiate any new anti-hyperglycemic treatment Receives: Other: Non-interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Secondary outcomes (6)
Change in Hemoglobin A1c from baseline to follow-up
Change in HbA1c from baseline to follow-up
Measured: 1 year
Change in Fasting Plasma Glucose from baseline to follow-up
Change in Fasting Plasma Glucose from baseline to follow-up
Measured: 1 year
Change in body weight from baseline to follow-up
Change in body weight from baseline to follow-up
Measured: 1 year
Change in Body Mass Index (BMI) from baseline to follow-up
Change in BMI from baseline to follow-up
Measured: 1 year
Change in Waist Circumference (WC) from baseline to follow-up
Change in WC from baseline to follow-up
Measured: 1 year
Change in triglycerides from baseline to follow-up
Change in triglycerides from baseline to follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startJan 2017
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03233178
- Sponsor's protocol ID
- ALT
- Acronym
- ALT
- Status last verified
- Jul 2017
- First submitted
- 20 Jul 2017
- Last updated
- 28 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30149145
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03233178
- Acronym / sponsor ID
- ALT / ALT
- Conditions
- T2DM (Type 2 Diabetes Mellitus), Fatty Liver, NAFLD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- LMC Diabetes & Endocrinology Ltd.University, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SGLT2 | – | Other: Non-interventionalPatients initiating SGLT2 inhibitors |
| Liraglutide | – | Other: Non-interventionalPatients initiation liraglutide |
| Sitagliptin | – | Other: Non-interventionalPatients initiating sitagliptin |
| Control Group | – | Other: Non-interventionalPatients who did not initiate any new anti-hyperglycemic treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Diagnosis of type 1 diabetes
- Patients who switched to one of the study treatments from another medication of the same medication class
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional | Other | Control Group, Liraglutide, SGLT2, Sitagliptin |
Primary outcome
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
6 secondary outcomes
Change in Hemoglobin A1c from baseline to follow-up
Time frame: 1 year
Change in Fasting Plasma Glucose from baseline to follow-up
Time frame: 1 year
Change in body weight from baseline to follow-up
Time frame: 1 year
Change in Body Mass Index (BMI) from baseline to follow-up
Time frame: 1 year
Change in Waist Circumference (WC) from baseline to follow-up
Time frame: 1 year
Change in triglycerides from baseline to follow-up
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2017.
- Derived from this study: PubMed 30149145Bajaj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T2DM (Type 2 Diabetes Mellitus) and Fatty Liver, run by LMC Diabetes & Endocrinology Ltd. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ALT in patients with T2DM initiating SGLT2 inhibitors, Liraglutide or Sitagliptin compared to control (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03233178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2017.