Type 2 DiabetesNCT01260246
Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes
A study testing sitagliptin in people with Type 2 Diabetes and Nonalcoholic Steatohepatitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Type 2 Diabetes, Nonalcoholic Steatohepatitis
- What is being tested?
- sitagliptin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Apr 2015
- Phase
- Interventional
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known DM2 (receiving lifestyle management and/or metformin and/or sulfonylurea
- Stable therapy for DM2 for the past 3 months
- All other medications and doses stable for past 3 months
- HbA1c 8.9% or lower (can be done in past 30 days)
- Known NASH based on the accepted American Gastroenterological Association Criteria:
- Alcohol consumption (< 10g/day in women and <20g/day in men)
- Cause of liver disease other than NAFLD (negative investigations for: viral hepatitis, iron overload, a-1 antitrypsin, ceruloplasmin, autoimmune disease)
- Liver histology demonstrating macrovesicular fatty change of hepatocytes, with evidence of steatohepatitis, manifested by the presence of Mallory Bodies, ballooning degeneration, lobular neutrophilic inflammation and perisinusoidal fibrosis. (If liver biopsy done within 2 years prior to screening for this trial, that biopsy will be reviewed to ensure it meets criteria for diagnosis).
Who cannot join
- Any contraindication for undergoing MRI
- Child class B or C cirrhosis
- Participation in another clinical trial
- Use of thiazoledinedione (rosiglitazone or pioglitazone) in past 6 months
- Current use of plavix
- Previous exposure to sitagliptin
Show all 15Show fewer
- Prior history of pancreatitis
- History of anaphylaxis to another Canadian-marketed DPP-IV inhibitor (saxagliptin)
- Creatine clearance <30 ml/min
- Anaemia (haemoglobin < 110 mg/dL)
- Platelet count < 50 000 cells/mm3
- Known heart or kidney failure
- Comorbid condition that decreases natural life span (e.g. known cancer)
- Pregnant or breastfeeding or wishing to become pregnant in the next 6 months
- Current or past treatment with medications that can induce steatohepatitis (e.g. glucocorticoids, methotrexate, amiodarone etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes.
This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of sitagliptin on other measures such as hormones modifying insulin release and sensitivity (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be evaluated.
- Conditions
- Type 2 Diabetes, Nonalcoholic Steatohepatitis
- Being tested
- sitagliptin, placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sitagliptinDrug
pill, 100mg/daily for 6 months
placeboDrug
placebo match for 6 months
| Study group | Role | What they receive |
|---|---|---|
| sitagliptin | Experimental | sitagliptin 100mg/daily for 6 months Receives: Drug: sitagliptin |
| placebo | Placebo comparator | placebo match for 6 months Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.
Measured: 3 years
Secondary outcomes (3)
In individuals with NASH and DM2: To document the impact of sitagliptin therapy on adipocytokines, inflammatory markers, non-traditional cardiovascular risk factors, adipose distribution, and dyslipidemia.
Measured: 3 years
In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress.
Measured: 3 years
In individuals with NASH and DM2: To determine the correlation between changes in histology with changes in hepatic fat demonstrated by MRI and changes in fibrosis by Fibroscan.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Responsible party
- Principal investigator, Tisha Joy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Tisha Joy, MD, Principal investigator, St. Joseph's Health Care, UWO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01260246
- Sponsor's protocol ID
- R-10-533
- Other IDs
- 17389
- Status last verified
- Mar 2017
- First submitted
- 13 Dec 2010
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT01260246
- Acronym / sponsor ID
- R-10-533
- Conditions
- Type 2 Diabetes, Nonalcoholic Steatohepatitis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation
- Study start
- Dec 2010
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Dec 2010 (estimated)
- 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.
This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of sitagliptin on other measures such as hormones modifying insulin release and sensitivity (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sitagliptin | Experimental | Drug: sitagliptinsitagliptin 100mg/daily for 6 months |
| placebo | Placebo comparator | Drug: placeboplacebo match for 6 months |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Known DM2 (receiving lifestyle management and/or metformin and/or sulfonylurea
- Stable therapy for DM2 for the past 3 months
- All other medications and doses stable for past 3 months
- HbA1c 8.9% or lower (can be done in past 30 days)
- Known NASH based on the accepted American Gastroenterological Association Criteria:
Key exclusion criteria (15 listed)
- Any contraindication for undergoing MRI
- Child class B or C cirrhosis
- Participation in another clinical trial
- Use of thiazoledinedione (rosiglitazone or pioglitazone) in past 6 months
- Current use of plavix
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 |
|---|---|---|
| sitagliptinpill, 100mg/daily for 6 months | Drug | sitagliptin |
| placeboplacebo match for 6 months | Drug | placebo |
Primary outcome
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin.
Time frame: 3 years
3 secondary outcomes
In individuals with NASH and DM2: To document the impact of sitagliptin therapy on adipocytokines, inflammatory markers, non-traditional cardiovascular risk factors, adipose distribution, and dyslipidemia.
Time frame: 3 years
In individuals with NASH and DM2: To delineate the effect of sitagliptin therapy on platelet aggregation and oxidative stress.
Time frame: 3 years
In individuals with NASH and DM2: To determine the correlation between changes in histology with changes in hepatic fat demonstrated by MRI and changes in fibrosis by Fibroscan.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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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.
Tisha Joy, MD principal investigator
St. Joseph's Health Care, UWO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sitagliptin in people with Type 2 Diabetes and Nonalcoholic Steatohepatitis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 8 inclusion and 15 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: stopped early, as of the sponsor's last update on 14 Mar 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
To demonstrate improvement in liver disease (based on liver biopsy)with sitagliptin. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2017.