Type 2 Diabetes MellitusPhase 3NCT02536248
Sitagliptin Therapy and Kinetics of Inflammatory Markers
A Phase 3 study testing Sitagliptin in people with Type 2 Diabetes Mellitus, run by Laval University at 1 site in Canada.
Trial summary
Inflammatory processes are increasingly being recognized as a critical step in the pathogenesis of both diabetes and heart disease and may constitute a biological link between the two diseases. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Sitagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2015to 31 Oct 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males 18 to 65 years of age.
- Post-menopausal women under age 65 on stable medical therapy for 6 months before the study (the patient should have demonstrated stable lipid panels)
- Women should not be on hormone replacement therapy (no recent starting or stopping)
- Type 2 diabetes as defined by the American Diabetes Association.
- Non-smoker.
- Body mass index between 25.0 and 40.0 kg/m2.
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- Baseline glycated hemoglobin A1c (HbA1c) between 6.5 and 8.5%.
- Baseline fasting plasma glucose < 15.0 mmol/L.
- Plasma triglyceride levels between 1.5 and 8.0 mmol/L (135 and 710 mg/dl) at screening and week -4.
- Patients having received stable doses of metformin for at least 3 months before randomization.
- Subjects must be willing to give written informed consent and able to adhere to dosing schedule, visit schedule and phone follow-up assessment.
- Patients should be otherwise generally healthy, without elevations in hepatic transaminases or abnormal renal function or coagulation.
- Patients having normal thyroid stimulating hormone at screening
Who cannot join
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
- Patients with type 1 diabetes, secondary form of diabetes or acute metabolic diabetic complications will be excluded.
- Patients having received or being treated with insulin or a thiazolidinedione within the past 6 months will be excluded.
- Patients taking any other hypoglycemic agent, other than metformin.
- Subjects will be excluded if they have cardiovascular disease (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents, significant alcohol intake etc.).
- Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
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- Individuals with a history of mental instability, drug or alcohol abuse or individuals who have been treated or are being treated for severe psychiatric illness that, in the opinion of the investigator, may interfere with optimal participation in the study.
- History of alcohol or drug abuse within the past 2 years. Patients must not take alcohol during the study.
- Disorders of the hematologic, digestive, or central nervous systems, including cerebrovascular disease and degenerative disease, that would limit study evaluation or participation.
- Known impairment of renal function (serum creatinine levels > 1.7 mg/dL for men), dysproteinemia, nephrotic syndrome, or other renal disease (24-hour urinary protein ≥3 ± 1 g).
- Active or chronic hepatobiliary or hepatic disease. In addition, patients with aspartate aminotransferase or alanine aminotransferase >2 x upper limit of the laboratory reference range will be excluded.
- Subjects with coagulopathy (prothrombin time or partial thromboplastin time at Visit 1 >1.5 times control).
- Subjects with hemoglobin >2 x the lower limit of the laboratory reference range will be excluded.
- Patients who are known to have tested positive for human immunodeficiency virus (HIV).
- Patients who are currently enrolled in another clinical study.
- Patients who have used any investigational drug within 30 days of the first clinic visit.
- Congestive heart failure New York Heart Association (NYHA) Class III or IV. Uncontrolled cardiac arrhythmias within 3 months of study entry.
- Uncontrolled diabetes mellitus (HbA1c>8.5%) or other endocrine or metabolic disease known to influence serum lipids or lipoproteins. Clinically euthyroid subjects on replacement doses of thyroid hormone are eligible for enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECTS OF SITAGLIPTIN THERAPY ON THE KINETICS OF MARKERS OF LOW-GRADE INFLAMMATION AND CELL ADHESION MOLECULES IN PATIENTS WITH TYPE 2 DIABETES
Inflammatory processes are increasingly being recognized as a critical step in the pathogenesis of both diabetes and heart disease and may constitute a biological link between the two diseases. Inflammatory cytokines increase vascular permeability, change vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important step in the development of atherosclerosis, and adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore, identifying novel therapeutic approaches that would favorably affect inflammation, endothelial function, and glucose is of significant interest. Investigators have recently demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The results also suggest that the beneficial effects of sitagliptin on both inflammation and endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the beneficial effects of sitagliptin on these markers remain to be fully elucidated. The proposed study will address this key issue.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Sitagliptin, Placebo
- Keywords
- sitagliptin, diabetes, inflammation
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SitagliptinDrug
Also called Januvia
Sitagliptin 100 mg/d for 6 weeks
PlaceboDrug
Placebo for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sitagliptin first, then Placebo | Experimental | Sitagliptin 100 mg/d for 6 weeks
Wash-out 14 days
Placebo for 6 weeks Receives: Drug: Sitagliptin; Drug: Placebo |
| Placebo first, then Sitagliptin | Placebo comparator | Placebo for 6 weeks
Wash-out 14 days
Sitagliptin 100 mg/d for 6 weeks Receives: Drug: Sitagliptin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of C-reactive Protein Production Rate With Stable Isotope During Postprandial Period
Measured: 6 weeks
Secondary outcomes (3)
Measurement of Serum Amyloid A Production Rate With Stable Isotope During Postprandial Period
Measured: 6 weeks
Measurement of L-selectin Production Rate With Stable Isotope During Postprandial Period
Measured: 6 weeks
Measurement of ICAM-1 Production Rate With Stable Isotope During Postprandial Period
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study start1 Aug 2015
- Primary completion30 Sep 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Patrick Couture, Laval University
- Investigators
- Patrick Couture, MD, PhD, FRCP, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536248
- Sponsor's protocol ID
- JANU-INF
- Status last verified
- Apr 2020
- First submitted
- 27 Aug 2015
- Last updated
- 13 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF SITAGLIPTIN THERAPY ON THE KINETICS OF MARKERS OF LOW-GRADE INFLAMMATION AND CELL ADHESION MOLECULES IN PATIENTS WITH TYPE 2 DIABETES
- ClinicalTrials.gov ID
- NCT02536248
- Acronym / sponsor ID
- JANU-INF
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- sitagliptin, diabetes, inflammation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 13 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Inflammatory processes are increasingly being recognized as a critical step in the pathogenesis of both diabetes and heart disease and may constitute a biological link between the two diseases. Inflammatory cytokines increase vascular permeability, change vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important step in the development of atherosclerosis, and adhesion molecules, such as intercellular adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore, identifying novel therapeutic approaches that would favorably affect inflammation, endothelial function, and glucose is of significant interest. Investigators have recently demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The results also suggest that the beneficial effects of sitagliptin on both inflammation and endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the beneficial effects of sitagliptin on these markers remain to be fully elucidated. The proposed study will address this key issue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sitagliptin first, then Placebo | Experimental | Drug: Sitagliptin, Drug: PlaceboSitagliptin 100 mg/d for 6 weeks Wash-out 14 days Placebo for 6 weeks |
| Placebo first, then Sitagliptin | Placebo comparator | Drug: Sitagliptin, Drug: PlaceboPlacebo for 6 weeks Wash-out 14 days Sitagliptin 100 mg/d for 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Males 18 to 65 years of age.
- Post-menopausal women under age 65 on stable medical therapy for 6 months before the study (the patient should have demonstrated stable lipid panels)
- Women should not be on hormone replacement therapy (no recent starting or stopping)
- Type 2 diabetes as defined by the American Diabetes Association.
- Non-smoker.
Key exclusion criteria (18 listed)
- Patients with extreme dyslipidemias, such as familial hypercholesterolemia will be excluded.
- Patients with type 1 diabetes, secondary form of diabetes or acute metabolic diabetic complications will be excluded.
- Patients having received or being treated with insulin or a thiazolidinedione within the past 6 months will be excluded.
- Patients taking any other hypoglycemic agent, other than metformin.
- Subjects will be excluded if they have cardiovascular disease (coronary heart disease, cerebrovascular disease or peripheral arterial disease) or if they are taking other medications known to affect lipoprotein metabolism (e.g. steroids, beta blockers, thiazide diuretics, lipid lowering agents, significant alcohol intake etc.).
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 |
|---|---|---|
| SitagliptinAlso: JanuviaSitagliptin 100 mg/d for 6 weeks | Drug | Placebo first, then Sitagliptin, Sitagliptin first, then Placebo |
| PlaceboPlacebo for 6 weeks | Drug | Placebo first, then Sitagliptin, Sitagliptin first, then Placebo |
Primary outcome
Measurement of C-reactive Protein Production Rate With Stable Isotope During Postprandial Period
Time frame: 6 weeks
3 secondary outcomes
Measurement of Serum Amyloid A Production Rate With Stable Isotope During Postprandial Period
Time frame: 6 weeks
Measurement of L-selectin Production Rate With Stable Isotope During Postprandial Period
Time frame: 6 weeks
Measurement of ICAM-1 Production Rate With Stable Isotope During Postprandial Period
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Patrick Couture, MD, PhD, FRCP principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sitagliptin in people with Type 2 Diabetes Mellitus, run by Laval University 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 13 inclusion and 18 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 13 May 2020. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Measurement of C-reactive Protein Production Rate With Stable Isotope During Postprandial Period (time frame: 6 weeks). 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 13 May 2020.