Diabetes MellitusPhase 3NCT00660075

Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes

A Phase 3 study testing Sitagliptin in people with Diabetes Mellitus and Postprandial Lipemia, run by Laval University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Diabetes Mellitus, Postprandial Lipemia
What is being tested?: Sitagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 36 participants
Where: 1 siteCanada
Study dates: Feb 2008to Apr 2009
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
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes as defined by the American Diabetes Association;
Non-smoker;
Body mass index between 25.0 and 40.0 kg/m2;
Baseline 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 week and -4;

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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 TSH 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;
Subjects will be excluded if they have cardiovascular disease (CVD) (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;
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;

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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 AST or ALT >2 x upper limit of the laboratory reference range will be excluded;
Subjects with coagulopathy (prothrombin time [PT] or partial thromboplastin time [PTT] at Visit 1 >1.5 times control;
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 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.

Canada1 site

Laval University Medical Center
Québec, Quebec, G1V 4G2

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Effects of Sitagliptin on Postprandial Plasma Lipoprotein Concentrations in Men With Type 2 Diabetes

Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes mainly through incretin hormone-mediated improvements in islet function. Although clinical studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG) absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the present study was designed to examine the effects of sitagliptin on postprandial lipemia in patients with type 2 diabetes. A possible reduction in postprandial atherogenic triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients with type 2 diabetes.

Conditions: Diabetes Mellitus, Postprandial Lipemia
Being tested: Sitagliptin, Placebo
Keywords: Diabetes mellitus, Postprandial, Hyperlipidemia, Atherosclerosis
Medical subject headings: Diabetes Mellitus, Hyperlipidemias, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SitagliptinDrug
Sitagliptin 100 mg/d for 6 weeks
PlaceboDrug
Placebo for 6 weeks

Study groups in NCT00660075
Study group	Role	What they receive
1	Experimental	Sitagliptin 100 mg/d for 6 weeks Receives: Drug: Sitagliptin
2	Placebo comparator	Placebo for 6 weeks Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)
Measured: At the end of the two 6-week interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Apr 2009

First posted17 Apr 2008 (estimated)
Study startFeb 2008
Primary completionJan 2009
Study completionApr 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for 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: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00660075
Sponsor's protocol ID: SITA001
Status last verified: Nov 2012
First submitted: 14 Apr 2008
Last updated: 11 Dec 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Tremblay AJ, Lamarche B, Deacon CF, Weisnagel SJ, Couture P. Effects of sitagliptin therapy on markers of low-grade inflammation and cell adhesion molecules in patients with type 2 diabetes. Metabolism. 2014 Sep;63(9):1141-8. doi: 10.1016/j.metabol.2014.06.004. Epub 2014 Jun 14.
PubMed 25034387

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Effects of Sitagliptin on Postprandial Plasma Lipoprotein Concentrations in Men With Type 2 Diabetes
ClinicalTrials.gov ID: NCT00660075
Acronym / sponsor ID: SITA001
Conditions: Diabetes Mellitus, Postprandial Lipemia
Keywords: Diabetes mellitus, Postprandial, Hyperlipidemia, Atherosclerosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Laval UniversityUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Feb 2008
Primary completion: Jan 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 17 Apr 2008 (estimated)
Results: Posted 11 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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
1	Experimental	Drug: SitagliptinSitagliptin 100 mg/d for 6 weeks
2	Placebo comparator	Drug: PlaceboPlacebo for 6 weeks

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Type 2 diabetes as defined by the American Diabetes Association;
Non-smoker;
Body mass index between 25.0 and 40.0 kg/m2;
Baseline HbA1c between 6.5 and 8.5%;
Baseline fasting plasma glucose < 15.0 mmol/L;

Key exclusion criteria (16 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;
Subjects will be excluded if they have cardiovascular disease (CVD) (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;

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
SitagliptinSitagliptin 100 mg/d for 6 weeks	Drug	1
PlaceboPlacebo for 6 weeks	Drug	2

Primary outcome

Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)
Time frame: At the end of the two 6-week interventions

Results and safety

Results posted to the registry on 11 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First, Then Sitagliptin	18	18
Sitagliptin First, Then Placebo	18	18

Primary outcome: Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)

Time frame: At the end of the two 6-week interventions. Mean (Standard Deviation). Unit: mmol*h/L

Measure	Placebo n = 36	Sitagliptin 100 mg/d n = 36
Value	30.0 (14.5)	27.1 (13.0)

Population analysed: We analyzed all the subjects involved in the study. The analysis was per protocol. We compared data from the placebo phase with the sitagliptin phase.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	0 of 18 (0%)	0 of 18 (0%)	Not reported
Placebo	0 of 18 (0%)	0 of 18 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25034387Tremblay AJ, Lamarche B, Deacon CF, Weisnagel SJ, Couture P. Effects of sitagliptin therapy on markers of low-grade inflammation and cell adhesion molecules in patients with type 2 diabetes. Metabolism. 2014 Sep;63(9):1141-8. doi: 10.1016/j.metabol.2014.06.004. Epub 2014 Jun 14.

Related trials for Diabetes Mellitus

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
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Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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 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 Diabetes Mellitus and Postprandial Lipemia, 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 10 inclusion and 16 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 11 Dec 2012. 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 11 Dec 2012). 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 the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours) (time frame: At the end of the two 6-week interventions). 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 NCT00660075, 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 11 Dec 2012.