Type 2 DiabetesPhase 4NCT01527747
Effects of DPP-4 Inhibition on Triglycerides
A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes and Hypertriglyceridemia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on fasting and post-meal blood triglyceride (blood fat) levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Hypertriglyceridemia
- What is being tested?
- Saxagliptin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Dec 2024
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to provide signed written informed consent
- Men and women aged 18-80 years
- Type 2 diabetes (as defined by the ADA - see reference 18)
- Baseline HgbA1c between 6.5% and 8%; HgbA1c 7.5-8.0% among subjects taking sulfonylureas
- Baseline plasma triglyceride concentration between 200 and 700 mg/dl
- Stable diabetes medication regimen for at least 12 weeks prior to study entry
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- Taking a statin for at least 8 weeks, unless statin therapy is contraindicated or intolerable
- Treatment with other lipid-lowering medications only if the dose has been stable for > 8 weeks.
- Non-smoker
- Body mass index < 45.0 kg/m2
- BP < 140/85
- Normal serum TSH and free T4 concentrations (hypothyroid subjects taking a stable replacement dose of levothyroxine will be allowed if they are biochemically euthyroid)
- Subjects will otherwise be healthy
- Women of child-bearing potential must be willing to use reliable contraception, as defined by our IRB, throughout the study (There are currently no FDA recommended restrictions on the use of saxagliptin in sexually active men, or requirements for contraception in their wives or sexual partners)
- Able and willing to complete study procedures
Who cannot join
- Transaminase concentrations > 2 times the ULN. (Mild elevations of AST and ALT will be allowed up to 2x ULN at baseline if there is no evidence of viral hepatitis or intrinsic liver disease. Since many of these subjects may have some degree of hepatic steatosis, a key intervention is the implementation of treatment to lower glucose and triglycerides)
- Estimated creatinine clearance < 60 ml/min
- Microalbumin-creatinine ratio > 120
- Alcohol consumption > 1 drink daily in women and > 2 drinks daily in men
- Pancreatitis within the preceding 6 months
- Type 1 diabetes
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- History of diabetic ketoacidosis (DKA)
- Cardiovascular disease (CAD, stroke, PVD)
- Known human immunodeficiency virus (HIV) infection
- Viral hepatitis
- Pregnancy or lactation
- A current diagnosis of active non-dermatologic cancer
- Other life-threatening illness
- History of small bowel resection or gastric bypass surgery
- Use of glucocorticoid medications, beta blockers, thiazide diuretics, excess alcohol intake (beta-blockers and thiazide diuretic will be allowed, if necessary, if the dose has been stable for > 12 weeks prior to study entry and the dose will remain stable throughout the study. Complete exclusion of these drugs would exclude a substantial proportion of diabetic patients)
- Use of systemic cytochrome P450 3A4 (CYP 3A4/5) inhibitors such as ketaconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir and telithromycin.
- Current enrollment in another research study or use of any investigational drug within 90 days of study entry
- Other medical conditions that may interfere with participation in the study, in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations
The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on fasting and post-meal blood triglyceride (blood fat) levels.
Read the detailed description
This study is designed to help us understand the effects of DPP-4 inhibition on triglyceride levels before and after eating.
- Conditions
- Type 2 Diabetes, Hypertriglyceridemia
- Being tested
- Saxagliptin
- Keywords
- Type 2 Diabetes, Hypertriglyceridemia, dipeptidyl peptidase-4 (DPP-4), glucagon-like peptide-1 (glp-1)
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxagliptinDrug
Also called Onglyza
5 mg daily
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo arm Receives: Drug: Saxagliptin |
| Saxagliptin | Experimental | Active drug arm Receives: Drug: Saxagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting and postprandial triglyceride concentrations
Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin
Measured: baseline, 6 weeks
Secondary outcomes (1)
Changes in glycemia
Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin
Measured: baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionNov 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: Funding
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 Oregon Health and Science 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P. Barton Duell, M.D., Oregon Health and Science University
- Investigators
- P Barton Duell, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01527747
- Sponsor's protocol ID
- CV181-142
- Status last verified
- Apr 2023
- First submitted
- 31 Jan 2012
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dipeptidyl Peptidase-4 Inhibition With Saxagliptin on Fasting and Postprandial Triglyceride Concentrations
- ClinicalTrials.gov ID
- NCT01527747
- Acronym / sponsor ID
- CV181-142
- Conditions
- Type 2 Diabetes, Hypertriglyceridemia
- Keywords
- Type 2 Diabetes, Hypertriglyceridemia, dipeptidyl peptidase-4 (DPP-4), glucagon-like peptide-1 (glp-1)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 7 Feb 2012 (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.
The purpose of this study is to test the effects of saxagliptin, a treatment for diabetes, on fasting and post-meal blood triglyceride (blood fat) levels.
Detailed description
This study is designed to help us understand the effects of DPP-4 inhibition on triglyceride levels before and after eating.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SaxagliptinPlacebo arm |
| Saxagliptin | Experimental | Drug: SaxagliptinActive drug arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Willing to provide signed written informed consent
- Men and women aged 18-80 years
- Type 2 diabetes (as defined by the ADA - see reference 18)
- Baseline HgbA1c between 6.5% and 8%; HgbA1c 7.5-8.0% among subjects taking sulfonylureas
- Baseline plasma triglyceride concentration between 200 and 700 mg/dl
Key exclusion criteria (18 listed)
- Transaminase concentrations > 2 times the ULN. (Mild elevations of AST and ALT will be allowed up to 2x ULN at baseline if there is no evidence of viral hepatitis or intrinsic liver disease. Since many of these subjects may have some degree of hepatic steatosis, a key intervention is the implementation of treatment to lower glucose and triglycerides)
- Estimated creatinine clearance < 60 ml/min
- Microalbumin-creatinine ratio > 120
- Alcohol consumption > 1 drink daily in women and > 2 drinks daily in men
- Pancreatitis within the preceding 6 months
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 |
|---|---|---|
| SaxagliptinAlso: Onglyza5 mg daily | Drug | Placebo, Saxagliptin |
Primary outcome
Change in fasting and postprandial triglyceride concentrations
Time frame: baseline, 6 weeks
Comparison of 6 weeks of placebo vs 6 weeks of saxagliptin
1 secondary outcome
Changes in glycemia
Time frame: baseline, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- 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.
P Barton Duell, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes and Hypertriglyceridemia, run by Oregon Health and Science University at 1 site in United States.
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 15 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: paused, as of the sponsor's last update on 7 Apr 2023. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Change in fasting and postprandial triglyceride concentrations (time frame: baseline, 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 7 Apr 2023.