Type 2 Diabetes MellitusPhase 4MAPSSNCT01765270
Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery
A Phase 4 study testing Saxagliptin in people with Type 2 Diabetes Mellitus and Cardiovascular Disease, run by Duke University at 10 sites in United States.
Trial summary
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Cardiovascular Disease
- What is being tested?
- Saxagliptin
- 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
- 10 sitesUnited States
- Study dates
- Mar 2013to Jun 2014
- Phase
- Phase 4
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.
- Stable doses of oral antihyperglycemic agents for at least 2 months
- Stable dose of chronic insulin therapy for at least 2 months
- HbA1c documented within 3 months before study enrollment
- Planned first elective coronary artery bypass graft (CABG) surgery
Who cannot join
- Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
- Receiving incretin therapy or having received incretin therapy within the previous 2 months
- Type 1 DM or a history of ketoacidosis
- Women who are pregnant or breastfeeding
- Known end-stage Kidney disease
- Known sensitivity or intolerance to saxagliptin or dipeptidyl peptidase-4 (DPP-4) inhibitor
- Clinically apparent liver disease
- History of pancreatitis
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Cardiology, PC
Birmingham, Alabama, 35211
Cardio-Thoracic Surgeons PC
Birmingham, Alabama, 35243
Charleston Area Medical Center (CAMC)
Charleston, West Virginia, 25304
Duke University Medical Center (DUMC)
Durham, North Carolina, 27710
Sparks Regional Medical Center
Fort Smith, Arkansas, 72901
Heart Center Research, LLC
Huntsville, Alabama, 35801
Arkansas Cardiology, PA
Little Rock, Arkansas, 72205
Stanford University Medical Center
Palo Alto, California, 94304
Chippenham Medical Center
Richmond, Virginia, 23225
About this study
Official title: Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery. The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).
Read the detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes. Approximately 74 subjects will be randomized and complete the study.
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease
- Being tested
- Saxagliptin, Placebo
- Keywords
- Diabetes, Diabetes Mellitus, Type 2 Diabetes, Cardiovascular Disease, Coronary Artery Bypass Surgery
- Medical subject headings
- Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SaxagliptinDrug
Also called Onglyza
one 5-mg saxagliptin tablet daily
PlaceboDrug
5mg placebo tablet daily
| Study group | Role | What they receive |
|---|---|---|
| Saxagliptin | Active comparator | Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery. Receives: Drug: Saxagliptin |
| Placebo | Placebo comparator | Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Troponin I (TnI) Area Under the Curve (AUC)
Measured: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Secondary outcomes (7)
High Sensitive Troponin-I (hsTnT) Area Under the Curve
Measured: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve
Measured: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Number of Major Adverse Cardiac Events (MACE)
Death, myocardial infarction (MI), or New congestive heart failure (CHF)
Measured: Baseline to end of study (Approximately 35-37 days)
Duration of Inotropic Support
Measured: CABG surg until hosp discharge (Approximately 5 days)
Number of Participants Who Had an Episode of Hypoglycemia
Measured: baseline to end of study (Approximately 35-37 days)
Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support
Measured: CABG to hospital discharge (Approximately 5 days)
Need for Antiarrhythmic Therapy
Measured: CABG surg to hospital discharge Approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2014
- Study completionJun 2014
Why it stopped: The study was stopped due to poor enrollment.
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 Duke 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- L. Kristin Newby, M.D., MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01765270
- Sponsor's protocol ID
- Pro00041744
- Acronym
- MAPSS
- Status last verified
- Apr 2015
- First submitted
- 4 Jan 2013
- Last updated
- 29 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Assessment of the Properties of Saxagliptin in Subjects Undergoing Coronary Artery Bypass Graft Surgery: a Randomized, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01765270
- Acronym / sponsor ID
- MAPSS / Pro00041744
- Conditions
- Type 2 Diabetes Mellitus, Cardiovascular Disease
- Keywords
- Diabetes, Diabetes Mellitus, Type 2 Diabetes, Cardiovascular Disease, Coronary Artery Bypass Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to poor enrollment.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 10 Jan 2013 (estimated)
- Results
- Posted 8 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Individuals with type 2 diabetes mellitus (T2DM) are at increased risk for cardiovascular events (for example, heart attack) and the risk is related to one's overall control of blood glucose levels. In this study the investigators will measure the effects of saxagliptin, compared to placebo, before, during, and after coronary artery bypass graft (CABG) surgery. The investigators will use samples of the patients' blood and tissue to measure and evaluate indicators of the body's response to the treatment. This study is being done to evaluate the effect of saxagliptin on biomarkers of the heart to help us understand whether reducing or controlling a person's blood glucose levels during and after CABG surgery will produce better clinical outcomes (for example, better heart health).
Detailed description
This study is a randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of saxagliptin on cardiac biomarkers of myocardial necrosis, cardiac function, inflammation, and apoptosis in subjects with Type 2 diabetes mellitus (T2DM) undergoing CABG surgery (on pump, via a median sternotomy approach) as an integrated measure of the potential mechanistic effects of saxagliptin on prevention of cardiovascular (CV) outcomes. Approximately 74 subjects will be randomized and complete the study.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saxagliptin | Active comparator | Drug: SaxagliptinTreatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery. |
| Placebo | Placebo comparator | Drug: PlaceboTreatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Known diagnosis of type 2 diabetes mellitus (T2DM) with glycosylated hemoglobin (HbA1c) between 6.5% and 10%, inclusive.
- Planned first elective coronary artery bypass graft (CABG) surgery
Key exclusion criteria (8 listed)
- Elevated Creatine Kinase-Myocardial Bands (CK-MB) or troponin level above the 99th percentile at screening
- Receiving incretin therapy or having received incretin therapy within the previous 2 months
- Type 1 DM or a history of ketoacidosis
- Women who are pregnant or breastfeeding
- Known end-stage Kidney disease
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: Onglyzaone 5-mg saxagliptin tablet daily | Drug | Saxagliptin |
| Placebo5mg placebo tablet daily | Drug | Placebo |
Primary outcome
Troponin I (TnI) Area Under the Curve (AUC)
Time frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
7 secondary outcomes
High Sensitive Troponin-I (hsTnT) Area Under the Curve
Time frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Creatine Kinase-Myocardial Bands (CK-MB) Area Under the Curve
Time frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)
Number of Major Adverse Cardiac Events (MACE)
Time frame: Baseline to end of study (Approximately 35-37 days)
Duration of Inotropic Support
Time frame: CABG surg until hosp discharge (Approximately 5 days)
Number of Participants Who Had an Episode of Hypoglycemia
Time frame: baseline to end of study (Approximately 35-37 days)
Number of Participants Who Required Intraaortic Balloon Pump (IABP) Support
Time frame: CABG to hospital discharge (Approximately 5 days)
Need for Antiarrhythmic Therapy
Time frame: CABG surg to hospital discharge Approximately 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2015.
- 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.
L. Kristin Newby, M.D., MHS principal investigator
Duke University
10 sites 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 Mellitus and Cardiovascular Disease, run by Duke University at 10 sites 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 5 inclusion and 8 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 29 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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?
Yes. Results are posted in the registry (first posted 8 May 2015). 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?
Troponin I (TnI) Area Under the Curve (AUC) (time frame: pre-CABG surgery (after 5 to 7 days of assigned treatment, predischarge or 5 days post-CABG surgery (Approximately 12 days)). 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 29 May 2015.