Diabetes Mellitus, Type 2Phase 4NCT01970462

Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery

A Phase 4 study testing Sitagliptin in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Kathleen Dungan at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes Mellitus, Type 2, Hyperglycemia
What is being tested?: Sitagliptin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 8 participants
Where: 1 siteUnited States
Study dates: Jan 2014to Aug 2016
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia
AND:
Cardiac Surgery
Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24 hour period (>4 hours apart) and otherwise not requiring basal insulin

Who cannot join

use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours
glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours
left ventricular assist device
percutaneous or laparoscopic surgery
end stage renal disease
end stage liver disease

Show all 13Show fewer

history of pancreatitis
type 1 diabetes
pregnancy
unable to give consent in english
no phone
prisoners
less than 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site

The Ohio State University Wexner Medical Center
Columbus, Ohio, 43203

Other trials in United States

About this study

This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient population due to the effects on hepatic glucose production (a major feature of SH), safety (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and tolerability. The secondary objective of this study is to determine whether the management of patients with persistent insulin requirements following cardiac surgery differs among patients with stress hyperglycemia or mild diabetes.

Conditions: Diabetes Mellitus, Type 2, Hyperglycemia
Being tested: Sitagliptin, Placebo
Medical subject headings: Diabetes Mellitus, Type 2, Hyperglycemia

What participants receive

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

SitagliptinDrug
Also called Januvia
Sitagliptin prior to hospital discharge and 6 weeks following discharge.
PlaceboDrug
Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively

Study groups in NCT01970462
Study group	Role	What they receive
Sitagliptin	Experimental	Patients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge Receives: Drug: Sitagliptin
Placebo	Placebo comparator	Patients will receive placebo prior to discharge and 6 weeks after discharge. Receives: Drug: Placebo

What is being measured

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

Difference in Fasting Glucose
Difference in mean fasting glucose at 6 weeks post-discharge.
Measured: 6 weeks

Timeline

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

Jan 2014Aug 2016

First posted28 Oct 2013 (estimated)
Study startJan 2014
Primary completionAug 2016
Study completionAug 2016

Why it stopped: Recruitment

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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01970462
Sponsor's protocol ID: 2013H0328
Status last verified: May 2018
First submitted: 22 Oct 2013
Last updated: 18 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery
ClinicalTrials.gov ID: NCT01970462
Acronym / sponsor ID: 2013H0328
Conditions: Diabetes Mellitus, Type 2, Hyperglycemia
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment
Enrolment: 8 participants (actual)
Lead sponsor: Kathleen DunganUniversity, hospital or other
Study start: Jan 2014
Primary completion: Aug 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 28 Oct 2013 (estimated)
Results: Posted 17 May 2018

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: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Sitagliptin	Experimental	Drug: SitagliptinPatients will receive Sitagliptin (renally dosed) prior to hospital discharge and 6 weeks following discharge
Placebo	Placebo comparator	Drug: PlaceboPatients will receive placebo prior to discharge and 6 weeks after discharge.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia
AND:
Cardiac Surgery
Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24 hour period (>4 hours apart) and otherwise not requiring basal insulin

Key exclusion criteria (13 listed)

use of pressors, mechanical ventilation, or enteral or parenteral feeding within previous 12 hours
glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the previous 48 hours
left ventricular assist device
percutaneous or laparoscopic surgery
end stage renal 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
SitagliptinAlso: JanuviaSitagliptin prior to hospital discharge and 6 weeks following discharge.	Drug	Sitagliptin
PlaceboPatients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively	Drug	Placebo

Primary outcome

Difference in Fasting Glucose
Time frame: 6 weeks
Difference in mean fasting glucose at 6 weeks post-discharge.

Results and safety

Results posted to the registry on 17 May 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sitagliptin	1	1
Placebo	4	2

Primary outcome: Difference in Fasting Glucose

Time frame: 6 weeks

Population analysed: The study was discontinued early and the group assignment was not available from the pharmacy for 3 subjects. Therefore we are unable to provide group level data for the outcomes. Among the 4 subjects for whom data was available, the fasting 6 week glucose value was 158, 114, 83, 237 mg/dl.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sitagliptin	0 of 1 (0%)	0 of 1 (0%)	Not reported
Placebo	0 of 4 (0%)	0 of 4 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
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.

Kathleen M Dungan, MD, MPH principal investigator

Ohio State 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 Sitagliptin in people with Diabetes Mellitus, Type 2 and Hyperglycemia, run by Kathleen Dungan 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 4 inclusion and 13 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 18 Jun 2018. 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?

Yes. Results are posted in the registry (first posted 17 May 2018). 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?

Difference in Fasting Glucose (time frame: 6 weeks). 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 NCT01970462.

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 18 Jun 2018.