Diabetes MellitusPhase 4NCT00717288
Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir
A Phase 4 study testing Detemir in people with Diabetes Mellitus, run by Ohio State University at 1 site in United States.
Trial summary
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Detemir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diabetes mellitus
- post-cardiothoracic surgery
- requiring an insulin infusion of at least 1 unit/hour
- Age 18-75
Who cannot join
- Glucocorticoids
- total parenteral nutrition (TPN) or tube feeds
- Pregnancy
- Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
- Expected length of stay less than 48 hours following cessation of the insulin drip
- Patients using subcutaneous insulin pumps
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- Diabetic ketoacidosis
- End-stage renal disease
- End-stage liver disease
- Coma
- Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality
- Unable to give consent in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
Read the detailed description
High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.
- Conditions
- Diabetes Mellitus
- Being tested
- Detemir
- Keywords
- diabetes, hyperglycemia, open heart surgery, cardiothoracic surgery, detemir, insulin infusion, intravenous insulin
- Medical subject headings
- Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DetemirDrug
Also called Levemir
Detemir dosed at 50% of calculated basal insulin infusion requirements
DetemirDrug
Detemir dosed at 65% of calculated basal insulin infusion requirements
DetemirDrug
Detemir dosed at 80% of calculated basal insulin infusion requirements
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily Receives: Drug: Detemir |
| 2 | Active comparator | Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily Receives: Drug: Detemir |
| 3 | Active comparator | Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily Receives: Drug: Detemir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3
Measured: day 2, day 3
Secondary outcomes (2)
Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
Number of patients with hypoglycemia (defined as glucose <65 mg/dl)
Measured: 48 hours
Reversion to Intravenous Insulin for Failure of Glycemic Control
Number of participants who went back on intravenous insulin for failure of glycemic control.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionJun 2010
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 MellitusStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Kathleen Dungan, Ohio State University
- Investigators
- Kathleen M Dungan, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00717288
- Sponsor's protocol ID
- 2007H0210
- Other IDs
- 60016576
- Status last verified
- Aug 2011
- First submitted
- 15 Jul 2008
- Last updated
- 3 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
- ClinicalTrials.gov ID
- NCT00717288
- Acronym / sponsor ID
- 2007H0210
- Conditions
- Diabetes Mellitus
- Keywords
- diabetes, hyperglycemia, open heart surgery, cardiothoracic surgery, detemir, insulin infusion, intravenous insulin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Jul 2008 (estimated)
- Results
- Posted 3 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).
Detailed description
High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: DetemirDetemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily |
| 2 | Active comparator | Drug: DetemirDetemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily |
| 3 | Active comparator | Drug: DetemirDetemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diabetes mellitus
- post-cardiothoracic surgery
- requiring an insulin infusion of at least 1 unit/hour
- Age 18-75
Key exclusion criteria (12 listed)
- Glucocorticoids
- total parenteral nutrition (TPN) or tube feeds
- Pregnancy
- Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected
- Expected length of stay less than 48 hours following cessation of the insulin drip
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 |
|---|---|---|
| DetemirAlso: LevemirDetemir dosed at 50% of calculated basal insulin infusion requirements | Drug | 1 |
| DetemirDetemir dosed at 65% of calculated basal insulin infusion requirements | Drug | 2 |
| DetemirDetemir dosed at 80% of calculated basal insulin infusion requirements | Drug | 3 |
Primary outcome
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
Time frame: day 2, day 3
Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3
2 secondary outcomes
Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
Time frame: 48 hours
Reversion to Intravenous Insulin for Failure of Glycemic Control
Time frame: 72 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- 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 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 Detemir in people with Diabetes Mellitus, run by Ohio State 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 4 inclusion and 12 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 3 Oct 2011. 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. 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 3 Oct 2011). 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?
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 (time frame: day 2, day 3). 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 3 Oct 2011.