DiabetesPhase 4NCT00309465

Perioperative Insulin Glargine Dosing Study

A Phase 4 study testing Lantus and Insulin in people with Diabetes and Surgery, run by Tamra Dukatz at 2 sites in United States.

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

The main objective of this study is to compare three strategies of evening insulin glargine dosing to preoperative glucose values in patients with diabetes undergoing surgery to determine which dosing strategies most often achieves the admission target study values of 100-179 mg/dl. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Surgery
What is being tested?: Lantus and Insulin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 402 participants
Where: 2 sitesUnited States
Study dates: Oct 2005to Oct 2009
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

Scheduled for Surgical Procedure
Self Management of Diabetes
Currently on Evening Insulin Glargine prescribed by Primary Care Physician
Age 18 or over
Able to Communicate Clearly over the Phone
Pre-screened by Anesthesia Department > 48 hours prior to Surgery

Who cannot join

On Glucocorticoid Medication
On Insulin Glargine Dual Dosing or Sliding Scale Regimen
History of Hypoglycemia Unawareness
Pregnancy or Lactating Female
On Insulin Glargine for < 3 months

Trial locations and contacts

2 sites in 1 country.

United States2 sites

William Beaumont Hospital
Royal Oak, Michigan, 48073
William Beaumont Hospital
Troy, Michigan, 48085

Other trials in United States

About this study

Official title: A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery

Read the detailed description

There are no evidence-based guidelines for insulin glargine (Lantus) dosing in the perioperative setting. Insulin glargine provides peakless 24-hour coverage of basal insulin needs for people with both Type 1 and Type 2 diabetes. Insulin glargine may be used as the sole insulin or in combination with other rapid-acting insulin to achieve glycemic control.

Anesthesia literature recommends that blood sugar values on insulin-dependent patients be maintained between 120-180 mg/dl in most surgeries. Symptoms of low blood sugar are undetectable in anesthetized patients, and blood glucose is tested at least hourly. Since patients are still awake and alert toward hypoglycemic symptoms in the preoperative area, the admission target study values are 100-179 mg/dl. Glucose values greater than 200 mg/dl have been associated with increased rates of infection, and exacerbated complications if a major cardiovascular event happens.

Frequently insulin glargine is administered in the evening. Patients who are scheduled for surgery in the morning are asked not to eat or drink after midnight. Some endocrinology experts recommend that all or part of the patient's usual insulin glargine should be given to avoid high blood sugar; however, whenever insulin is given without food, the possibility of low blood sugar exists.

Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Conditions: Diabetes, Surgery
Being tested: Lantus, Insulin
Keywords: Diabetes, Insulin Glargine, Surgery
Medical subject headings: Diabetes Mellitus

What participants receive

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

LantusDrug
Also called Lantus, Insulin
Patients in Group 1 will administer 80% of their usual insulin glargine dose.
InsulinOther
Also called As directed by regular physician
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose
LantusDrug
Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Study groups in NCT00309465
Study group	Role	What they receive
1	Experimental	Patients in Group 1 will administer 80% of their usual insulin glargine dose. Receives: Drug: Lantus
2	Active comparator	Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose. Receives: Other: Insulin
3	Experimental	Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin. Receives: Drug: Lantus

What is being measured

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

Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.
Measured: Day 1

Timeline

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

Oct 2005Oct 2009

First posted31 Mar 2006 (estimated)
Study startOct 2005
Primary completionOct 2008
Study completionOct 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.
Other trials for DiabetesStudies 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: None (open label)
Enrolment: 402 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00309465
Sponsor's protocol ID: HIC 2005-080
Status last verified: Nov 2012
First submitted: 30 Mar 2006
Last updated: 3 Dec 2012
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 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study of the Relationship Between the Proportional Insulin Glargine Evening Dose and the Perioperative Serum Glucose Values in Patients With Diabetes Undergoing Surgery
ClinicalTrials.gov ID: NCT00309465
Acronym / sponsor ID: HIC 2005-080
Conditions: Diabetes, Surgery
Keywords: Diabetes, Insulin Glargine, Surgery
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Tamra DukatzUniversity, hospital or other
Collaborators: Sanofi
Study start: Oct 2005
Primary completion: Oct 2008 (actual)
Study completion: Oct 2009 (actual)
First posted: 31 Mar 2006 (estimated)
Results: Posted 3 Dec 2012

Clinical summary

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

Detailed description

Patients in Group 1 will administer 80% of their usual insulin glargine dose.
Group 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
Group 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: LantusPatients in Group 1 will administer 80% of their usual insulin glargine dose.
2	Active comparator	Other: InsulinGroup 2 patients will contact their own diabetes care physician and follow those recommendations for the dose.
3	Experimental	Drug: LantusGroup 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.

Who may qualify

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

Key inclusion criteria (6 listed)

Scheduled for Surgical Procedure
Self Management of Diabetes
Currently on Evening Insulin Glargine prescribed by Primary Care Physician
Age 18 or over
Able to Communicate Clearly over the Phone

Key exclusion criteria (5 listed)

On Glucocorticoid Medication
On Insulin Glargine Dual Dosing or Sliding Scale Regimen
History of Hypoglycemia Unawareness
Pregnancy or Lactating Female
On Insulin Glargine for < 3 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
LantusAlso: Lantus, InsulinPatients in Group 1 will administer 80% of their usual insulin glargine dose.	Drug	1
InsulinAlso: As directed by regular physicianGroup 2 patients will contact their own diabetes care physician and follow those recommendations for the dose	Other	2
LantusGroup 3 patients will take 50%, 80%, or 100% of their usual insulin glargine dose. Which of those three percentages will be determined by the midpoint of the patient's usual self-reported fasting blood sugar (FBS) range and whether the patients is also taking a rapid-acting insulin.	Drug	3

Primary outcome

Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
Time frame: Day 1
Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.

Results and safety

Results posted to the registry on 3 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
Take 80% (Insulin Glargine Only Group)	58	58
Call Physician (Insulin Glargine Only Group)	58	58
Dose Table (Insulin Glargine Only Group)	58	58
Take 80% (Insulin Glargine Plus Bolus Group)	76	75
Call Physician (Insulin Glargine Plus Bolus Group	76	76
Dose Table (Insulin Glargine Plus Bolus Group)	76	76

Primary outcome: Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery

Time frame: Day 1. Number. Unit: Percentage of subjects

Measure	Take 80% (Insulin Glargine Only Group) n = 58	Call Physician (Insulin Glargine Only Group) n = 58	Dose Table (Insulin Glargine Only Group) n = 58	Take 80% (Insulin Glargine Plus Bolus Group) n = 75	Call Physician (Insulin Glargine Plus Bolus Group n = 76	Dose Table (Insulin Glargine Plus Bolus Group) n = 76
Achievement of 100-179 mg/dl	58.6	72.4	74.1	58.7	52.6	63.2
Achievement of 80-249 mg/dl	89.7	89.7	98.3	81.3	81.6	93.4

Take 80% (Insulin Glargine Only Group) vs Call Physician (Insulin Glargine Only Group) vs Dose Table (Insulin Glargine Only Group): p = 0.332, Chi-squared
Take 80% (Insulin Glargine Plus Bolus Group) vs Call Physician (Insulin Glargine Plus Bolus Group vs Dose Table (Insulin Glargine Plus Bolus Group): p = 0.294, Chi-squared
Take 80% (Insulin Glargine Only Group) vs Call Physician (Insulin Glargine Only Group) vs Dose Table (Insulin Glargine Only Group): p = 0.162, Chi-squared

Population analysed: Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat.

Adverse events

Time frame: Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Take 80% (Insulin Glargine Only Group)	0 of 58 (0%)	1 of 58 (1.7%)	Not reported
Call Physician (Insulin Glargine Only Group)	1 of 58 (1.7%)	0 of 58 (0%)	Not reported
Dose Table (Insulin Glargine Only Group)	0 of 58 (0%)	0 of 58 (0%)	Not reported
Take 80% (Insuling Glargine Plus Bolus Group)	0 of 75 (0%)	1 of 75 (1.3%)	Not reported
Call Physician (Insulin Glargine Plus Bolus Group)	0 of 76 (0%)	0 of 76 (0%)	Not reported
Dose Table (Insulin Glargine Plus Bolus Group)	0 of 76 (0%)	1 of 76 (1.3%)	Not reported

Limitations and caveats (from the sponsor): Limitations include use of point-of-care glucometers, which are less precise than central laboratory testing; estimated 75% power in the insulin glargine only group; and varying fasting lengths, usual glycemic control and surgery starting times.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2012.
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.

Tamra Dukatz, MSN, CRNA principal investigator

Corewell Health East

2 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 Lantus and Insulin in people with Diabetes and Surgery, run by Tamra Dukatz at 2 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 6 inclusion and 5 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 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 2 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. 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 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?

Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery (time frame: Day 1). 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 NCT00309465.

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 Dec 2012.