HyperglycemiaPhase 4NCT00338104
Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
A Phase 4 study testing insulin glargine in people with Hyperglycemia and Diabetes, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperglycemia, Diabetes
- What is being tested?
- insulin glargine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2004to May 2005
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fasting glucose > 100 mg/dl
- Patients on surgical services or in intensive care units receiving intravenous insulin
Who cannot join
- Inability to obtain informed consent from patient or next-of-kin
- Allergy to insulin
- Participation in another research study
- Patients for whom there are "do-not-resuscitate" orders
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design.
Note: Lantus insulin is the proprietary name for glargine insulin.
Read the detailed description
Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart.
Subjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows:
- Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;
- Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;
- Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion.
The glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.
- Conditions
- Hyperglycemia, Diabetes
- Being tested
- insulin glargine
- Keywords
- insulin, glargine, intravenous, subcutaneous, hospital, diabetes, glucose, inpatient
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glargineDrug
Also called Lantus is brand name for Glargine
Insulin glargine given at 40% of prior stable drip rate.
insulin glargineDrug
Also called Lantus is brand name for Glargine
Insulin glargine given at 60% of prior stable drip rate.
insulin glargineDrug
Also called Lantus is brand name for Glargine
Insulin glargine given at 80% of prior stable drip rate.
| Study group | Role | What they receive |
|---|---|---|
| 40% Glargine | Experimental | Patients will receive a dose of glargine insulin equal to 40% of insulin drip rate. Receives: Drug: insulin glargine |
| 60% Glargine | Experimental | Patients will receive a dose of glargine insulin equal to 60% of insulin drip rate. Receives: Drug: insulin glargine |
| 80% Glargine | Experimental | Patients will receive a dose of glargine insulin equal to 80% of insulin drip rate. Receives: Drug: insulin glargine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Blood Glucose Values Between 80 - 140
Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL
Measured: First 24 hours after conversion
Secondary outcomes (2)
Percentage of Glucose Values < 50 mg/dL
Percentage of blood glucose values < 50 mg/dL
Measured: First 24 hours after conversion
Percentage of Glucose Levels > 180 mg/dL
Percentage of blood glucose levels > 180 mg/dL
Measured: First 24 hours after conversion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2006 (estimated)
- Study startJul 2004
- Primary completionMay 2005
- Study completionMay 2005
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Northwestern 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
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Investigators
- Mark E Molitch, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00338104
- Sponsor's protocol ID
- 0361-028
- Status last verified
- Mar 2009
- First submitted
- 15 Jun 2006
- Last updated
- 6 Apr 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Schmeltz LR, DeSantis AJ, Schmidt K, O'Shea-Mahler E, Rhee C, Brandt S, Peterson S, Molitch ME. Conversion of intravenous insulin infusions to subcutaneously administered insulin glargine in patients with hyperglycemia. Endocr Pract. 2006 Nov-Dec;12(6):641-50. doi: 10.4158/EP.12.6.641.
PubMed 17229660
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin
- ClinicalTrials.gov ID
- NCT00338104
- Acronym / sponsor ID
- 0361-028
- Conditions
- Hyperglycemia, Diabetes
- Keywords
- insulin, glargine, intravenous, subcutaneous, hospital, diabetes, glucose, inpatient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Sanofi
- Study start
- Jul 2004
- Primary completion
- May 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 20 Jun 2006 (estimated)
- Results
- Posted 6 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design.
Note: Lantus insulin is the proprietary name for glargine insulin.
Detailed description
Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart.
Subjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows:
- Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;
- Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion;
- Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion.
The glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 40% Glargine | Experimental | Drug: insulin glarginePatients will receive a dose of glargine insulin equal to 40% of insulin drip rate. |
| 60% Glargine | Experimental | Drug: insulin glarginePatients will receive a dose of glargine insulin equal to 60% of insulin drip rate. |
| 80% Glargine | Experimental | Drug: insulin glarginePatients will receive a dose of glargine insulin equal to 80% of insulin drip rate. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fasting glucose > 100 mg/dl
- Patients on surgical services or in intensive care units receiving intravenous insulin
Key exclusion criteria (4 listed)
- Inability to obtain informed consent from patient or next-of-kin
- Allergy to insulin
- Participation in another research study
- Patients for whom there are "do-not-resuscitate" orders
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 |
|---|---|---|
| insulin glargineAlso: Lantus is brand name for GlargineInsulin glargine given at 40% of prior stable drip rate. | Drug | 40% Glargine |
| insulin glargineAlso: Lantus is brand name for GlargineInsulin glargine given at 60% of prior stable drip rate. | Drug | 60% Glargine |
| insulin glargineAlso: Lantus is brand name for GlargineInsulin glargine given at 80% of prior stable drip rate. | Drug | 80% Glargine |
Primary outcome
Percentage of Blood Glucose Values Between 80 - 140
Time frame: First 24 hours after conversion
Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL
2 secondary outcomes
Percentage of Glucose Values < 50 mg/dL
Time frame: First 24 hours after conversion
Percentage of Glucose Levels > 180 mg/dL
Time frame: First 24 hours after conversion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17229660Schmeltz LR, DeSantis AJ, Schmidt K, O'Shea-Mahler E, Rhee C, Brandt S, Peterson S, Molitch ME. Conversion of intravenous insulin infusions to subcutaneously administered insulin glargine in patients with hyperglycemia. Endocr Pract. 2006 Nov-Dec;12(6):641-50. doi: 10.4158/EP.12.6.641.
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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.
Mark E Molitch, M.D. principal investigator
Northwestern 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 insulin glargine in people with Hyperglycemia and Diabetes, run by Northwestern 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 2 inclusion and 4 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 6 Apr 2009. 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 6 Apr 2009). 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?
Percentage of Blood Glucose Values Between 80 - 140 (time frame: First 24 hours after conversion). 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 NCT00338104, which also lists 1 linked publication.
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 6 Apr 2009.