HyperglycemiaPhase 4GIHNCT01810952
The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
A Phase 4 study testing Glargine insulin, Lispro insulin and NPH Insulin in people with Hyperglycemia and Diabetes Mellitus, run by Baylor College of Medicine at 1 site in United States.
Trial summary
The investigators hypothesize that includes patient weight and glucocorticoid dose can be used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be treated with pharmacological doses of glucocorticoids. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hyperglycemia, Diabetes Mellitus
- What is being tested?
- Glargine insulin, Lispro insulin and NPH Insulin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2013
- 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
- Admission for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
- Treatment with pharmacological doses of glucocorticoids (GCs) ≥10 mg of prednisone or its equivalent if they are not on maintenance dose of GCs in the outpatient settings.
- Treatment with pharmacological doses of GCs ≥10 mg of prednisone or its equivalent above their maintenance dose of GCs in the outpatient settings.
- Have either a previous diagnosis of diabetes mellitus which has been treated with diet or medications, hemoglobin A1c ≥6.5%, or confirmed inpatient hyperglycemia defined as a fasting laboratory glucose or finger stick reading ≥126 mg/dL or random glucose reading ≥200 mg/dL on two or more determinations.
Who cannot join
- Unwilling to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that includes patient weight and glucocorticoid dose can be used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be treated with pharmacological doses of glucocorticoids.
Read the detailed description
The target fasting serum glucose (FSG) and pre-meal SG was 90-140 mg/dL, and the random SG was less than 180 mg/dL, taking into consideration the ADA/AACE target glucose levels in non-ICU patients (15).
The Glargine/Lispro Protocol included 0.2 unit/kg/day as insulin glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
The Glargine/Lispro/NPH Protocol included 0.2 unit/kg/day as insulin glargine as per G/L; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of Neutral Protamine Hagedorn (NPH) for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.
The NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. The NPH dose was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
In both protocols glargine dose was increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.
If the patient had an outpatient regimen which includes a total daily dose of insulin (TDI) that exceeded 0.4 unit/kg/day, then the same TDI was continued with 50% given as glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; and 50% given as lispro divided between three meals. The patient was still randomly assigned to either one of the two protocols as described previously.
If the patient were on a TDI less than 0.4 unit/kg/day in addition to oral antidiabetic medications as an outpatient, then all the oral antidiabetic medications were discontinued and the patient was started on 0.5 unit/kg/day divided as 50% glargine given once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; and 50% lispro divided between three meals. The patient was randomly assigned to either one of the two protocols based upon even and odd hospital numbers.
- Conditions
- Hyperglycemia, Diabetes Mellitus
- Being tested
- Glargine insulin, Lispro insulin, NPH Insulin
- Keywords
- glucocorticoids, hyperglycemia, diabetes mellitus
- Medical subject headings
- Hyperglycemia, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glargine insulinDrug
In both protocols glargine dose was increased by 10% if the FSG value was 141-200 mg/dL and by 20% if the FSG value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.
Lispro insulinDrug
In both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm.
NPH InsulinDrug
NPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm
| Study group | Role | What they receive |
|---|---|---|
| Glargine/Lispro Insulin Arm | Experimental | Drug: Glargine insulin was administered per above.
Drug: Lispro insulin 0.2 unit/kg/day was administered per above. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
Drug: prednisone or equivalent dose was determined by severity of exacerbation and clinician's judgement. Receives: Drug: Glargine insulin; Drug: Lispro insulin |
| Glargine/Lispro/NPH Insulin Arm | Experimental | Drugs Glargine and Lispro insulin included similar starting doses of glargine and lispro.
Drug: A "coverage" dose of NPH insulin 0.1 unit/kg/day for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. Maximum starting "coverage" dose was 0.4 units/kg per day. NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. It was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
Drug: the dose of prednisone or equivalent glucocorticoid was determined by severity of exacerbation and clinician's judgement. Receives: Drug: Glargine insulin; Drug: Lispro insulin; Drug: NPH Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."
Measured: 1-5 days
Secondary outcomes (3)
Percent of Participants With Average Glucose >70 and <180 mg/dL
Percent of Participants with Average Daily Glucose >70 and <180 mg/dL
Measured: Last Full Day of Protocol for Participant (up to Day 5)
Daily Insulin Dose/Kg Body Weight
Total daily dose of insulin required based on weight and glucocorticoid dosage to achieve average daily finger stick glucose (FSG) levels of 90-140 mg/dL
Measured: 1-5 days
Glucose Values <70 mg/dL.
# participants with glucose values <70 mg/dL
Measured: 1-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2013 (estimated)
- Study startSep 2010
- Primary completionSep 2013
- Study completionSep 2013
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 (2)Papers the sponsor has linked to this study.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenn R. Cunningham, Baylor College of Medicine
- Investigators
- Glenn R Cunningham, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810952
- Sponsor's protocol ID
- H-27172
- Acronym
- GIH
- Status last verified
- Feb 2017
- First submitted
- 11 Mar 2013
- Last updated
- 8 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.
PubMed 19454391Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available.
PubMed 19429873
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
- ClinicalTrials.gov ID
- NCT01810952
- Acronym / sponsor ID
- GIH / H-27172
- Conditions
- Hyperglycemia, Diabetes Mellitus
- Keywords
- glucocorticoids, hyperglycemia, diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Mar 2013 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that includes patient weight and glucocorticoid dose can be used to safely initiate insulin treatment in diabetic/hyperglycemic patients who are to be treated with pharmacological doses of glucocorticoids.
Detailed description
The target fasting serum glucose (FSG) and pre-meal SG was 90-140 mg/dL, and the random SG was less than 180 mg/dL, taking into consideration the ADA/AACE target glucose levels in non-ICU patients (15).
The Glargine/Lispro Protocol included 0.2 unit/kg/day as insulin glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day.
The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
The Glargine/Lispro/NPH Protocol included 0.2 unit/kg/day as insulin glargine as per G/L; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A "coverage" dose of 0.1 unit/kg/day of Neutral Protamine Hagedorn (NPH) for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting "coverage" dose was 0.4 units/kg per day.
The NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. The NPH dose was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL.
In both protocols glargine dose was increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.
If the patient had an outpatient regimen which includes a total daily dose of insulin (TDI) that exceeded 0.4 unit/kg/day, then the same TDI was continued with 50% given as glargine once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; and 50% given as lispro divided between three meals. The patient was still randomly assigned to either one of the two protocols as described previously.
If the patient were on a TDI less than 0.4 unit/kg/day in addition to oral antidiabetic medications as an outpatient, then all the oral antidiabetic medications were discontinued and the patient was started on 0.5 unit/kg/day divided as 50% glargine given once daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; and 50% lispro divided between three meals. The patient was randomly assigned to either one of the two protocols based upon even and odd hospital numbers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glargine/Lispro Insulin Arm | Experimental | Drug: Glargine insulin, Drug: Lispro insulinDrug: Glargine insulin was administered per above. Drug: Lispro insulin 0.2 unit/kg/day was administered per above. A "coverage" dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting "coverage" dose was 0.4 units/kg per day. The prandial dose of lispro was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG is >200 mg/dL. The prandial dose of lispro was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL. Drug: prednisone or equivalent dose was determined by severity of exacerbation and clinician's judgement. |
| Glargine/Lispro/NPH Insulin Arm | Experimental | Drug: Glargine insulin, Drug: Lispro insulin, Drug: NPH InsulinDrugs Glargine and Lispro insulin included similar starting doses of glargine and lispro. Drug: A "coverage" dose of NPH insulin 0.1 unit/kg/day for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. Maximum starting "coverage" dose was 0.4 units/kg per day. NPH dose was increased by 10% if the pre-lunch, pre-dinner, or bedtime SG is between 141-200 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was greater than 200 mg/dL. It was decreased by 10% if the pre-lunch, pre-dinner, or bedtime SG was between 70-89 mg/dL, and by 20% if the pre-lunch, pre-dinner or bedtime SG was less than 70 mg/dL. Drug: the dose of prednisone or equivalent glucocorticoid was determined by severity of exacerbation and clinician's judgement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Admission for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
- Treatment with pharmacological doses of glucocorticoids (GCs) ≥10 mg of prednisone or its equivalent if they are not on maintenance dose of GCs in the outpatient settings.
- Treatment with pharmacological doses of GCs ≥10 mg of prednisone or its equivalent above their maintenance dose of GCs in the outpatient settings.
- Have either a previous diagnosis of diabetes mellitus which has been treated with diet or medications, hemoglobin A1c ≥6.5%, or confirmed inpatient hyperglycemia defined as a fasting laboratory glucose or finger stick reading ≥126 mg/dL or random glucose reading ≥200 mg/dL on two or more determinations.
Key exclusion criteria (1 listed)
- Unwilling to sign informed consent.
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 |
|---|---|---|
| Glargine insulinIn both protocols glargine dose was increased by 10% if the FSG value was 141-200 mg/dL and by 20% if the FSG value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL. | Drug | Glargine/Lispro Insulin Arm, Glargine/Lispro/NPH Insulin Arm |
| Lispro insulinIn both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm. | Drug | Glargine/Lispro Insulin Arm, Glargine/Lispro/NPH Insulin Arm |
| NPH InsulinNPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm | Drug | Glargine/Lispro/NPH Insulin Arm |
Primary outcome
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol.
Time frame: 1-5 days
Most patients had 4 and all patients had at least 2 readings each day. Average daily glucose values were determined for each participant, then averaged for each Arm."
3 secondary outcomes
Percent of Participants With Average Glucose >70 and <180 mg/dL
Time frame: Last Full Day of Protocol for Participant (up to Day 5)
Daily Insulin Dose/Kg Body Weight
Time frame: 1-5 days
Glucose Values <70 mg/dL.
Time frame: 1-5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19454391Clore JN, Thurby-Hay L. Glucocorticoid-induced hyperglycemia. Endocr Pract. 2009 Jul-Aug;15(5):469-74. doi: 10.4158/EP08331.RAR.
- Background: PubMed 19429873Moghissi ES, Korytkowski MT, DiNardo M, Einhorn D, Hellman R, Hirsch IB, Inzucchi SE, Ismail-Beigi F, Kirkman MS, Umpierrez GE; American Association of Clinical Endocrinologists; American Diabetes Association. American Association of Clinical Endocrinologists and American Diabetes Association consensus statement on inpatient glycemic control. Diabetes Care. 2009 Jun;32(6):1119-31. doi: 10.2337/dc09-9029. Epub 2009 May 8. No abstract available.
- Individual participant dataSharing planned: No
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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.
Glenn R Cunningham, MD principal investigator
Baylor College of Medicine
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 Glargine insulin, Lispro insulin and NPH Insulin in people with Hyperglycemia and Diabetes Mellitus, run by Baylor College of Medicine 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 1 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 8 Feb 2017. 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 9 Jan 2017). 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?
Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol. (time frame: 1-5 days). 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 NCT01810952, which also lists 2 linked publications.
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 8 Feb 2017.