HyperglycemiaPhase 3NCT00943709
Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
A Phase 3 study testing insulin glargine recombinant and therapeutic insulin in people with Hyperglycemia and Leukemia, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.
Trial summary
RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Leukemia
- What is being tested?
- insulin glargine recombinant and therapeutic insulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Mar 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
DISEASE CHARACTERISTICS:
- Histologically confirmed acute myeloid leukemia or acute lymphoid leukemia
- Newly diagnosed or relapsed disease
- Undergoing induction or salvage chemotherapy treatment
- Must demonstrate 2 random blood sugars of ≥ 140 mg/dL while on total parenteral nutrition (TPN) OR 2 preprandial sugars of ≥ 140 mg/dL if patient is not on TPN
PATIENT CHARACTERISTICS:
- ECOG performance status 0-3
- Not pregnant or nursing
- Negative pregnancy test
- Prior diagnosis of diabetes mellitus allowed
- No known history of an allergy to insulin
- No documented active infection
PRIOR CONCURRENT THERAPY:
- Concurrent corticosteroids allowed
- No concurrent oral hypoglycemic agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
About this study
Official title: Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.
PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Read the detailed description
OBJECTIVES:
Primary
- To determine whether intensive glycemic control over an eight week time period will decrease the incidence of infections from initiation of chemotherapy treatment in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Secondary
- To compare the number of episodes of infection.
- To compare the duration of neutropenia.
- To compare the number of days of bacteremia/fungemia.
- To compare the number of days of fever.
- To compare the duration of nutrition.
- To compare the duration of mucositis.
- To compare the duration of hospital stay.
- To compare the duration of antibiotic use.
- To compare the incidence of thromboembolic events.
- To compare body weight changes.
- To compare the median survival.
- To compare the remission rate with induction or salvage chemotherapy.
- To conduct comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I (intensive glycemic control): Patients with goal blood glucose 80-140 mg/dL receive the Robert Wood Johnson University Hospital IV insulin infusion protocol to maintain blood glucoses in the target range. Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks as needed. Patients may also receive insulin in the total parenteral nutrition (TPN) mixture.
- Arm II (standard care control): Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. Insulin may also be added to TPN if needed at the investigator's discretion.
After completion of study treatment, patients are followed up for 4 weeks.
- Conditions
- Hyperglycemia, Leukemia
- Being tested
- insulin glargine recombinant, therapeutic insulin
- Keywords
- hyperglycemia, recurrent adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia
- Medical subject headings
- Hyperglycemia, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Congenital Abnormalities, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insulin glargine recombinantBiological
Given subcutaneously
therapeutic insulinDrug
Given subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients with goal blood glucose 80-14 mg/dL receive the Robert Wood Johnson Hospital IV insulin infusion protocol followed by insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks. Receives: Biological: insulin glargine recombinant; Drug: therapeutic insulin |
| Arm II | Active comparator | Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. Receives: Biological: insulin glargine recombinant; Drug: therapeutic insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new infections
Measured: 4 years
Secondary outcomes (13)
Number of episodes of infection
Measured: 4 years
Duration of neutropenia
Measured: 4 years
Number of days of bacteremia/fungemia
Measured: 4 years
Number of days of fever
Measured: 4 years
Duration of nutrition
Measured: 4 years
Duration of mucositis
Measured: 4 years
Duration of hospital stay
Measured: 4 years
Duration of antibiotic use
Measured: 4 years
Incidence of thromboembolic events
Measured: 4 years
Body weight changes
Measured: 4 years
Median survival
Measured: 4 years
Remission rate with induction or salvage chemotherapy
Measured: 4 years
Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: lack of accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Dentistry of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sanofi
- Responsible party
- Sponsor
- Investigators
- Mecide Gharibo, MD, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00943709
- Sponsor's protocol ID
- 060601
- Other IDs
- AVENTIS-CINJ-060601, 0220070268, CDR0000648982, P30CA072720
- Status last verified
- Aug 2013
- First submitted
- 21 Jul 2009
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intensive Glycemic Control on Infectious Morbidity In Patients With Acute Leukemia
- ClinicalTrials.gov ID
- NCT00943709
- Acronym / sponsor ID
- 060601
- Conditions
- Hyperglycemia, Leukemia
- Keywords
- hyperglycemia, recurrent adult acute lymphoblastic leukemia, untreated adult acute lymphoblastic leukemia, adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Medicine and Dentistry of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Sanofi
- Study start
- May 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 22 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Controlling blood sugar levels may be effective in preventing infections in patients receiving chemotherapy for acute myeloid leukemia or acute lymphoblastic leukemia.
PURPOSE: This randomized phase I trial is studying how well controlling blood sugar levels works in preventing infection in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Detailed description
OBJECTIVES:
Primary
- To determine whether intensive glycemic control over an eight week time period will decrease the incidence of infections from initiation of chemotherapy treatment in patients with acute myeloid leukemia or acute lymphoblastic leukemia.
Secondary
- To compare the number of episodes of infection.
- To compare the duration of neutropenia.
- To compare the number of days of bacteremia/fungemia.
- To compare the number of days of fever.
- To compare the duration of nutrition.
- To compare the duration of mucositis.
- To compare the duration of hospital stay.
- To compare the duration of antibiotic use.
- To compare the incidence of thromboembolic events.
- To compare body weight changes.
- To compare the median survival.
- To compare the remission rate with induction or salvage chemotherapy.
- To conduct comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I (intensive glycemic control): Patients with goal blood glucose 80-140 mg/dL receive the Robert Wood Johnson University Hospital IV insulin infusion protocol to maintain blood glucoses in the target range. Beginning 24 hours after maintenance of oral or enteral feedings patients receive an intensive regimen of insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks as needed. Patients may also receive insulin in the total parenteral nutrition (TPN) mixture.
- Arm II (standard care control): Patients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. Insulin may also be added to TPN if needed at the investigator's discretion.
After completion of study treatment, patients are followed up for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Biological: insulin glargine recombinant, Drug: therapeutic insulinPatients with goal blood glucose 80-14 mg/dL receive the Robert Wood Johnson Hospital IV insulin infusion protocol followed by insulin glargine and insulin glulisine (Apidra™) subcutaneously for 4 weeks. |
| Arm II | Active comparator | Biological: insulin glargine recombinant, Drug: therapeutic insulinPatients with goal blood glucose < 250 mg/dL are started on subcutaneous insulin sliding scale at the discretion of the treating physician with blood glucose monitoring and adjustment according to the insulin sliding scale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 glargine recombinantGiven subcutaneously | Biological | Arm I, Arm II |
| therapeutic insulinGiven subcutaneously | Drug | Arm I, Arm II |
Primary outcome
Incidence of new infections
Time frame: 4 years
13 secondary outcomes
Number of episodes of infection
Time frame: 4 years
Duration of neutropenia
Time frame: 4 years
Number of days of bacteremia/fungemia
Time frame: 4 years
Number of days of fever
Time frame: 4 years
Duration of nutrition
Time frame: 4 years
Duration of mucositis
Time frame: 4 years
Duration of hospital stay
Time frame: 4 years
Duration of antibiotic use
Time frame: 4 years
Incidence of thromboembolic events
Time frame: 4 years
Body weight changes
Time frame: 4 years
Median survival
Time frame: 4 years
Remission rate with induction or salvage chemotherapy
Time frame: 4 years
Comparative analysis between intervention and standard of care groups of mean daily capillary blood glucose monitoring
Time frame: 4 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2013.
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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.
Mecide Gharibo, MD principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing insulin glargine recombinant and therapeutic insulin in people with Hyperglycemia and Leukemia, run by University of Medicine and Dentistry of New Jersey 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?
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: withdrawn, as of the sponsor's last update on 30 Aug 2013. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Incidence of new infections (time frame: 4 years). 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 30 Aug 2013.