Critically IllPhase 2NCT00798590
The Efficacy of Glucagon Like Peptide (GLP) - 1(7-36) Amide for Glycemic Control in Critically Ill Patients
A Phase 2 study testing Glucagon-Like Peptide-1 and Saline in people with Critically Ill and Hypoglycemia, run by Johns Hopkins University at 1 site in United States.
Trial summary
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Critically Ill, Hypoglycemia
- What is being tested?
- Glucagon-Like Peptide-1 and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jun 2011
- Phase
- Phase 2
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age > 21 to 75 years of age.
- All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
- Able to obtain patient or proxy consent.
Who cannot join
- Current diagnosis of malignancy.
- Type 1 diabetes.
- Inability to obtain informed consent.
- On any Phase 1 trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
Read the detailed description
All patients whom on admission to the ICU (surgical, burn, \& cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.
- Conditions
- Critically Ill, Hypoglycemia
- Being tested
- Glucagon-Like Peptide-1, Saline
- Keywords
- Intensive insulin therapy (IIT), Insulin infusion, Tight glycemic control, Intensive Care Units
- Medical subject headings
- Critical Illness, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon-Like Peptide-1Drug
Also called GLP-1
5ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours.
SalineDrug
5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Experimental | Not described Receives: Drug: Glucagon-Like Peptide-1 |
| Saline | Placebo comparator | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
Measured: 2 years
Secondary outcomes (1)
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2010
- Study completionJun 2011
Why it stopped: PI left JHU
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 Critically IllStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Responsible party
- Sponsor
- Investigators
- Dariush Elahi, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798590
- Sponsor's protocol ID
- NA_00022551
- Status last verified
- Jun 2017
- First submitted
- 25 Nov 2008
- Last updated
- 2 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of GLP - 1 (7-36) Amide for Glycemic Control in Critically Ill Surgical Patients
- ClinicalTrials.gov ID
- NCT00798590
- Acronym / sponsor ID
- NA_00022551
- Conditions
- Critically Ill, Hypoglycemia
- Keywords
- Intensive insulin therapy (IIT), Insulin infusion, Tight glycemic control, Intensive Care Units
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left JHU
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Society of Critical Care Medicine
- Study start
- Dec 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 26 Nov 2008 (estimated)
- Results
- Posted 2 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this present proposal is to examine the efficacy of GLP-1 administered to control blood glucose in critically ill patients.
Detailed description
All patients whom on admission to the ICU (surgical, burn, \& cardiac) who are expected to receive intensive insulin therapy for at least 72 hours are eligible to be enrolled. Once enrolled, the patients will be randomized to one of two groups: the experimental (intravenous GLP-1 infusion for 72 hours) or control groups (intravenous 0.9% sodium chloride (NaCl) infusion for 72 hours) in a double masked fashion. While enrolled, all patients will receive standard-of-care insulin therapy. Both groups will be maintained on the standard ICU specific protocol for glucose control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Experimental | Drug: Glucagon-Like Peptide-1 |
| Saline | Placebo comparator | Drug: Saline |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women age > 21 to 75 years of age.
- All subjects who meet ICU specific criteria for inclusion in their glucose protocol and placed on insulin infusion protocol as standard of care.
- Able to obtain patient or proxy consent.
Key exclusion criteria (4 listed)
- Current diagnosis of malignancy.
- Type 1 diabetes.
- Inability to obtain informed consent.
- On any Phase 1 trial.
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 |
|---|---|---|
| Glucagon-Like Peptide-1Also: GLP-15ng/kg-1/min-1 GLP-1 infused in 3 ml continuously over 72 hours. | Drug | GLP-1 |
| Saline5ng/kg-1/min-1 placebo infused in 3 ml continuously over 72 hours. | Drug | Saline |
Primary outcome
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range.
Time frame: 2 years
1 secondary outcome
Compare the Number of Hypoglycemic Events Between GLP-1/Placebo Treatment
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- 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.
Dariush Elahi, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucagon-Like Peptide-1 and Saline in people with Critically Ill and Hypoglycemia, run by Johns Hopkins 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 3 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: stopped early, as of the sponsor's last update on 2 Jul 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 2 Jul 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?
To Compare the Composite Overall Amount of Insulin Used With GLP-1 vs. Placebo to Reach and Maintain the ICU-specific Target Glucose Range. (time frame: 2 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 2 Jul 2017.