Diabetic KetoacidosisDKANCT00920725
Subcutaneous Aspart Insulin to Treat Diabetic Ketoacidosis (DKA) and Beta-Hydroxybutyrate Testing in DKA
A study testing Insulin (Aspart Insulin [Novolog], Regular Insulin) in people with Diabetic Ketoacidosis, run by Rush University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Insulin (Aspart Insulin [Novolog], Regular Insulin)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Dec 2007
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- venous pH < 7.3 or arterial < 7.35
- at least 2 of the following 3:
- serum HCO3 < 18/anion gap > 16
- serum glucose > 300 mg/dl
- serum acetone positive
Who cannot join
- pregnant
- less than age 18
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis
The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- Insulin (Aspart Insulin [Novolog], Regular Insulin)
- Keywords
- DKA
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin (Aspart Insulin [Novolog], Regular Insulin)Drug
Aspart Insulin 0.2units/sq q 2 hours
Regular Insulin 0.1units/kg/hr intravenous
Aspart Insulin 0.1 units/kg/hr intravenous
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Insulin | Active comparator | Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours Receives: Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin) |
| IV Regular Insulin | Active comparator | Intravenous Regular Insulin 0.1 units/kg/hour Receives: Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin) |
| Intravenous Novolog Insulin | Active comparator | Intravenous Novolog Insulin 0.1 units/kg/hour Receives: Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
Measured: q 2 hours
Hours to achieve blood glucose less than 200mg/dl
Measured: q 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2009 (estimated)
- Study startJan 2005
- Primary completionJul 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, David Baldwin, Rush University Medical Center
- Investigators
- Rema A Gupta, MD, Principal investigator, Rush University Medical CenterDavid Baldwin, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00920725
- Sponsor's protocol ID
- 05012103
- Acronym
- DKA
- Status last verified
- Aug 2012
- First submitted
- 12 Jun 2009
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Aspart Insulin and Point of Care Beta Hydroxybutyrate Testing: A New Paradigm for the Management of Diabetic Ketoacidosis
- ClinicalTrials.gov ID
- NCT00920725
- Acronym / sponsor ID
- DKA / 05012103
- Conditions
- Diabetic Ketoacidosis
- Keywords
- DKA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- Jan 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 15 Jun 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.
The purpose of this study is to determine whether insulin administered by a subcutaneous injection is effective in the treatment of a diabetic crisis and to determine if beta-hydroxybutyrate is useful to monitor during treatment of a diabetic crisis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Insulin | Active comparator | Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)Aspart Insulin administered subcutaneously 0.2 units/kg/sq every 2 hours |
| IV Regular Insulin | Active comparator | Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)Intravenous Regular Insulin 0.1 units/kg/hour |
| Intravenous Novolog Insulin | Active comparator | Drug: Insulin (Aspart Insulin [Novolog], Regular Insulin)Intravenous Novolog Insulin 0.1 units/kg/hour |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- venous pH < 7.3 or arterial < 7.35
- at least 2 of the following 3:
Key exclusion criteria (2 listed)
- pregnant
- less than age 18
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 (Aspart Insulin [Novolog], Regular Insulin)Aspart Insulin 0.2units/sq q 2 hours Regular Insulin 0.1units/kg/hr intravenous Aspart Insulin 0.1 units/kg/hr intravenous | Drug | IV Regular Insulin, Intravenous Novolog Insulin, Subcutaneous Insulin |
Primary outcome
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6
Time frame: q 2 hours
Hours to achieve blood glucose less than 200mg/dl
Time frame: q 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
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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.
Rema A Gupta, MD principal investigator
Rush University Medical Center
David Baldwin, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin (Aspart Insulin [Novolog], Regular Insulin) in people with Diabetic Ketoacidosis, run by Rush University Medical Center 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 5 inclusion and 2 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 16 Aug 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hours to resolution of ketoacidosis as defined as beta-hydroxybutyrate <0.6 (time frame: q 2 hours). The study lists 2 primary outcomes in all. 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 16 Aug 2012.