Diabetic KetoacidosisGT-COGNCT02006342

Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis

A study testing Insulin Glargine and Regular Insulin in people with Diabetic Ketoacidosis, run by The University of Texas Health Science Center, Houston at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine if co-administration of subcutaneous (SQ)Insulin glargine in combination with intravenous (IV) insulin decreases the time to resolution of ketoacidosis and requirement for ICU admission compared to IV insulin with delayed administration of SQ glargine for the treatment of diabetic ketoacidosis (DKA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Ketoacidosis
What is being tested?: Insulin Glargine and Regular Insulin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: Nov 2012to Apr 2013
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age >18 years
Blood Glucose >200
potential of hydrogen (pH) < 7.3
Bicarbonate < 18
Ketonemia or Ketonuria
Anion Gap > or = 16

Who cannot join

Age < 18 years
Pregnant
End state renal disease (ESRD)
Prisoners
Patients in shock or requiring emergency surgery
Those unwilling to consent for the trial
Allergic to Insulin Glargine

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Lyndon B Johnson Hospital
Houston, Texas, 77026
Memorial Herman Hospital-Texas Medical Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study

Conditions: Diabetic Ketoacidosis
Being tested: Insulin Glargine, Regular Insulin
Keywords: Diabetes Mellitus, Diabetic Ketoacidosis, Insulin Glargine, Anion gap, Metabolic acidosis
Medical subject headings: Diabetic Ketoacidosis, Diabetes Mellitus, Acidosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Insulin GlargineDrug
Also called Lantus Insulin
Regular InsulinDrug

Study groups in NCT02006342
Study group	Role	What they receive
Insulin Glargine plus Regular Insulin	Experimental	Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis. Receives: Drug: Insulin Glargine; Drug: Regular Insulin
Control - Regular Insulin	Active comparator	Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring. Receives: Drug: Regular Insulin

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to Anion Gap Closure
Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.
Measured: Participants monitored from hospital admission to discharge, an average of 4 days

Secondary outcomes (4)

Number of Participants Admitted to the ICU
The goal was to determine if the amount of patients admitted to the ICU could be reduced by providing more efficient resolution of the critical condition which is the acidosis.
Measured: Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours
Intensive Care Unit Length of Stay
Determine the amount of time patient is admitted to the intensive care unit with the goal of assessing if more efficient correction of the acidosis results in decreased time in the intensive care unit for the patients.
Measured: Participants monitored from hospital admission to discharge, an average of 4 days
Hospital Length of Stay
Hospital length of stay was determined to assess whether a more efficient correction of the acidosis will result in decreased time that the patient is admitted to the hospital. Results reported are adjusted for age, hospital site, and etiology of diabetic ketoacidosis.
Measured: Participants monitored from hospital admission to discharge, an average of 4 days
Number of Participants Who Developed Hypoglycemia
To determine whether it is safe to administer both IV and subcutaneous insulin, it is important to assure that patient's glucose does not drop to critically low level and lead to adverse events. Hypoglycemia was defined as less than or equal to 60mg/dL during 24 hours after anion gap closure.
Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production.
Measured: Participants monitored during the 24 hours after anion gap closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2012Apr 2013

First posted10 Dec 2013 (estimated)
Study startNov 2012
Primary completionApr 2013
Study completionApr 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 Diabetic KetoacidosisStudies of the same condition, open and under way.
More trials run by The University of Texas Health Science Center, HoustonThe 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: Single group
Masking: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02006342
Sponsor's protocol ID: HSC-MS-12-0535
Acronym: GT-COG
Status last verified: Apr 2017
First submitted: 20 Nov 2013
Last updated: 16 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17.
PubMed 17508198
Doshi P, Potter AJ, De Los Santos D, Banuelos R, Darger BF, Chathampally Y. Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study. Acad Emerg Med. 2015 Jun;22(6):657-62. doi: 10.1111/acem.12673. Epub 2015 May 25.
PubMed 26013711

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
RecruitingObservational study
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
Diabetes Mellitus, Type 1
RecruitingObservational study
Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
Diabetic Ketoacidosis
Not yet recruitingObservational study
Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
Diabetic Ketoacidosis, Diabetes Mellitus

All Diabetic Ketoacidosis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Subcutaneous Glargine On The Time To Closure of The Anion Gap in Patients Presenting to the Emergency Department With Diabetic Keto-acidosis: A Pilot Study
ClinicalTrials.gov ID: NCT02006342
Acronym / sponsor ID: GT-COG / HSC-MS-12-0535
Conditions: Diabetic Ketoacidosis
Keywords: Diabetes Mellitus, Diabetic Ketoacidosis, Insulin Glargine, Anion gap, Metabolic acidosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: The University of Texas Health Science Center, HoustonUniversity, hospital or other
Study start: Nov 2012
Primary completion: Apr 2013 (actual)
Study completion: Apr 2013 (actual)
First posted: 10 Dec 2013 (estimated)
Results: Posted 16 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Insulin Glargine plus Regular Insulin	Experimental	Drug: Insulin Glargine, Drug: Regular InsulinPatient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.
Control - Regular Insulin	Active comparator	Drug: Regular InsulinPatient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age >18 years
Blood Glucose >200
potential of hydrogen (pH) < 7.3
Bicarbonate < 18
Ketonemia or Ketonuria

Key exclusion criteria (7 listed)

Age < 18 years
Pregnant
End state renal disease (ESRD)
Prisoners
Patients in shock or requiring emergency surgery

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 Insulin	Drug	Insulin Glargine plus Regular Insulin
Regular Insulin	Drug	Control - Regular Insulin, Insulin Glargine plus Regular Insulin

Primary outcome

Time to Anion Gap Closure
Time frame: Participants monitored from hospital admission to discharge, an average of 4 days
Anion Gap is a measure of acidosis that results from decompensated Diabetes Mellitus. Acidosis is the result of the body being unable to utilize glucose for energy production and instead uses fatty acid metabolism resulting in ketone formation. Anion Gap is a surrogate measure for the level of ketones resulting in the excess acid production. Results reported are adjusted for initial anion gap, etiology of diabetic ketoacidosis, and comorbidities.

4 secondary outcomes

Number of Participants Admitted to the ICU
Time frame: Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours
Intensive Care Unit Length of Stay
Time frame: Participants monitored from hospital admission to discharge, an average of 4 days
Hospital Length of Stay
Time frame: Participants monitored from hospital admission to discharge, an average of 4 days
Number of Participants Who Developed Hypoglycemia
Time frame: Participants monitored during the 24 hours after anion gap closure

Results and safety

Results posted to the registry on 16 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Glargine Plus Regular Insulin	20	19
Control - Regular Insulin	20	20

Primary outcome: Time to Anion Gap Closure

Time frame: Participants monitored from hospital admission to discharge, an average of 4 days. Mean (Standard Error). Unit: hours

Measure	Insulin Glargine Plus Regular Insulin n = 20	Control - Regular Insulin n = 20
Value	10.2 (6.8)	11.6 (6.4)

Population analysed: While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24 hours after anion gap closure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Glargine Plus Regular Insulin	0 of 20 (0%)	2 of 20 (10%)	Not reported
Control - Regular Insulin	0 of 20 (0%)	3 of 20 (15%)	Not reported

Limitations and caveats (from the sponsor): The study had a limited sample size; therefore, the results cannot definitively answer the research question. Also, because a convenience sample was used, there might be selection bias.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17508198Shankar V, Haque A, Churchwell KB, Russell W. Insulin glargine supplementation during early management phase of diabetic ketoacidosis in children. Intensive Care Med. 2007 Jul;33(7):1173-1178. doi: 10.1007/s00134-007-0674-3. Epub 2007 May 17.
Results publication: PubMed 26013711Doshi P, Potter AJ, De Los Santos D, Banuelos R, Darger BF, Chathampally Y. Prospective randomized trial of insulin glargine in acute management of diabetic ketoacidosis in the emergency department: a pilot study. Acad Emerg Med. 2015 Jun;22(6):657-62. doi: 10.1111/acem.12673. Epub 2015 May 25.

Related trials for Diabetic Ketoacidosis

Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
RecruitingObservational study
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
Diabetes Mellitus, Type 1
RecruitingObservational study
Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
Diabetic Ketoacidosis
Not yet recruitingObservational study
Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
Diabetic Ketoacidosis, Diabetes Mellitus

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.

Pratik B Doshi, MD principal investigator

The University of Texas Health Science Center, Houston

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Insulin Glargine and Regular Insulin in people with Diabetic Ketoacidosis, run by The University of Texas Health Science Center, Houston at 2 sites 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 6 inclusion and 7 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 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 16 May 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?

Time to Anion Gap Closure (time frame: Participants monitored from hospital admission to discharge, an average of 4 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 NCT02006342, 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 16 May 2017.