ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02006342
Recruitment Status : Completed
First Posted : December 10, 2013
Results First Posted : May 16, 2017
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
Pratik B Doshi, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Diabetic Ketoacidosis
Interventions Drug: Insulin Glargine
Drug: Regular Insulin
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Period Title: Overall Study
Started 20 20
Completed 19 20
Not Completed 1 0
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin Total
Hide Arm/Group Description

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
All who were enrolled
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 20 participants 20 participants 40 participants
38.5
(31.5 to 45.5)
41.5
(29.0 to 50.5)
41
(29 to 49.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
6
  30.0%
10
  50.0%
16
  40.0%
Male
14
  70.0%
10
  50.0%
24
  60.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Time to Anion Gap Closure
Hide Description 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.
Time Frame Participants monitored from hospital admission to discharge, an average of 4 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description:

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: hours
10.2  (6.8) 11.6  (6.4)
2.Secondary Outcome
Title Number of Participants Admitted to the ICU
Hide Description 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.
Time Frame Participants followed for the duration of the Emergency Department stay, an expected average of 12 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description:

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
6 4
3.Secondary Outcome
Title Intensive Care Unit Length of Stay
Hide Description 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.
Time Frame Participants monitored from hospital admission to discharge, an average of 4 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description:

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Overall Number of Participants Analyzed 20 20
Median (Inter-Quartile Range)
Unit of Measure: days
1.8
(1.6 to 1.9)
1.2
(0.8 to 1.8)
4.Secondary Outcome
Title Hospital Length of Stay
Hide Description 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.
Time Frame Participants monitored from hospital admission to discharge, an average of 4 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description:

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Overall Number of Participants Analyzed 20 20
Mean (Standard Error)
Unit of Measure: days
3.9  (3.4) 4.6  (3.6)
5.Secondary Outcome
Title Number of Participants Who Developed Hypoglycemia
Hide Description

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.

Time Frame Participants monitored during the 24 hours after anion gap closure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
While one participant in the glargine group did not receive glargine, all who were enrolled were analyzed (intention to treat analysis).
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description:

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

Overall Number of Participants Analyzed 20 20
Measure Type: Number
Unit of Measure: participants
2 3
Time Frame 24 hours after anion gap closure
Adverse Event Reporting Description Participants were systematically assessed for hypoglycemia. 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.
 
Arm/Group Title Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Hide Arm/Group Description

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.

Insulin Glargine

Regular Insulin

Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.

Regular Insulin

All-Cause Mortality
Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/20 (0.00%)      0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Insulin Glargine Plus Regular Insulin Control - Regular Insulin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      3/20 (15.00%)    
Metabolism and nutrition disorders     
hypoglycemia   2/20 (10.00%)  2 3/20 (15.00%)  3
Indicates events were collected by systematic assessment
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.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Pratik B. Doshi
Organization: The University of Texas Health Science Center at Houston
Phone: 713-608-6537
Responsible Party: Pratik B Doshi, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02006342     History of Changes
Other Study ID Numbers: HSC-MS-12-0535
First Submitted: November 20, 2013
First Posted: December 10, 2013
Results First Submitted: April 10, 2017
Results First Posted: May 16, 2017
Last Update Posted: May 16, 2017