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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)

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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Insulin Glargine Plus Regular Insulin

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

Control - Regular Insulin

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

Regular Insulin


Participant Flow:   Overall Study
    Insulin Glargine Plus Regular Insulin   Control - Regular Insulin
STARTED   20   20 
COMPLETED   19   20 
NOT COMPLETED   1   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All who were enrolled

Reporting Groups
  Description
Insulin Glargine Plus Regular Insulin

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

Control - Regular Insulin

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

Regular Insulin

Total Total of all reporting groups

Baseline Measures
   Insulin Glargine Plus Regular Insulin   Control - Regular Insulin   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 38.5 
 (31.5 to 45.5) 
 41.5 
 (29.0 to 50.5) 
 41 
 (29 to 49.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      6  30.0%      10  50.0%      16  40.0% 
Male      14  70.0%      10  50.0%      24  60.0% 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures

1.  Primary:   Time to Anion Gap Closure   [ Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days ]

2.  Secondary:   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 ]

3.  Secondary:   Intensive Care Unit Length of Stay   [ Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days ]

4.  Secondary:   Hospital Length of Stay   [ Time Frame: Participants monitored from hospital admission to discharge, an average of 4 days ]

5.  Secondary:   Number of Participants Who Developed Hypoglycemia   [ Time Frame: Participants monitored during the 24 hours after anion gap closure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: Pratik.B.Doshi@uth.tmc.edu


Publications of Results:
Other Publications:

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