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Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)

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ClinicalTrials.gov Identifier: NCT00590044
Recruitment Status : Completed
First Posted : January 10, 2008
Results First Posted : April 30, 2009
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Guillermo Umpierrez, MD, Emory University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Ketoacidosis
Interventions Drug: insulin glargine+ glulisine
Drug: NPH + Regular insulin
Enrollment 74

Recruitment Details This study was conducted at Grady Memorial Hospital, Atlanta, Georgia, and at Hennepin County Medical Center, Minneapolis, Minnesota
Pre-assignment Details A total of 74 patients with DKA were randomly assigned. Of them, 6 were excluded because 4 withdrew consent before or shortly after initiation of insulin therapy, one patient received glargine insulin before resolution of DKA, and one patient was treated with IV aspart insulin instead of regular insulin. The remaining 68 were included in analysis
Arm/Group Title Glargine (Lantus) + Glulisine NPH + Regular
Hide Arm/Group Description Daily insulin glargine (Lantus) + glulisine (Apidra) before meals Split-mixed NPH + Regular insulin twice daily
Period Title: Overall Study
Started 38 36
Completed 34 34
Not Completed 4 2
Reason Not Completed
Withdrawal by Subject             2             2
wrong insulin arm assigned             1             0
Protocol Violation             1             0
Arm/Group Title Glargine (Lantus) + Glulisine NPH + Regular Total
Hide Arm/Group Description Daily insulin glargine (Lantus) + glulisine (Apidra) before meals Split-mixed NPH + Regular insulin twice daily Total of all reporting groups
Overall Number of Baseline Participants 38 36 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 36 participants 74 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
38
 100.0%
36
 100.0%
74
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 36 participants 74 participants
39  (12) 38  (12) 38.5  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 36 participants 74 participants
Female
14
  36.8%
12
  33.3%
26
  35.1%
Male
24
  63.2%
24
  66.7%
48
  64.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 38 participants 36 participants 74 participants
38 36 74
1.Primary Outcome
Title Number of Hypoglycemia Episodes After the Transition Period From Intravenous Insulin to Subcutaneous Insulin Between 2 Treatment Groups
Hide Description To determine the safety of the two treatments the number of hypoglycemia episodes that occurred between the 2 groups are measured from the time of transitioning to subcutaneous insulin to day 5. The hypoglycemia events are defined as blood glucose levels <70 mg/dL. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.
Time Frame 5 days after transitioning to subcutaneous insulin
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Insulin Glargine+Glulisine Split-mixed NPH + Regular Insulin
Hide Arm/Group Description:

Daily insulin glargine + glulisine before meals

insulin glargine+ glulisine: Daily insulin glargine + glulisine before meals

Split-mixed NPH + Regular insulin twice daily

NPH + Regular insulin: Split-mixed NPH + Regular insulin twice daily

Overall Number of Participants Analyzed 34 34
Measure Type: Number
Unit of Measure: number of hypoglycemia episodes
8 26
2.Secondary Outcome
Title Mean Daily Blood Glucose Concentration Between the Two Groups After the Resolution of Ketoacidosis and Transition to Subcutaneous Insulin
Hide Description The primary outcome during the subcutaneous (SC) period (the primary outcome measurement) was to determine differences in glycemic control as measured by mean daily blood glucose(BG) concentration between treatment groups. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed Identification (ID): 19366972.
Time Frame Day1 - Day5 after the resolution of ketoacidosis and transition to subcutaneous insulin
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine (Lantus) + Glulisine NPH + Regular
Hide Arm/Group Description:
Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
Split-mixed Isophane (NPH) + Regular insulin twice daily
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: mg/dl
Day 1 213  (76) 188  (61)
Day 2 220  (61) 206  (71)
Day 3 180  (80) 207  (86)
Day 4 158  (44) 211  (63)
Day 5 124  (41) 190  (45)
3.Secondary Outcome
Title Mean Blood Glucose Concentration in mg/dL While on the Insulin Drip Among the 2 Groups
Hide Description To determine the differences in glycemic control as measured by differences in the mean daily blood glucose levels between treatment groups (insulin drip with regular insulin vs glulisine insulin) during the acute phase of diabetic ketoacidosis(DKA) before transitioning to subcutaneous insulin. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.
Time Frame up to 20 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine (Lantus) + Glulisine NPH + Regular
Hide Arm/Group Description:
Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
Split-mixed NPH + Regular insulin twice daily
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: mg/dL
153  (61) 185  (58)
4.Secondary Outcome
Title Difference in Time in Hours to Resolution of DKA Between the 2 Groups
Hide Description The mean duration of treatment until resolution of ketoacidosis is measured and compared between the 2 groups. The DKA was considered resolved when blood glucose was 250 mg/dl, the serum bicarbonate level was <18 mmol/l, and venous phenol hydroxylase (pH) was 7.30. The results were obtained from the citation Umpierrez GE, Jones S, Smiley D, Mulligan P, Keyler T, Temponi A, Semakula C, Umpierrez D, Peng L, Cerón M, Robalino G. Insulin analogs versus human insulin in the treatment of patients with diabetic ketoacidosis: a randomized controlled trial. Diabetes Care. 2009 Jul;32(7):1164-9. doi: 10.2337/dc09-0169. Epub 2009 Apr 14. PubMed ID: 19366972.
Time Frame up to 20 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Glargine (Lantus) + Glulisine NPH + Regular
Hide Arm/Group Description:
Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
Split-mixed NPH + Regular insulin twice daily
Overall Number of Participants Analyzed 34 34
Mean (Standard Deviation)
Unit of Measure: hours
8.9  (4.7) 10.5  (6.3)
Time Frame The adverse event data are collected from the time of admission to day 5 after the resolution of diabetic ketoacidosis (DKA).
Adverse Event Reporting Description For this study the adverse events of interest were hypoglycemia events where glucose levels are <70 mg/dL and severe hypoglycemia events with glucose level <40 mg/dL. The events were collected from rom the time of admission to day 5 after the resolution of diabetic ketoacidosis (DKA). The rest of the treatments for the patients was standard of care treatment.
 
Arm/Group Title Glargine (Lantus) + Glulisine NPH + Regular
Hide Arm/Group Description Daily insulin glargine (Lantus) + glulisine (Apidra) before meals Split-mixed NPH + Regular insulin twice daily
All-Cause Mortality
Glargine (Lantus) + Glulisine NPH + Regular
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/36 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Glargine (Lantus) + Glulisine NPH + Regular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/38 (2.63%)      2/36 (5.56%)    
Endocrine disorders     
Severe Hypoglycemia  [1]  1/38 (2.63%)  1 2/36 (5.56%)  2
Indicates events were collected by systematic assessment
[1]
Severe hypoglycemia is defined as blood glucose level < 40 mg/dL that required immediate invasive intervention
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Glargine (Lantus) + Glulisine NPH + Regular
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/38 (13.16%)      14/36 (38.89%)    
Endocrine disorders     
Hypoglycemia  [1]  5/38 (13.16%)  8 14/36 (38.89%)  26
Indicates events were collected by systematic assessment
[1]
Hypoglycemia is defined as blood glucose level <70 mg/dL
The study included relatively small number of patients. The study also excluded patients with hypovolemic shock, comatose patients and patients who had acute myocardial ischemia, congestive heart failure, end-stage renal or hepatic failure..
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Guillermo Umpierrez
Organization: Emory University SOM
Phone: 4047781663
Responsible Party: Guillermo Umpierrez, MD, Emory University
ClinicalTrials.gov Identifier: NCT00590044     History of Changes
Other Study ID Numbers: IRB00005062a
First Submitted: December 28, 2007
First Posted: January 10, 2008
Results First Submitted: January 30, 2009
Results First Posted: April 30, 2009
Last Update Posted: September 26, 2018