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

This study has been completed.

Study NCT00590044 Information provided by Emory University

First Received: December 28, 2007 Last Updated: May 18, 2009 History of Changes

Study Type:	Interventional
Study Design:	Randomized, Open Label, Parallel Assignment
Condition:	Diabetic Ketoacidosis
Interventions:	Drug: insulin glargine+ glulisine Drug: NPH + Regular insulin

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
1	Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
2	Split-mixed NPH + Regular insulin twice daily

Participant Flow: Overall Study

	1	2
STARTED	38	36
COMPLETED	34	34
NOT COMPLETED	4	2
Withdrawal by Subject	2	2
wrong insulin arm assigned	1	0
Protocol Violation	1	0

Baseline Characteristics

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Reporting Groups

	Description
1	Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
2	Split-mixed NPH + Regular insulin twice daily

Baseline Measures

	1	2	Total
Number of Participants [units: participants]	38	36	74
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	38	36	74
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	39 ± 12	38 ± 12	38.5 ± 12
Gender [units: participants]
Female	14	12	26
Male	24	24	48
Region of Enrollment [units: participants]
United States	38	36	74

Outcome Measures

1. Primary:

Mean Daily Blood Glucose Concentration After the Resolution of DKA [ 1 year ]

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Measure Type	Primary
Measure Title	Mean Daily Blood Glucose Concentration After the Resolution of DKA
Measure 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.
Time Frame	1 year
Safety Issue	No

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.
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Reporting Groups

	Description
1	Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
2	Split-mixed NPH + Regular insulin twice daily

Measured Values

	1	2
Number of Participants Analyzed [units: participants]	34	34
Mean Daily Blood Glucose Concentration After the Resolution of DKA [units: mg/dl] Mean ± Standard Deviation	124 ± 41	190 ± 45

No statistical analysis provided for Mean Daily Blood Glucose Concentration After the Resolution of DKA

Serious Adverse Events

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Other Adverse Events

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More Information

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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.

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
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Results Point of Contact:

Name/Title: Guillermo Umpierrez
Organization: Emory University SOM
phone: 4047781663
e-mail: geumpie@emory.edu

No publications provided

Responsible Party:	Emory Univ SOM ( Guillermo Umpierrez, MD/Principal Investigator )
Study ID Numbers:	790-2006
Study First Received:	December 28, 2007
Results First Received:	January 30, 2009
Last Updated:	May 18, 2009
ClinicalTrials.gov Identifier:	NCT00590044 History of Changes
Health Authority:	United States: Institutional Review Board