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 on December 28, 2007. Last Updated on May 18, 2009 History of Changes

Results First Received: January 30, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
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 [ Time Frame: 1 year ]

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2. Secondary:

Mean Daily Blood Glucose Concentration While on the Insulin Drip [ Time Frame: blood glucose (BG) before meals and at bedtime ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Frequency of Hypoglycemia [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

4. Secondary:

Frequency of Hyperglycemia [ Time Frame: blood glucose (BG) before meals, at bedtime and as needed ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

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