Insulin Detemir and Waist Circumference

This study has been completed.

Sponsor:

Information provided by:

University of Roma La Sapienza

ClinicalTrials.gov Identifier:

NCT00714844

First received: July 7, 2008

Last updated: NA

Last verified: April 2008

History: No changes posted

Tracking Information
First Received Date ^ICMJE	July 7, 2008
Last Updated Date	July 7, 2008
Start Date ^ICMJE	January 2007
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Insulin Detemir and Waist Circumference
Official Title ^ICMJE	Waist Circumference Reduction After Insulin Detemir Treatment in Type 2 Diabetes Patients Previously Treated With NPH Insulin
Brief Summary	The purpose of the study is to investigate the weight-sparing effect of detemir and assess glycemic control and treatment satisfaction when switching from NPH to detemir, to improve metabolic control.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Type 2 diabetic patients accessing the Diabetologic Centre
Condition ^ICMJE	Type 2 Diabetes
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Mandosi E, Fallarino M, Rossetti M, Gatti A, Morano S. Waist circumference reduction after insulin detemir therapy in type 2 diabetes patients previously treated with NPH. Diabetes Res Clin Pract. 2009 May;84(2):e18-20. Epub 2009 Mar 17.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	20
Completion Date	October 2007
Primary Completion Date	October 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Duration of type 2 diabetes for at least 12 months BMI <40 kg/m2 HbA1c >7.5% Requiring basal insulin replacement and previously treated with NPH insulin
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00714844
Other Study ID Numbers ^ICMJE	PolUmbI-DptSClin-Det1
Has Data Monitoring Committee	No
Responsible Party	Susanna Morano, University of Roma La Sapienza, Policlinico Umberto I, Dpt Scienze Cliniche
Study Sponsor ^ICMJE	University of Roma La Sapienza
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Roma La Sapienza
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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