Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics - Tabular View

Tracking Information

First Received Date ^ICMJE

June 11, 2008

Last Updated Date

January 8, 2010

Start Date ^ICMJE

July 2008

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

weight effect [ Time Frame: 12 months prior to and 12 months after detemir treatment. ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00697450 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Improvement in FPG levels [ Time Frame: 12 months prior and 12 months after detemir treatment ] [ Designated as safety issue: No ]
Improvement in HbA1c levels [ Time Frame: 12 months prior and 12 months after detemir treatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Observational Study on the Weight Effect of Insulin Detemir (Levemir®) in Type 2 Diabetics

Official Title ^ICMJE

Observational Study Evaluating the Body Weight Progress During the Treatment With Insulin Detemir (Levemir®) in Type 2 Patients, Previously Treated With Other Basal Insulins

Brief Summary

This study is conducted in Europe. Observational study evaluating the body weight progress during the treatment with insulin detemir (Levemir®) in Type 2 patients, previously treated with other basal insulins

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: insulin detemir

Start dose, frequency of dosing, dose titration to be prescribed by the physician as a result of a normal clinical evaluation

Other Name: Levemir®)

Study Arms / Comparison Groups

Intervention: Drug: insulin detemir

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

206

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Type 2 diabetes
Current treatment with insulin NPH or glargine
The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

Current treatment with insulin detemir
Previous enrolment in this study
Hypersensitivity to insulin detemir or to any of the excipients.
Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Czech Republic

Administrative Information

NCT ID ^ICMJE

NCT00697450

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-3560

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Karel Rychna, MD	Novo Nordisk s.r.o.
Study Director:	Dana Raabova, MD	Novo Nordisk s.r.o.

Information Provided By

Novo Nordisk

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP