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

Sponsor:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00697450

Purpose

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

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: insulin detemir

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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	200
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir Start dose, frequency of dosing, dose titration to be prescribed by the physician as a result of a normal clinical evaluation

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Type 2 diabetics

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697450

Locations

Czech Republic

Prague, Czech Republic, 16000

Sponsors and Collaborators

Novo Nordisk

Investigators

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

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-3560
Study First Received:	June 11, 2008
Last Updated:	October 20, 2009
ClinicalTrials.gov Identifier:	NCT00697450 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on November 09, 2009