A Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00738153

Purpose

This observational study is conducted in Africa.

The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.

Condition	Intervention
Diabetes Mellitus	Drug: insulin detemir

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

The incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of serious adverse events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]
Number of all adverse events [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]
Number of all hypoglycaemic events [ Time Frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks. ] [ Designated as safety issue: No ]
Weight changes [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: at the end of study ] [ Designated as safety issue: No ]
Sub -group analysis of hypo risk [ Time Frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	June 2008
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Any subject with type 1 or type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before

Criteria

Inclusion Criteria:

Any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician

Exclusion Criteria:

Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
Currently being treated with insulin detemir
Previously enrolled in this study
Hypersensitivity to insulin detemir or to any of the excipients
Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738153

Locations

Morocco

Rabat, Morocco, 20000

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Zakia By, MBA

Novo Nordisk Pharma S.A.S

More Information

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-3536
Study First Received:	August 19, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00738153
Health Authority:	Morocco: Ministry of health

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009