Observational Study to Evaluate the Safety While Using Levemir® - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00701155

Purpose

This study is conducted in Africa.

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

Condition	Intervention
Diabetes Mellitus	Drug: insulin detemir

MedlinePlus related topics: Diabetes Hypoglycemia

Drug Information available for: Insulin Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus.

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of serious ADRs incl. major hypoglycemias [ Time Frame: after 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of serious adverse events [ Time Frame: after 24 weeks ] [ Designated as safety issue: Yes ]
Number of all adverse events [ Time Frame: after 24 weeks ] [ Designated as safety issue: Yes ]
Weight changes [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
Subgroup analysis of hypoglycemias [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]
Number of all hypoglycemic events [ Time Frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks. ] [ Designated as safety issue: Yes ]
Variability in fasting Blood Sugar and average plasma glucose levels [ Time Frame: after 24 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	3621
Study Start Date:	July 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 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 actual clinical evaluation

Eligibility

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

Study Population

Type 1 or 2 diabetes patients

Criteria

Inclusion Criteria:

After the physician decision has been made to use insulin detemir, 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;
Subjects currently being treated with insulin detemir;
Subjects who previously enrolled in this study
Subjects with a 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. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00701155

Locations

Egypt

Giza, Egypt, 0020

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Sherif Waguih

NN Egypt

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:	NN304-1953
Study First Received:	June 13, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00701155 History of Changes
Health Authority:	Egypt: Ministry of Health and Population

Study placed in the following topic categories:

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

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009