Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00700765

Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using 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:	Cohort, Prospective
Official Title:	Observational, Safety Study in Subjects Using Levemir® (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 adverse drug reactions (SADRs) [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Major hypoglycaemic events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of serious adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Number of all adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Number of all hypoglycaemic events [ Time Frame: the last 4 weeks of treatment ] [ Designated as safety issue: Yes ]
Weight changes [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]
HbA1c [ Time Frame: after 12 weeks and 26 weeks of treatment ] [ Designated as safety issue: No ]
Variability in fasting blood glucose (FBG) and average plasma glucose level [ Time Frame: after 12 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1500
Study Start Date:	January 2008
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: insulin detemir For study drug, start dose and frequency of administration to be prescribed by the physician as a result of 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

Any subject with type 1 or type 2 diabetes who is prescribed insulin detemir at the physician's discretion

Criteria

Inclusion Criteria:

Type 1 or type 2 diabetes mellitus

Exclusion Criteria:

Subjects who are unlikely to comply with the protocol
Subjects who are currently being treated with Levemir®
Subjects who previously were enrolled into the study
Subjects with hypersensitivity to Levemir® or any of its excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00700765

Locations

Indonesia

Jakarta, Indonesia, 12520

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Sri I Soetomo, MD

Novo Nordisk Indonesia

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:	NN304-3528
Study First Received:	June 18, 2008
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00700765
Health Authority:	Indonesia: National Agency of Drug and Food Control

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