Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

This study has been completed.

First Received: April 4, 2008 Last Updated: December 10, 2008 History of Changes

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00655200

Purpose

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.

Condition	Intervention
Diabetes Mellitus	Drug: insulin detemir

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

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:

Safety profile of Insulin Detemir among Filipino patients [ Time Frame: 3 months follow-up visit ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	2286
Study Start Date:	February 2008
Study Completion Date:	September 2008
Primary Completion Date:	September 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

Patients with Type 1 and Type 2 Diabetes

Criteria

Inclusion Criteria:

Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
Newly diagnosed insulin naive patients
Patients currently on human insulin or on basal insulin
Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
Usage should be in accordance with the current prescribing information (See attached prescribing information)

Exclusion Criteria:

Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
Pregnant women, those planning to become pregnant, or women who are breastfeeding
Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
Children below 6 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655200

Locations

Philippines

Manila, Philippines, 1605

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Dixie Pritzel C. Calpatura

Novo Nordisk

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:	NN304-3525
Study First Received:	April 4, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00655200 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

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, Type 2
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on July 02, 2009