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

Tracking Information

First Received Date ^ICMJE

April 4, 2008

Last Updated Date

October 13, 2009

Start Date ^ICMJE

February 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00655200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Diabetes Mellitus

Intervention ^ICMJE

Drug: insulin detemir

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

3299

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Philippines

Administrative Information

NCT ID ^ICMJE

NCT00655200

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-3525

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Dixie Pritzel C. Calpatura

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP