Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: insulin detemir (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Dixie Pritzel C. Calpatura, Study Director, Affiliation: Novo Nordisk
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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.
Clinical Details
Official title: Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus
Study design: Cohort, Prospective
Primary outcome: Safety profile of Insulin Detemir among Filipino patients
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Manila 1605, Philippines; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: February 2008
Ending date: February 2009
Last updated: April 4, 2008
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