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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc

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