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

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00655200

NN304-3525

Details and patient eligibility

About

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.

Enrollment: 2,286 patients

Sex: All

Ages: Under 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,286 participants in 1 patient group

A

Treatment:

Drug: insulin detemir