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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00655200
Enrollment
2286
Registered
2008-04-09
Start date
2008-02-29
Completion date
2008-09-30
Last updated
2023-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

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.

Interventions

DRUGinsulin detemir

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Safety profile of Insulin Detemir among Filipino patients3 months follow-up visit

Countries

Philippines

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026