Observational Study to Evaluate the Safety of Levemir® in Diabetes

Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00706017

Acronym

PREDICTIVE™

Enrollment

2282

Registered

2008-06-27

Start date

2007-09-30

Completion date

2008-07-31

Last updated

2016-10-28

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 observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Interventions

DRUGinsulin detemir

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Type 1 or 2 diabetes * Including newly diagnosed not on insulin or insulin analogue treatment * Selection at the discretion of the physician * Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion criteria

* Current treatment with Levemir® * Previously enrolled in the study * Hypersensitivity to Levemir®

Design outcomes

Primary

Measure	Time frame
Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)	during treatment

Secondary

Measure	Time frame
Glucose control measures	during treatment
Weight	during treatment

Countries

Mexico

Outcome results

None listed

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