Observational Study to Evaluate the Safety of Levemir® in Type 2 Diabetes

Novo Nordisk A/S18,481 enrolled

Overview

This study is conducted in Europe, North America and Asia. The aim of this observational study is to evaluate the safety and effectiveness while using Levemir® once daily in combination with oral antidiabetic drugs in type 2 diabetics during 24 weeks under normal clinical practice. Data from the NN304-3573 study (NCT00740519) will be pooled with data from this study and reported together in the final study report for this study.

Study Type

OBSERVATIONAL

Enrollment

18,481

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * After the participating physician's decision has been made to initiate once-daily Levemir® therapy, any patient with Type 2 diabetes who is currently treated with diet, exercise and one or more OADs can be offered to participate Exclusion Criteria: * Current treatment with insulin * Known or suspected allergy to Levemir® or excipients * Children below the age of 6 years * Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant within the next 6 months or are not using adequate contraceptive methods (contraceptive measures as required by local law or practice)

Locations (9)

Novo Nordisk Investigational Site

Mississauga, Canada

Novo Nordisk Investigational Site

Beijing, Beijing Municipality, China

Novo Nordisk Investigational Site

Mainz, Germany

Novo Nordisk Investigational Site

Kfar Saba, Israel

Outcomes

Primary Outcomes

Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemia

Time frame: during 24 weeks of treatment

Secondary Outcomes

Incidence of all adverse drug reactions (ADRs)

Time frame: during 24 weeks of treatment

Incidence of major and minor hypoglycaemic events

Time frame: in the 4 weeks preceding trial start, and at the 12 and 24 week visits

HbA1c and its change from trial start

Time frame: at the 12 and 24 week visits

Fasting blood glucose (FBG) (average of the self-monitored blood glucose measurements) and its change from trial start

Time frame: at the 12 and 24 week visits

FBG variability (measured as standard deviation of FBG) and its change from trial start

Time frame: at the 12 and 24 weeks visits

Body weight and its change from trial start

Time frame: at the 12 and 24 week visits

Data from ClinicalTrials.gov

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