Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

Novo Nordisk A/S400 enrolled

Overview

This trial is conducted in Europe. The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

Study Type

OBSERVATIONAL

Enrollment

400

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

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

insulin detemirDRUG

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

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with Type 1 or Type 2 diabetes, including newly diagnosed * Age: Levemir® above 6 years * Age: Novomix® above 18 years Exclusion Criteria: * Current treatment with NovoMix® 30 or Levemir®

Locations (1)

Unnamed facility

Sarajevo, Bosnia and Herzegovina

Outcomes

Primary Outcomes

Glycaemic control as measured by HbA1c

Time frame: After 24 weeks

Secondary Outcomes

Percentage of subjects to reach HbA1c below 7.0% and =6.5%

Time frame: After 24 weeks

Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30

Time frame: After 24 weeks

The effect on glycamic control as measured by FPG

Time frame: After 24 weeks

The effect on glycamic control as measured by PG profile

Time frame: After 24 weeks

Change in body weight

Time frame: After 24 weeks

Data from ClinicalTrials.gov

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