Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes

Novo Nordisk A/S1,068 enrolled

Overview

This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.

Study Type

OBSERVATIONAL

Enrollment

1,068

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30 * Patient who signed on informed consent form Exclusion Criteria: * Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit * Patients who were previously enrolled in this study * Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Locations (1)

Novo Nordisk Investigational Site

Seoul, South Korea

Outcomes

Primary Outcomes

HbA1c change

Time frame: at the end of study after 26 weeks

Secondary Outcomes

Number of serious adverse drug reactions

Time frame: during the study

Number of serious adverse events

Time frame: during the study

Number of all major (daytime and nocturnal) hypoglycaemic events

Time frame: during the study

Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection

Time frame: during the study

Number of major hypoglycaemic events related to physical exercise of at least 30 min

Time frame: during the study

Number of all minor (daytime and nocturnal) hypoglycaemic events

Time frame: during the study

Weight (BMI) change

Time frame: at the end of study after 26 weeks

Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change

Time frame: at the end of study after 26 weeks

Percentage of patients reaching the target of HbA1c below or equal to 6.5%

Time frame: at the end of study after 26 weeks

Percentage of patients reaching the target of HbA1c below or equal to 7.0%

Time frame: at the end of study after 26 weeks

Data from ClinicalTrials.gov

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