Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin

Novo Nordisk A/S611 enrolled

Overview

This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

Study Type

OBSERVATIONAL

Enrollment

611

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

biphasic insulin aspart 50DRUG

Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

biphasic insulin aspart 70DRUG

Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes mellitus Exclusion Criteria: * Known or suspected allergy to study product or related products. * Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.

Locations (2)

Novo Nordisk Investigational Site

Brussels, Belgium

Novo Nordisk Investigational Site

Luxembourg, Luxembourg

Outcomes

Primary Outcomes

The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.

Time frame: At baseline, 12 and 26 weeks.

Secondary Outcomes

Number of all hypoglycaemic episodes.

Time frame: At baseline, 12 and 26 weeks.

Number of all adverse drug reactions.

Time frame: At baseline, 12 and 26 weeks.

HbA1c

Time frame: at 12 and 26 weeks

Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels

Time frame: at 12 and 26 weeks

Weight changes

Time frame: at 12 and 26 weeks

Data from ClinicalTrials.gov

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