Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes

Novo Nordisk A/S243 enrolled

Overview

This study is conducted in Europe. The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

Study Type

OBSERVATIONAL

Enrollment

243

Conditions

Diabetes 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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Any patient with diabetes type 2 diabetes * Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin * Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient Exclusion Criteria: * Known or suspected allergy to study product(s) or related products * Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months

Locations (2)

Novo Nordisk Investigational Site

Rud, Norway

Novo Nordisk Investigational Site

Farsta, Sweden

Outcomes

Primary Outcomes

Incidence of serious adverse drug reactions, including major hypoglycaemic events

Time frame: after 12 and 26 weeks

Secondary Outcomes

Number of all hypoglycaemic events

Time frame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks

Number of all adverse drug reactions

Time frame: after 12 and 26 weeks

HbA1c

Time frame: at 12 and 26 weeks

Variability in fasting plasma glucose (FPG) values and average FPG levels

Time frame: at visits at 12 and 26 weeks

Weight changes

Time frame: at visits at 12 and 26 weeks

Data from ClinicalTrials.gov

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