Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

Novo Nordisk A/S2,308 enrolled

Overview

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

Study Type

OBSERVATIONAL

Enrollment

2,308

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months * HbA1c greater than 7% * Informed Consent Exclusion Criteria: * Patients with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients * Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet). * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next couple of months

Locations (1)

Novo Nordisk Investigational Site

Belgrade, Serbia and Montenegro

Outcomes

Primary Outcomes

Change in HbA1c from baseline

Time frame: After 6 months

Secondary Outcomes

Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus

Time frame: after 12 weeks and 26 weeks compared to baseline

Change in FPG (glucose variability)

Time frame: after 12 weeks and 26 weeks compared to baseline

Change in PPG (postprandial control)

Time frame: after 12 weeks and 26 weeks compared to baseline

Change in insulin dose and number of injections

Time frame: at 12 weeks and 26 weeks of treatment

Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study

Time frame: after 12 weeks and 26 weeks of treatment compared to baseline

Change in body weight and waist circumference

Time frame: at 12 weeks and 26 weeks of treatment compared to baseline

Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits

Time frame: at 12 weeks and 26 weeks of treatment compared to baseline

Number of adverse drug reactions (ADR)

Time frame: after 12 weeks and 26 weeks of treatment

Data from ClinicalTrials.gov

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