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

EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00699179

Acronym

EFFECTIVE

Enrollment

2308

Registered

2008-06-17

Start date

2008-06-30

Completion date

2009-09-30

Last updated

2016-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Brief summary

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.

Interventions

DRUGbiphasic insulin aspart 30

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline	After 6 months

Secondary

Measure	Time frame
Change in FPG (glucose variability)	after 12 weeks and 26 weeks compared to baseline
Change in PPG (postprandial control)	after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections	at 12 weeks and 26 weeks of treatment
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	after 12 weeks and 26 weeks compared to baseline
Change in body weight and waist circumference	at 12 weeks and 26 weeks of treatment compared to baseline
Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits	at 12 weeks and 26 weeks of treatment compared to baseline
Number of adverse drug reactions (ADR)	after 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	after 12 weeks and 26 weeks of treatment compared to baseline

Countries

Serbia and Montenegro

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026