Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00675493

Enrollment

942

Registered

2008-05-09

Start date

2008-05-31

Completion date

2009-01-31

Last updated

2016-02-19

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 trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.

Interventions

DRUGbiphasic insulin aspart 30

Start dose and frequency 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

10 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion criteria

* Subjects currently being treated with biphasic insulin aspart 30 * Subjects who were previously enrolled in this study * Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients * Women who are pregnant or have the intention of becoming pregnant within next 6 months * Children below 10 years of age

Design outcomes

Primary

Measure	Time frame
Change in HbA1c from baseline	For the duration of the study

Secondary

Measure	Time frame
Change in FPG (glucose variability)	after 12 weeks and 24 weeks of treatment
Change in PPG (postprandial control)	after 12 weeks and 24 weeks of treatment
Change in insulin dose and number of injections	at 12 weeks and 24 weeks of treatment
Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%	after 12 weeks and 24 weeks of treatment
Change in body weight	at 12 weeks and 24 weeks of treatment
Change in number of hypoglycaemic events	during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment
Number of adverse drug reactions (ADR)	after 12 weeks and 24 weeks of treatment
Change in oral antidiabetic drug therapy	after 12 weeks and 24 weeks of treatment

Countries

Romania

Outcome results

None listed

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