Observational Study of NovoMix® 50 for Treatment of Type 2 Diabetics for 12 Months

A Prospective, Multicentre, Open Label, Un-controlled , Observational, 12-month Study in Subjects Using: NovoMix® 50 (Biphasic Insulin Aspart 50) for Treatment of Type 2 Diabetes Mellitus in Slovenia

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00755833

Enrollment

270

Registered

2008-09-19

Start date

2008-09-30

Completion date

2010-04-30

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 2

Brief summary

This study is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control when using NovoMix® 50 up to 12 months after initiation subjects with type 2 diabetes currently on a therapy with human biphasic insulin. An additional objective is also to observe the different regimes of starting and maintaining the treatment with NovoMix® 50 during one year.

Interventions

DRUGbiphasic insulin aspart 50

Efficacy and safety data collection in connection with the use of the drug NovoMix® 50 in daily clinical practice.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Type 2 diabetes treated with biphasic human insulin with or without metformin * Inadequate glycaemic control or is experiencing hypoglycaemic events or would, in the physician's opinion, benefit from treatment with NovoMix® 50

Exclusion criteria

* Subjects with diagnosed type 1 diabetes mellitus * Subjects treated with short acting or intermediate acting human insulin or any insulin analogue * Subjects who are unlikely to comply with study description, e.g. uncooperative attitude, inability to come for regular visits * Subjects with a hypersensitivity to biphasic insulin aspart 50 (NovoMix® 50 )or to any of the excipients * Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 months

Design outcomes

Primary

Measure	Time frame
Change in HbA1c	At 0, 3, 6, 9, 12 months

Secondary

Measure	Time frame
Change in FPG (fasting plasma glucose)	At 0, 3, 6, 9, 12 months
Change in PPG (postprandial glucose)	At 0, 3, 6, 9, 12 months
Change in number of hypoglycaemic events	At 0, 3, 6, 9, 12 months
Percentage of subjects achieving target HbA1c	At 0, 3, 6, 9, 12 months
Dose and number of injections	At 0, 3, 6, 9, 12 months
Number of ADRs (adverse drug reaction)	At 0, 3, 6, 9, 12 months
Change in insulin presentation	At 0, 3, 6, 9, 12 months

Countries

Slovenia

Outcome results

None listed

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