Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

An Observational Study Evaluating the Safety and Efficacy of the Treatment With Biphasic Insulin Aspart (NovoMix® 30 FlexPen®) in the Treatment of Type 2 Diabetics After Failing on Basal/ Intermediate Mono or Combination Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00709683

Enrollment

216

Registered

2008-07-03

Start date

2008-05-31

Completion date

2009-05-31

Last updated

2016-03-07

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 Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Interventions

DRUGbiphasic insulin aspart 30

Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Type 2 diabetes having failed on basal insulin with or without OAD * HbA1c greater than 7.0%

Exclusion criteria

* Subjects being unlikely to comply with protocol requirements * Subjects who previously enrolled in this study * Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients * Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

Design outcomes

Primary

Measure	Time frame
Incidence of major hypoglycaemic events reported as serious adverse drug reactions	during 26 weeks of treatment

Secondary

Measure	Time frame
Number of serious adverse events	during 26 weeks of treatment
Number of all major (daytime and nocturnal) hypoglycaemic events	during 26 weeks of treatment
Number of all minor (daytime and nocturnal) hypoglycaemic events	during 26 weeks of treatment
Weight (BMI) change from baseline	At the end of the study
Number of serious adverse drug reactions	during 26 weeks of treatment
Percentage of patients reaching the target of HbA1c of less than or equal to 7.0%	At the end of the study
Average (mean) fasting plasma glucose level	At the end of the study
Average post-breakfast (90-120 mins), post-lunch (90-120 mins), post-dinner (90-120 mins) plasma glucose level	At the end of the study
HbA1c change from baseline	At the end of the study

Countries

Tunisia

Outcome results

None listed

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