Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT00737776
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-19
• Study First Posted: 2008-08-20
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1068

Inclusion Criteria

• Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
• Patient who signed on informed consent form

Exclusion Criteria

• Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
• Patients who were previously enrolled in this study
• Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
HbA1c change	at the end of study after 26 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of patients reaching the target of HbA1c below or equal to 6.5%	at the end of study after 26 weeks
Percentage of patients reaching the physician's own target recommendation	at the end of study after 26 weeks
Number of serious adverse drug reactions	during the study
Number of major hypoglycaemic events related to physical exercise of at least 30 min	during the study
Number of all minor (daytime and nocturnal) hypoglycaemic events	during the study
Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection	during the study
Weight (BMI) change	at the end of study after 26 weeks
Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change	at the end of study after 26 weeks
Percentage of patients reaching the target of HbA1c below or equal to 7.0%	at the end of study after 26 weeks
Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level	at the end of study after 26 weeks
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level	at the end of study after 26 weeks
Diabetes Fear of Self-Injection Questionnaire (D-FISQ)	at the end of study after 26 weeks
Number of serious adverse events	during the study
Number of all major (daytime and nocturnal) hypoglycaemic events	during the study

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇰🇷 Seoul, Korea, Republic of