Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30; Drug: biphasic insulin aspart 50; Drug: biphasic insulin aspart 70

• Registration Number: NCT00834262
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-02
• Study First Submitted QC: 2009-02-02
• Study First Posted: 2009-02-03
• Study Start: 2009-04
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 339

Inclusion Criteria

• Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion Criteria

• Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 50	-
A	biphasic insulin aspart 30	-
A	biphasic insulin aspart 70	-

Primary Outcome Measures

Name	Time	Method
Number of all hypoglycaemic episodes	during 13 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Number of adverse drug reactions	during 13 weeks of treatment
Number of all major hypoglycaemic (daytime and nocturnal) episodes	during 13 weeks of treatment
Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes	during 13 weeks of treatment
Weight (BMI) change	at the end of the study after 13 weeks of treatment
Percentage of patients reaching the target of HbA1c of 7.0% or less	at the end of the study after 13 weeks of treatment
Number of adverse events	during 13 weeks of treatment
Number of major hypoglycaemic episodes related to omission of a meal after injection	during 13 weeks of treatment
HbA1c change	at the end of the study after 13 weeks of treatment
Variability in fasting blood glucose values and average (mean) fasting blood glucose level	at the end of the study after 13 weeks of treatment
Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration	during 13 weeks of treatment
Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level	at the end of the study after 13 weeks of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇮🇱 Kfar Saba, Israel