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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834262
• Other study ID #: BIASP-3669
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: October 27, 2016
• Start date: April 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 339
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• biphasic insulin aspart 50
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
• biphasic insulin aspart 70
Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Locations

Country	Name	City	State
Israel	Novo Nordisk Investigational Site	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of all hypoglycaemic episodes		during 13 weeks of treatment	Yes
Secondary	Number of adverse drug reactions		during 13 weeks of treatment	Yes
Secondary	Number of adverse events		during 13 weeks of treatment	Yes
Secondary	Number of all major hypoglycaemic (daytime and nocturnal) episodes		during 13 weeks of treatment	Yes
Secondary	Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes		during 13 weeks of treatment	Yes
Secondary	Number of major hypoglycaemic episodes related to omission of a meal after injection		during 13 weeks of treatment	Yes
Secondary	Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration		during 13 weeks of treatment	Yes
Secondary	Weight (BMI) change		at the end of the study after 13 weeks of treatment	Yes
Secondary	HbA1c change		at the end of the study after 13 weeks of treatment	No
Secondary	Percentage of patients reaching the target of HbA1c of 7.0% or less		at the end of the study after 13 weeks of treatment	No
Secondary	Variability in fasting blood glucose values and average (mean) fasting blood glucose level		at the end of the study after 13 weeks of treatment	No
Secondary	Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level		at the end of the study after 13 weeks of treatment	No

External Links

•   Clinical Trials at Novo Nordisk