Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT00715663

Collaborator

(none)

1,584

Enrollment

Location

Duration (Months)

159.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is conducted in Asia. The aim of this observational study is to evaluate safety, efficacy and convenience in using NovoMix® 30 FlexPen® in type 2 diabetes under normal clinical practice conditions.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus, Type 2 Delivery Systems	Drug: biphasic insulin aspart 30

Study Design

Study Type:

Observational

Actual Enrollment :

1584 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multi-center, Prospective, Non-interventional Evaluation of Efficacy, Safety and Convenience of Using NovoMix® 30 FlexPen® as Monotherapy, or in Combination With OHA, in Treatment of Type 2 Diabetic Patients in Routine Clinical Practice: A Post-Marketing Surveillance Study

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
A	Drug: biphasic insulin aspart 30 No intervention is done. For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation Other Names: NovoMix® 30

Outcome Measures

Primary Outcome Measures

Change in HbA1c [after 12 weeks of therapy]
Change in post-prandial glucose (PPG) [after 12 weeks of therapy]
Change in fasting plasma glucose (FPG) [after 12 weeks of therapy]
Change in prandial glucose increment (PGI) [after 12 weeks of therapy]
Incidence of hypoglycaemia and other adverse drug reaction [after 12 weeks of therapy]
Patient and doctor's convenience [after 12 weeks of therapy]

Secondary Outcome Measures

Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice [For the duration of the study]
Patient satisfaction on devices [after 12 weeks of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients with type 2 diabetes, not adequately controlled on their current therapy, who were prescribed NovoMix® 30 FlexPen® as monotherapy, or in combination with OHA, in accordance with the approved labeling, are eligible for the survey.