NCT00715663CompletedNot Applicable
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 1,584
- Locations
- 1
- Primary Endpoint
- Change in HbA1c
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
A
Intervention: biphasic insulin aspart 30 (Drug)
Outcomes
Primary Outcomes
Change in HbA1c
Time Frame: after 12 weeks of therapy
Change in post-prandial glucose (PPG)
Time Frame: after 12 weeks of therapy
Change in fasting plasma glucose (FPG)
Time Frame: after 12 weeks of therapy
Change in prandial glucose increment (PGI)
Time Frame: after 12 weeks of therapy
Incidence of hypoglycaemia and other adverse drug reaction
Time Frame: after 12 weeks of therapy
Patient and doctor's convenience
Time Frame: after 12 weeks of therapy
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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