Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00715663
Enrollment
1584
Registered
2008-07-15
Start date
2007-02-28
Completion date
2007-12-31
Last updated
2016-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Systems, Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGbiphasic 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

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frame
Patient and doctor's convenienceafter 12 weeks of therapy
Change in prandial glucose increment (PGI)after 12 weeks of therapy
Incidence of hypoglycaemia and other adverse drug reactionafter 12 weeks of therapy
Change in HbA1cafter 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

Secondary

MeasureTime frame
Patient satisfaction on devicesafter 12 weeks of treatment
Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practiceFor the duration of the study

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026