Skip to main content
OpenTrials
Completed

NCT Number: NCT00715663

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Delivery Systems Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

biphasic insulin aspart 30

Drug

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

Primary outcomes

  1. Change in HbA1c

    Time frame: after 12 weeks of therapy

  2. Change in post-prandial glucose (PPG)

    Time frame: after 12 weeks of therapy

  3. Change in fasting plasma glucose (FPG)

    Time frame: after 12 weeks of therapy

  4. Change in prandial glucose increment (PGI)

    Time frame: after 12 weeks of therapy

  5. Incidence of hypoglycaemia and other adverse drug reaction

    Time frame: after 12 weeks of therapy

  6. Patient and doctor's convenience

    Time frame: after 12 weeks of therapy

Secondary outcomes

  1. Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practice

    Time frame: For the duration of the study

  2. Patient satisfaction on devices

    Time frame: after 12 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jul 15, 2008
Registry last updated
Dec 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.