Observational Study to Evaluate Safety, Efficacy and Convenience of Using NovoMix® 30 FlexPen® in Type 2 Diabetes
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems
Intervention: biphasic insulin aspart 30 (Drug)
Phase: N/A
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Sri Indriastuti Soetomo, MD, Study Director, Affiliation: Novo Nordisk Indonesia
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.
Clinical Details
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 design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Change in HbA1cChange in post-prandial glucose (PPG) Change in fasting plasma glucose (FPG) Change in prandial glucose increment (PGI) Incidence of hypoglycaemia and other adverse drug reaction Patient and doctor's convenience
Secondary outcome: Response of different patient profiles to NovoMix 30 therapy and patient profiles considered eligible for insulin treatment in physicians' routine clinical practicePatient satisfaction on devices
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Jakarta 12520, Indonesia
Additional Information
Clinical Trials at Novo Nordisk
Starting date: February 2007
Last updated: May 23, 2012
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