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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 HbA1c

Change 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 practice

Patient 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

Page last updated: August 23, 2015

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