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NCT00715663 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00715663
Other study ID # NOPEN3-1891
Secondary ID
Status Completed
Phase N/A
First received July 14, 2008
Last updated December 12, 2016
Start date February 2007
Est. completion date December 2007

Study information
Verified date December 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Indonesia: National Agency of Drug and Food Control
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1584
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic 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

Locations
Country Name City State
Indonesia Novo Nordisk Investigational Site Jakarta

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Indonesia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c after 12 weeks of therapy No
Primary Change in post-prandial glucose (PPG) after 12 weeks of therapy No
Primary Change in fasting plasma glucose (FPG) after 12 weeks of therapy No
Primary Change in prandial glucose increment (PGI) after 12 weeks of therapy No
Primary Incidence of hypoglycaemia and other adverse drug reaction after 12 weeks of therapy Yes
Primary Patient and doctor's convenience after 12 weeks of therapy No
Secondary 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 No
Secondary Patient satisfaction on devices after 12 weeks of treatment No
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