Status:

COMPLETED

Observational Study to Evaluate the Safety of NovoMix® 30 FlexPen®

Lead Sponsor:

Novo Nordisk A/S

Conditions:

Diabetes

Diabetes Mellitus, Type 2

Eligibility:

All Genders

Brief Summary

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 30 FlexPen® under normal clinical practice conditions.

Eligibility Criteria

Inclusion

  • Type 2 diabetes having failed on basal insulin with or without OAD
  • HbA1c greater than 7.0%

Exclusion

  • Subjects being unlikely to comply with protocol requirements
  • Subjects who previously enrolled in this study
  • Subjects with hypersensitivity to biphasic insulin aspart or any of the excipients
  • Women who are pregnant, breast feeding and women in child bearing capacity who are not using reliable contraceptive method

Key Trial Info

Start Date :

May 1 2008

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

May 1 2009

Estimated Enrollment :

216 Patients enrolled

Trial Details

Trial ID

NCT00709683

Start Date

May 1 2008

End Date

May 1 2009

Last Update

March 7 2016

Active Locations (1)

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Tunisia, Tunisia, 1053