Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Biphasic Insulins; Insulin; Insulin Aspart; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin degludec, insulin aspart drug combination; Insulin Detemir; Insulin, Globin Zinc; Insulin, Isophane; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion Criteria:

• Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit

• Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir

• Subjects who were previously enrolled in this study

• Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients

• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months