Observational Study on the Effect of NovoMix® 30, Levemir® or NovoRapid® (Alone or Combined) in Type 2 Diabetics Previously Treated With Anti-diabetic Medication

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin aspart; Drug: insulin detemir; Drug: biphasic insulin aspart

• Registration Number: NCT00869908
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Africa, Asia, South America and Europe. The aim of this observational study is to document the experience with the study insulins when used in routine clinical practice. After the physician's decision to start insulin treatment using NovoMix® 30, Levemir® or NovoRapid® (alone or combined), type 2 diabetics will be eligible to be included in this study at the physician's discretion

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-25
• Study First Posted: 2009-03-26
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-18
• Last Update Posted: 2017-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66726

Inclusion Criteria

• After the physician has taken the decision to use NovoMix®30, Levemir® or NovoRapid® (alone or combined), any subject with type 2 diabetes who is not treated with these insulins or who has started on these insulin within the last 4 weeks before inclusion into this study is eligible for the study.
• The selection of the subjects will be at the discretion of the individual physician.

Exclusion Criteria

• Subjects treated with NovoMix® 30, Levemir® or NovoRapid® (alone or in combination) for more than 4 weeks before inclusion into this study.
• Subjects who were previously enrolled in this study.
• Subjects with a hypersensitivity to NovoMix® 30, Levemir® or NovoRapid® or to any of the excipients.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	insulin aspart	-
A	biphasic insulin aspart	-
A	insulin detemir	-

Primary Outcome Measures

Name	Time	Method
Number of serious adverse drug reactions and major hypoglycaemic events reported as serious adverse drug reactions	at baseline, 12 weeks and 24 weeks

Secondary Outcome Measures

Name	Time	Method
Evaluate the prescribing patterns and choice of insulin analogues in routine clinical practice	at baseline, 12 weeks and 24 weeks
Change in number of hypoglycaemic events	at baseline, 12 weeks and 24 weeks
Change in HbA1c	at baseline, 12 weeks and 24 weeks
Change in FPG (Fasting Plasma Glucose)	at baseline, 12 weeks and 24 weeks
Change in PPG (postprandial glucose)	at baseline, 12 weeks and 24 weeks

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇷 Istanbul, Turkey