Observational Study to Evaluate the Effectiveness and Safety of Levemir®, NovoMix® 30 and NovoRapid® in Insulin naïve Subjects With Type 2 Diabetes

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: insulin detemir; Drug: biphasic insulin aspart 30; Drug: insulin aspart

• Registration Number: NCT00771680
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Europe and Asia. The aim of this observational study is to evaluate the effectiveness and the incidence of serious adverse reactions while using Levemir®, NovoMix® and/or NovoRapid® in subjects with type 2 diabetes that have not used insulin previously under normal clinical practice conditions.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-09
• Study First Submitted QC: 2008-10-10
• Study First Posted: 2008-10-13
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10408

Inclusion Criteria

• Any insulin näive type 2 diabetic patient that able to use the drug as judged by the investigator

Exclusion Criteria

• In accordance with approved label

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 30	-
A	insulin detemir	-
A	insulin aspart	-

Primary Outcome Measures

Name	Time	Method
HbA1c	at baseline visit and during 3, 6, 9 and 12 months
Serious adverse drug reactions including major hypoglycaemic events	during 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
Number of all minor (daytime and nocturnal) hypoglycaemic events	During 4 weeks prior to each study visit
Number of all major (daytime and nocturnal) hypoglycaemic events	during 12 months of treatment
Number of serious adverse drug reactions	during 12 months of treatment
Weight (BMI) change	At 6 and 12 months
Variability in fasting blood glucose values and average (mean) fasting blood glucose level	At baseline visit and after 6 and 12 months treatment
Average post-prandial blood glucose level (2h after dinner)	At baseline visit and after 6 and 12 months treatment
Quality of Life (QoL) as assessed by patient questionnaire	At baseline and the end of 6 and 12 months treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇦 Kiev, Ukraine