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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Evaluation of Effectiveness and Safety of Levemir® (Insulin Detemir), NovoMix® (Biphasic Insulin Aspart) and/or NovoRapid® (Insulin Aspart) in Insulin naïve Subjects With Type 2 Diabetes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771680
• Other study ID #: INS-3655
• Status: Completed
• Phase: N/A
• First received: October 9, 2008
• Last updated: October 26, 2016
• Start date: October 2008
• Est. completion date: July 2010

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Federal Service for quality Control of Medical ProductsUkraine: Not required for observational study
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10408
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Start dose and frequency at the discretion of the physician following clinical practice
• biphasic insulin aspart 30
Start dose and frequency at the discretion of the physician following clinical practice
• insulin aspart
Start dose and frequency at the discretion of the physician following clinical practice

Locations

Country	Name	City	State
Russian Federation	Novo Nordisk Investigational Site	Moscow
Ukraine	Novo Nordisk Investigational Site	Kiev

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		at baseline visit and during 3, 6, 9 and 12 months	No
Primary	Serious adverse drug reactions including major hypoglycaemic events		during 12 months of treatment	Yes
Secondary	Number of serious adverse drug reactions		during 12 months of treatment	No
Secondary	Number of all major (daytime and nocturnal) hypoglycaemic events		during 12 months of treatment	Yes
Secondary	Number of all minor (daytime and nocturnal) hypoglycaemic events		During 4 weeks prior to each study visit	No
Secondary	Weight (BMI) change		At 6 and 12 months	No
Secondary	Variability in fasting blood glucose values and average (mean) fasting blood glucose level		At baseline visit and after 6 and 12 months treatment	No
Secondary	Average post-prandial blood glucose level (2h after dinner)		At baseline visit and after 6 and 12 months treatment	No
Secondary	Quality of Life (QoL) as assessed by patient questionnaire		At baseline and the end of 6 and 12 months treatment	No

External Links

•   Clinical Trials at Novo Nordisk