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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842894
• Other study ID #: NN304-3716
• Status: Completed
• Phase: N/A
• First received: February 11, 2009
• Last updated: August 13, 2014
• Start date: May 2009
• Est. completion date: October 2010

Study information

• Verified date: November 2012
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Macedonia, The Former Yugoslav Republic of: Drug Agency, Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3421
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• insulin detemir
Safety and effectiveness data collection in connection with the use of the drug.
• biphasic insulin aspart 30
Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Macedonia, The Former Yugoslav Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of serious adverse drug reactions (SADRs)		after 26 weeks	Yes
Secondary	Number of all minor hypoglycaemic events		during 4 weeks preceding each visit	Yes
Secondary	Number of all major hypoglycaemic events		during 13 weeks preceding each visit	Yes
Secondary	HbA1c		after 26 weeks	No
Secondary	Percentage of subjects to reach HbA1c below 7.0%		after 13 weeks and 26 weeks	No
Secondary	The effect on glycaemic control as measured by FPG (fasting plasma glucose)		after 13 weeks and 26 weeks	No
Secondary	The effect on glycamic control as measured by PG profile		after 13 weeks and 26 weeks	No
Secondary	Change in body weight		after 13 weeks and 26 weeks	No

External Links

•   Clinical Trials at Novo Nordisk