Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— EFFECTIVE  

Official title:

EFFicacious glycaEmia Control, Treatment Goal achIevement Very simplE With NovoMix 30: A Single-country, Multicentre, Prospective, Open Label, Non-controlled, Observational, 26-week Study in Serbian Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Diabetes Mellitus in Everyday Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699179
• Other study ID #: BIASP-3557
• Status: Completed
• Phase: N/A
• First received: June 13, 2008
• Last updated: October 27, 2016
• Start date: June 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Medicines and Medical Devices Agency of Serbia
• Study type: Observational

Clinical Trial Summary

This study is conducted in Europe. This observational study is aimed to reflect the post-authorisation experience with insulin analogue (biphasic insulin aspart 30) when used under normal clinical practice conditions in Serbia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2308
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Type 1 or Type 2 Diabetes Mellitus inadequately controlled on human insulin therapy lasting for at least 6 months

• HbA1c greater than 7%

• Informed Consent

Exclusion Criteria:

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

• Other limiting conditions specified in the locally approved NovoMix 30 SPC ( Summary of Product Characteristics), PIL ( Patient Information Leaflet).

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
There is no intervention in this trial. The trial is prepared to be non-interventional one. Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation.

Locations

Country	Name	City	State
Former Serbia and Montenegro	Novo Nordisk Investigational Site	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Former Serbia and Montenegro, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline		After 6 months	No
Secondary	Percentage of patients achieving HbA1c below 7,5% for Type 1 Diabetes Mellitus, below 7.0% and below or equal to 6.5% for Type 2 Diabetes Mellitus		after 12 weeks and 26 weeks compared to baseline	No
Secondary	Change in FPG (glucose variability)		after 12 weeks and 26 weeks compared to baseline	No
Secondary	Change in PPG (postprandial control)		after 12 weeks and 26 weeks compared to baseline	No
Secondary	Change in insulin dose and number of injections		at 12 weeks and 26 weeks of treatment	No
Secondary	Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study		after 12 weeks and 26 weeks of treatment compared to baseline	No
Secondary	Change in body weight and waist circumference		at 12 weeks and 26 weeks of treatment compared to baseline	No
Secondary	Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits		at 12 weeks and 26 weeks of treatment compared to baseline	Yes
Secondary	Number of adverse drug reactions (ADR)		after 12 weeks and 26 weeks of treatment	Yes

External Links

•   Clinical Trials at Novo Nordisk