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

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT00699179
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-13
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2308

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c from baseline	After 6 months

Secondary Outcome Measures

Name	Time	Method
Change in body weight and waist circumference	at 12 weeks and 26 weeks of treatment compared to baseline
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
Change in FPG (glucose variability)	after 12 weeks and 26 weeks compared to baseline
Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits	at 12 weeks and 26 weeks of treatment compared to baseline
Change in PPG (postprandial control)	after 12 weeks and 26 weeks compared to baseline
Change in insulin dose and number of injections	at 12 weeks and 26 weeks of treatment
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
Number of adverse drug reactions (ADR)	after 12 weeks and 26 weeks of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; Belgrade, Former Serbia and Montenegro