NCT00699179
Completed
Not Applicable
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
Interventionsbiphasic insulin aspart 30
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 2,308
- Locations
- 1
- Primary Endpoint
- Change in HbA1c from baseline
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A
Intervention: biphasic insulin aspart 30 (Drug)
Outcomes
Primary Outcomes
Change in HbA1c from baseline
Time Frame: After 6 months
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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