Clinical trial NCT00699179: Observational Study to Evaluate the Efficacy and Safety of NovoMix® 30 in Type 1 and 2 Diabetes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-06-17
Enrollment: 2308
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and 2 diabetes

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: After 6 months
Secondary outcomes:
measure: 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
timeFrame: after 12 weeks and 26 weeks compared to baseline
measure: Change in FPG (glucose variability)
timeFrame: after 12 weeks and 26 weeks compared to baseline
measure: Change in PPG (postprandial control)
timeFrame: after 12 weeks and 26 weeks compared to baseline
measure: Change in insulin dose and number of injections
timeFrame: at 12 weeks and 26 weeks of treatment
measure: Change in oral antidiabetic drug therapy dosage and eventual discontinuation of oral antidiabetic drug therapy during the study
timeFrame: after 12 weeks and 26 weeks of treatment compared to baseline
measure: Change in body weight and waist circumference
timeFrame: at 12 weeks and 26 weeks of treatment compared to baseline
measure: Change in number of major hypoglycaemic events during 4 weeks proceeding routine visits
timeFrame: at 12 weeks and 26 weeks of treatment compared to baseline
measure: Number of adverse drug reactions (ADR)
timeFrame: after 12 weeks and 26 weeks of treatment
Other outcomes:
Locations:
city: Belgrade
country: Former Serbia and Montenegro
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: