Clinical trial NCT00737776: Observational Study on Efficacy and Safety in Patients Using NovoMix® 30 for the Treatment of Diabetes
Official title: NovoMix® 30 UPGRADE (NovoMix® 30 Use for Progressed Glycemic Control in Realistic Administration to DiabEtes Mellitus): A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Efficacy and Safety Study in Patients Using Biphasic Insulin Aspart 30 (NovoMix® 30) for the Treatment of Diabetes Mellitus
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: 2008-08-20
Enrollment: 1068
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with type 1 and type 2 diabetes who are prescribed with NovoMix® 30

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the efficacy on blood glucose control while using NovoMix® 30 FlexPen® under normal clinical practice conditions in Korea. A clinical safety profile will be also evaluated.


Eligibility criteria: Inclusion Criteria:

* Any patient with type 1 and type 2 diabetes who are treated with NovoMix® 30
* Patient who signed on informed consent form

Exclusion Criteria:

* Patients who are unlikely to comply with protocol requirements, e.g., uncooperative attitude, inability to return for the final visit
* Patients who were previously enrolled in this study
* Patients with a hypersensitivity to NovoMix® 30 or to any of the excipients
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months

Primary outcomes:
measure: HbA1c change
timeFrame: at the end of study after 26 weeks
Secondary outcomes:
measure: Number of serious adverse drug reactions
timeFrame: during the study
measure: Number of serious adverse events
timeFrame: during the study
measure: Number of all major (daytime and nocturnal) hypoglycaemic events
timeFrame: during the study
measure: Number of major hypoglycaemic events related to omission of a meal after NovoMix® 30 injection
timeFrame: during the study
measure: Number of major hypoglycaemic events related to physical exercise of at least 30 min
timeFrame: during the study
measure: Number of all minor (daytime and nocturnal) hypoglycaemic events
timeFrame: during the study
measure: Weight (BMI) change
timeFrame: at the end of study after 26 weeks
measure: Lipid profile (Total cholesterol, LDL, HDL, Triglyceride) change
timeFrame: at the end of study after 26 weeks
measure: Percentage of patients reaching the target of HbA1c below or equal to 6.5%
timeFrame: at the end of study after 26 weeks
measure: Percentage of patients reaching the target of HbA1c below or equal to 7.0%
timeFrame: at the end of study after 26 weeks
measure: Percentage of patients reaching the physician's own target recommendation
timeFrame: at the end of study after 26 weeks
measure: Variability in fasting plasma glucose values and average (mean) fasting plasma glucose level
timeFrame: at the end of study after 26 weeks
measure: Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) plasma glucose level
timeFrame: at the end of study after 26 weeks
measure: Diabetes Fear of Self-Injection Questionnaire (D-FISQ)
timeFrame: at the end of study after 26 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: