Clinical trial NCT00834262: Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients
Official title: A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-02-03
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30, NovoMix® 50 or NovoMix® 70 or combinations, will be eligible A nonrandomized sample of approximately 325 subjects with Type 2 diabetes mellitus will be enrolled.

Brief summary: This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.


Eligibility criteria: Inclusion Criteria:

* Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion Criteria:

* Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
* Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.

Primary outcomes:
measure: Number of all hypoglycaemic episodes
timeFrame: during 13 weeks of treatment
Secondary outcomes:
measure: Number of adverse drug reactions
timeFrame: during 13 weeks of treatment
measure: Number of adverse events
timeFrame: during 13 weeks of treatment
measure: Number of all major hypoglycaemic (daytime and nocturnal) episodes
timeFrame: during 13 weeks of treatment
measure: Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes
timeFrame: during 13 weeks of treatment
measure: Number of major hypoglycaemic episodes related to omission of a meal after injection
timeFrame: during 13 weeks of treatment
measure: Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration
timeFrame: during 13 weeks of treatment
measure: Weight (BMI) change
timeFrame: at the end of the study after 13 weeks of treatment
measure: HbA1c change
timeFrame: at the end of the study after 13 weeks of treatment
measure: Percentage of patients reaching the target of HbA1c of 7.0% or less
timeFrame: at the end of the study after 13 weeks of treatment
measure: Variability in fasting blood glucose values and average (mean) fasting blood glucose level
timeFrame: at the end of the study after 13 weeks of treatment
measure: Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level
timeFrame: at the end of the study after 13 weeks of treatment
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: