Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes
Information source: Novo Nordisk A/S
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes; Diabetes Mellitus, Type 2
Intervention: biphasic insulin aspart 30 (Drug)
Phase: N/A
Status: Completed
Sponsored by: Novo Nordisk A/S Official(s) and/or principal investigator(s): Maciej Nazar, Study Director, Affiliation: Novo Nordisk Pharma Sp.z.o.o
Summary
This study is conducted in Europe. The aim of this study is to evaluate the safety and
efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2
diabetes with the aim of intensifying their treatment.
Clinical Details
Official title: Multicenter, Open Label, Non-randomized, Non-interventional Observational Study of Safety of Treatment Initiation With a Biphasic Insulin Aspart (NovoMix® 30) in Hospitalized Patients With Type 2 Diabetes Mellitus
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Frequency of severe hypoglycaemic episodes
Secondary outcome: Number of severe hypoglycaemic episodesNumber of mild hypoglycaemic episodes Postprandial glucose concentration after breakfast, lunch, and dinner Average fasting glucose concentration after waking and before main meals Average plasma glucose level at bedtime and at night
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with type 2 diabetes
- Treated with oral anti-diabetics and/or human insulin
Exclusion Criteria:
- Persons previously included in the trial
- Hypersensitive to biphasic insulin aspart or any of the excipients
- Pregnant or lactating women, or those who plan to get pregnant within the next 12
months
Locations and Contacts
Warszawa PL-02-274, Poland
Additional Information
Clinical Trials at Novo Nordisk
Starting date: January 2007
Last updated: March 29, 2012
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