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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 episodes

Number 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

Page last updated: August 23, 2015

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