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NCT01565733 Clinical Trial

Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01565733
Other study ID # BIASP-4017
Secondary ID
Status Completed
Phase N/A
First received March 26, 2012
Last updated October 27, 2016
Start date January 2007
Est. completion date July 2007

Study information
Verified date October 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2223
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.

Locations
Country Name City State
Poland Novo Nordisk Investigational Site Warszawa

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of severe hypoglycaemic episodes No
Secondary Number of severe hypoglycaemic episodes No
Secondary Number of mild hypoglycaemic episodes No
Secondary Postprandial glucose concentration after breakfast, lunch, and dinner No
Secondary Average fasting glucose concentration after waking and before main meals No
Secondary Average plasma glucose level at bedtime and at night No
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