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NCT01542060 Clinical Trial

Efficacy and Safety of Biphasic Insulin Aspart 30 for the Treatment of Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
A Clinical Experience Programme to Collect Data on the Safety and Efficacy of NovoMix® 30 in the Treatment of Patients With Type 2 Diabetes in Jordan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01542060
Other study ID # BIASP-1892
Secondary ID
Status Completed
Phase N/A
First received February 15, 2012
Last updated April 11, 2012
Start date January 2004
Est. completion date December 2004

Study information
Verified date April 2012
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority Jordan: Ministry of Health
Study type Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to collect efficacy and safety data of biphasic insulin aspart (NovoMix® 30) in type 2 diabetes under normal clinical practice conditions.

Recruitment information / eligibility
Status Completed
Enrollment 298
Est. completion date December 2004
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Subjects from hospitals or clinics, diagnosed with type 2 diabetes mellitus

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• biphasic insulin aspart 30
Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician

Locations
Country Name City State
n/a

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

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary HbA1c (glycosylated haemoglobin) No
Secondary FBG (Fasting Blood Glucose) No
Secondary Quality of life assessed through the WHO-DTSQ (World Health Organization-Diabetes Treatment Satisfaction Questionnaire) No
Secondary Incidence of adverse events No
Secondary Incidence of hypoglycaemic episodes No
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