An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir™ for the Treatment of Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— SAFE  

Official title:

A Multicentre, Open-label, Nonrandomised, Non-interventional, Observational Study to Compare Safety and Effectiveness of Biphasic Insulin Aspart 30 (NovoMix 30) and Insulin Detemir (Levemir) for the Treatment of Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789711
• Other study ID #: BIASP-3682
• Status: Completed
• Phase: N/A
• First received: November 10, 2008
• Last updated: October 27, 2016
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2016
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Philippines: Bureau of Food and Drugs
• Study type: Observational

Clinical Trial Summary

This study is conducted in Asia. The aim of this observational study is to compare the clinical safety profile and effectiveness of NovoMix® 30 and Levemir™ for the treatment of diabetes in the Philippines.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3131
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with type 1 or type 2 diabetes mellitus

• Patients uncontrolled on oral antidiabetic drugs

• Insulin naïve patients or patients currently on human insulin

Exclusion Criteria:

• Subjects who are unlikely to comply with protocol requirements

• Subjects who are previously enrolled in NovoMix® 30 and Levemir™ study

• Subjects on NovoMix® 30 and Levemir™ therapy

• Subjects with hypersensitivity to NovoMix® 30 or to any of the excipients

• Subjects with hypersensitivity to Levemir™ or to any of the excipients

• Females of child bearing potential who are pregnant, breast feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures are required by local law or practice

• Contraindications and warnings specified in the current prescribing information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Evaluation of the safety profile and effectiveness of biphasic insulin aspart 30 in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines
• insulin detemir
Evaluation of the safety profile and effectiveness of insulin detemir in the treatment of diabetes mellitus under normal clinical practice conditions in the Philippines

Locations

Country	Name	City	State
Philippines	Novo Nordisk Investigational Site	Manilla

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.		during 12 months of treatment	Yes
Secondary	HbA1c		at the end of the study	No
Secondary	FBG (Fasting Blood Glucose)		at the end of the study	No
Secondary	Average (mean) fasting plasma glucose level		at the end of the study	No
Secondary	Number of minor (including nocturnal) hypoglycaemic events		during 12 months of treatment	Yes
Secondary	Number of major (including nocturnal) hypoglycaemic events		during 12 months of treatment	Yes

External Links

•   Clinical Trials at Novo Nordisk