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

Completed

• Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: insulin detemir; Drug: biphasic insulin aspart 30

• Registration Number: NCT00789711
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-10
• Study First Submitted QC: 2008-11-12
• Study First Posted: 2008-11-13
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-27
• Last Update Posted: 2016-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3131

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
B	insulin detemir	-
A	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.	during 12 months of treatment

Secondary Outcome Measures

Name	Time	Method
HbA1c	at the end of the study
FBG (Fasting Blood Glucose)	at the end of the study
Number of minor (including nocturnal) hypoglycaemic events	during 12 months of treatment
Average (mean) fasting plasma glucose level	at the end of the study
Number of major (including nocturnal) hypoglycaemic events	during 12 months of treatment

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇵🇭 Manilla, Philippines