An Observational Study to Compare the Safety and Effectiveness of NovoMix® 30 and Levemir⢠for the Treatment of Diabetes
Information source: Novo Nordisk
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus
Intervention: biphasic insulin aspart 30 (Drug); insulin detemir (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Novo Nordisk Official(s) and/or principal investigator(s):
Love Taganas, BSc Pharm, Study Director, Affiliation: Novo Nordisk Pharmaceuticals (Philippines), Inc.
Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
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.
Clinical Details
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
Study design: Cohort, Prospective
Primary outcome: Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions.
Secondary outcome: HbA1cFBG (Fasting Blood Glucose) Average (mean) fasting plasma glucose level Number of minor (including nocturnal) hypoglycaemic events Number of major (including nocturnal) hypoglycaemic events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com
Manila 1605, Philippines; Recruiting
Additional Information
Clinical Trials at Novo Nordisk
Starting date: November 2008
Ending date: May 2009
Last updated: January 30, 2009
|
