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

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00789711

Purpose

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.

Condition	Intervention
Diabetes Mellitus	Drug: biphasic insulin aspart 30 Drug: insulin detemir

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart Insulin Detemir

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Number of all (Major/Minor/Nocturnal) hypoglycaemic events, reported as serious adverse drug reactions. [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

HbA1c [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
FBG (Fasting Blood Glucose) [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Average (mean) fasting plasma glucose level [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]
Number of minor (including nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]
Number of major (including nocturnal) hypoglycaemic events [ Time Frame: during 12 months of treatment ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	6000
Study Start Date:	November 2008
Estimated Study Completion Date:	May 2009
Estimated Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	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
B	Drug: 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Any subject with diabetes mellitus who needs insulin treatment at the time of inclusion is eligible for the study, including newly diagnosed subjects who have never received insulin or an insulin analogue before

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789711

Contacts

Contact: Public Access to Clinical Trials - Novo Nordisk

Please Contact NN via email

clinicaltrials@novonordisk.com

Locations

Philippines

Manila, Philippines, 1605

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Love Taganas, BSc Pharm

Novo Nordisk Pharmaceuticals (Philippines), Inc.

More Information

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-3682
Study First Received:	November 10, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00789711
Health Authority:	Philippines: Bureau of Food and Drugs

Study placed in the following topic categories:

Metabolic Diseases
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009