Observational Study to Observe the Safety of NovoMix® 30 Treatment in Patients With Type 2 Diabetes - Full Text View

Purpose

This study is conducted in Europe.

The study aims to observe the incidence of serious adverse drug reactions in patients with type 2 diabetes during NovoMix® 30 treatment.

Condition	Intervention
Diabetes Mellitus, Type 2	Drug: biphasic insulin aspart 30

MedlinePlus related topics:

Diabetes

ChemIDplus related topics:

Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Safety of NovoMix® 30 (Biphasic Insulin Aspart) Treatment in Patients With Type 2 Diabetes

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Incidence of serious adverse drug reactions, including major hypoglycaemic events [ Time Frame: after 12 and 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Number of all hypoglycaemic events [ Time Frame: in the 4 weeks preceding visit, at 12 weeks and the final visit at 26 weeks ] [ Designated as safety issue: No ]
Number of all adverse drug reactions [ Time Frame: after 12 and 26 weeks ] [ Designated as safety issue: Yes ]
HbA1c [ Time Frame: at 12 and 26 weeks ] [ Designated as safety issue: No ]
Variability in fasting plasma glucose (FPG) values and average FPG levels [ Time Frame: at visits at 12 and 26 weeks ] [ Designated as safety issue: No ]
Weight changes [ Time Frame: at visits at 12 and 26 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1800
Study Start Date:	February 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
A	Drug: biphasic insulin aspart 30 Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Study population type 2 diabetes strated on NovoMix® 30

Criteria

Inclusion Criteria:

Any patient with diabetes type 2 diabetes
Currently treated with basal human insulin therapy (basal only or in combination with oral glucose lowering drugs or other insulin
Selection of patients will be at the discretion of the treating physician after the decision to prescribe one of the study products to the patient

Exclusion Criteria:

Known or suspected allergy to study product(s) or related products
Pregnancy, breast-feeding or intention of becoming pregnant within the next 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729898

Contacts


Contact: Public Access to Clinical Trials - Novo Nordisk	Please Contact NN via email	clinicaltrials@novonordisk.com

Locations


Denmark
		Recruiting
	Copenhagen S, Denmark, 2300

Norway
		Recruiting
	Rud, Norway, 1309

Sweden
		Recruiting
	FARSTA, Sweden, 123 47

Sponsors and Collaborators

Novo Nordisk

Investigators


Study Director:	Michael Ländin, PM	Novo Nordisk Scandinavia AB

Study Director:	Jakob Larsen	Novo Nordisk Scandinavia AB

Study Director:	Erik Christiansen, medical manager	Novo Nordisk Scandinavia AB

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-3512
First Received:	August 5, 2008
Last Updated:	August 5, 2008
ClinicalTrials.gov Identifier:	NCT00729898
Health Authority:	Denmark: Danish Medicines Agency; Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus, Type 2

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 September 22, 2008

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00729898