Efficacy and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes Mellitus When Failing on OADs - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00537277

Purpose

This trial is conducted in Europe. This is a clinical trial investigating the effectiveness and the safety of using Biphasic Insulin Aspart 30 both for initiation and intensification of insulin treatment in type 2 diabetes

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

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin aspart

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Titrate-To-Target Study of the Efficacy and Safety of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Mellitus Not Achieving Glycaemic Targets on OADs With / Without Once Daily Basal Insulin Therapy

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: after 16, 32 and 48 weeks, respectively ] [ Designated as safety issue: No ]
Number of all major hypoglycaemic events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Percentage of subjects achieving HbA1c levels below 7.0% at different treatments [ Time Frame: after 16, 32 and 48 weeks, respectively ] [ Designated as safety issue: No ]
Number of serious adverse events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]
Number of all minor hypoglycaemic events [ Time Frame: during treatment ] [ Designated as safety issue: Yes ]

Enrollment:	167
Study Start Date:	October 2007
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Drug: biphasic insulin aspart Treat-to-target dose titration scheme

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 2 Diabetes Mellitus for more than 12 months
HbA1c: 7.5 - 11.0%
An antidiabetic regimen that has been stable for at least 3 months prior to screening
An antidiabetic regimen that includes a minimum of 2 OADs or 1 OAD plus evening or bedtime basal insulin
OADs dosed at 50% or more of the maximum recommended dose

Exclusion Criteria:

Use of any insulin preparations other than NPH or glargine within the past 6 months
Use of more than 60 units of insulin per day
Morning time insulin administration
Use of more than one insulin dose daily

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537277

Locations

Turkey

ISTANBUL, Turkey

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:	Asude Arslan, BSc	Novo Nordisk Turkey
Study Director:	Suzan Dumanli, MD	Novo Nordisk Turkey

More Information

Additional Information:

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

No publications provided

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	BIASP-1849
Study First Received:	September 28, 2007
Last Updated:	February 11, 2009
ClinicalTrials.gov Identifier:	NCT00537277 History of Changes
Health Authority:	Turkey: Ministry of Health Drug and Pharmaceutical Department

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Diabetes Mellitus, Type 2
Insulin, Asp(B28)-

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 06, 2009