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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 28, 2007

Last Updated Date

February 11, 2009

Start Date ^†

October 2007

Current 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 ]

Original Primary Outcome Measures ^†

Percentage of subjects achieving HbA1c below 7.0% [ Time Frame: after 16, 32 and 48 weeks, respectively ]

Change History

Complete list of historical versions of study NCT00537277 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

Drug: biphasic insulin aspart

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

167

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Turkey

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00537277

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Secondary IDs ^††

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

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

Information Provided By

Novo Nordisk

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.