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

Novo Nordisk A/S0 sites161 target enrollmentOctober 2007

ConditionsDiabetes Diabetes Mellitus, Type 2

Interventionsbiphasic insulin aspart

Drugsbiphasic insulin aspart

Overview

Phase: Phase 4
Intervention: biphasic insulin aspart
Conditions: Diabetes
Sponsor: Novo Nordisk A/S
Enrollment: 161
Primary Endpoint: Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

January 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novo Nordisk A/S

Responsible Party

Sponsor

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 oral anti-diabetic drugs (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

Arms & Interventions

BIAsp 30

Biphasic insulin aspart 30 administered once daily for 16 weeks. If HbA1c is higher than 7.0 % after 16 weeks of treatment, dose is increased to twice daily for another 16 weeks. If HbA1c is higher than 7.0 % after 32 weeks of treatment, dose is increased to three times daily until week 48 (end of trial).

Intervention: biphasic insulin aspart

Outcomes

Primary Outcomes

Percentage of Subjects Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%

Time Frame: week 48

Secondary Outcomes

Number of Hypoglycaemic Episodes(weeks 0-48)
Percentage of Trial Completers Achieving the Treatment Target of Glycosylated Haemoglobin (HbA1c) Below 7.0%(week 48)
Number of Diurnal Hypoglycaemic Episodes(weeks 0-48)
Number of Nocturnal Hypoglycaemic Episodes(weeks 0-48)
Number of Treatment Emergent Serious Adverse Events (SAEs)(weeks 0-48)