Brief Summary

This trial is conducted in Europe. The aim of this trial is to investigate the efficacy and safety of an intensified treatment regimen with preprandial insulin aspart and insulin detemir once or twice daily to a more convenient regimen with biphasic insulin aspart 30 twice daily on blood glucose control in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

719

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Dec 2003

Geographic Reach

3 countries

127 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.3 years study duration

Study Start

First participant enrolled

December 2, 2003

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2005

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2005

Completed

2.9 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2008

Completed

13 days until next milestone

First Posted

Study publicly available on registry

January 30, 2008

Completed

Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

1.3 years

First QC Date

January 17, 2008

Last Update Submit

June 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c
after 6 months of treatment

Secondary Outcomes (5)

Incidence of hypoglycaemic episodes
Adverse events
Difference of HbA1c change between the two groups
after 13 weeks of treatment
Fasting plasma glucose of treatment
after 13 and 26 weeks
Change in weight

Interventions

insulin detemirDRUG

Also known as: Levemir

insulin aspartDRUG

biphasic insulin aspartDEVICE

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Type 2 diabetes
Duration of type 2 diabetes for at least 6 months since diagnosis
Current treatment with one or two oral antidiabetic drugs for at least 3 months or with one or two oral antidiabetic drugs, given for at least 3 months in combination with intermediate or long-acting insulin/insulin analogue once daily
BMI below 40 kg/m2
HbA1c between 7-12%
Able and willing to perform self-monitoring of capillary blood glucose

You may not qualify if:

Current antidiabetic treatment with combination of three or more oral antidiabetic drugs
Previous treatment with short-acting human insulin, short-acting insulin analogue or biphasic insulin/insulin analogue within the last 6 months (7 days or less within the last 6 months is allowed)
Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
Known or suspected allergy to trial product or related products
Pregnancy, breast-feeding, the intention of becoming pregnant or judged to be using inadequate contraceptive measures
Receipt of any investigational drug within 4 weeks prior to this trial
Previous participation in this trial

Contact the study team to confirm eligibility.