Brief Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the blood glucose achieved with insulin detemir as add-on to current oral antidiabetic drug (OAD) treatment in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

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

Enrollment

132

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Apr 2004

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

5 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

8 months study duration

Study Start

First participant enrolled

April 1, 2004

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed

3.1 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2008

Completed

12 days until next milestone

First Posted

Study publicly available on registry

January 14, 2008

Completed

Last Updated

January 27, 2017

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

January 2, 2008

Last Update Submit

January 26, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c
after 20 weeks of treatment

Secondary Outcomes (4)

Fasting plasma glucose (FPG)
Within-subject variation
Change in body weight
Incidence of adverse events

Interventions

insulin detemirDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Type 2 diabetes for at least 12 months since diagnosis
Insulin naive subjects
OAD treatment for at least 4 months with max. two OAD treatments
Body mass index below 30.0 kg/m2
HbA1c between 7.0-11.0%

You may not qualify if:

OAD treatment with three or more OADs
Secondary diabetes
Known hypoglycaemia unawareness or recurrent major hypoglycaemia as judged by the Investigator
Uncontrolled hypertension
Known or suspected allergy to trial product or related products

Contact the study team to confirm eligibility.