Brief Summary

This trial is conducted in Europe. The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

Trial Health

On Track

Trial Health Score

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

Enrollment

114

participants targeted

Target at below P25 for phase_3 diabetes

Timeline

Completed

Started Dec 2003

Shorter than P25 for phase_3 diabetes

Geographic Reach

1 country

18 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

10 months study duration

Study Start

First participant enrolled

December 2, 2003

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2004

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 7, 2004

Completed

3.3 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2008

Completed

9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2008

Completed

Last Updated

February 24, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

January 7, 2008

Last Update Submit

February 22, 2017

Conditions

Diabetes Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

HbA1c
after 26 weeks of treatment

Secondary Outcomes (5)

Plasma glucose profiles
Change in body weight
Quality of Life
Incidence of adverse events
Incidence of hypoglycaemic episodes

Interventions

insulin detemirDRUG

insulin NPHDRUG

insulin aspartDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Duration of type 1 diabetes for at least 12 months
BMI below 35 kg/m2
HbA1c between 7.0-12.0%
Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

You may not qualify if:

Known or suspected allergy to trial product or related products
Previous participation in this trial
Receipt of any investigational products within the last 2 months prior to this trial
Drug or alcohol dependence
Pregnancy, breast-feeding or intention of becoming pregnant

Contact the study team to confirm eligibility.