Clinical trial NCT00595374: Efficacy and Safety of Insulin Detemir in Type 1 Diabetes
Official title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: HbA1c
timeFrame: after 26 weeks of treatment
Secondary outcomes:
measure: Plasma glucose profiles
measure: Change in body weight
measure: Quality of Life
measure: Incidence of adverse events
measure: Incidence of hypoglycaemic episodes
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Haag
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Den Helder
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Deventer
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Enschede
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Gouda
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Hoogeveen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Leidschendam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Meppel
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Rotterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Stadskanaal
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Waalwijk
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Weert
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zevenaar
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zwolle
country: Netherlands
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: