Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595374
• Other study ID #: NN304-1582
• Status: Completed
• Phase: Phase 3
• First received: January 7, 2008
• Last updated: February 22, 2017
• Start date: December 2, 2003
• Est. completion date: October 7, 2004

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 7, 2004
• Est. primary completion date: October 7, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin detemir

• insulin NPH

• insulin aspart

Locations

Country	Name	City	State
Netherlands	Novo Nordisk Investigational Site	Amersfoort
Netherlands	Novo Nordisk Investigational Site	Apeldoorn
Netherlands	Novo Nordisk Investigational Site	Den Haag
Netherlands	Novo Nordisk Investigational Site	Den Haag
Netherlands	Novo Nordisk Investigational Site	Den Helder
Netherlands	Novo Nordisk Investigational Site	Deventer
Netherlands	Novo Nordisk Investigational Site	Enschede
Netherlands	Novo Nordisk Investigational Site	Gouda
Netherlands	Novo Nordisk Investigational Site	Hoogeveen
Netherlands	Novo Nordisk Investigational Site	Leidschendam
Netherlands	Novo Nordisk Investigational Site	Meppel
Netherlands	Novo Nordisk Investigational Site	Rotterdam
Netherlands	Novo Nordisk Investigational Site	Stadskanaal
Netherlands	Novo Nordisk Investigational Site	Utrecht
Netherlands	Novo Nordisk Investigational Site	Waalwijk
Netherlands	Novo Nordisk Investigational Site	Weert
Netherlands	Novo Nordisk Investigational Site	Zevenaar
Netherlands	Novo Nordisk Investigational Site	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 26 weeks of treatment
Secondary	Plasma glucose profiles
Secondary	Change in body weight
Secondary	Quality of Life
Secondary	Incidence of adverse events
Secondary	Incidence of hypoglycaemic episodes

External Links

•   Clinical Trials at Novo Nordisk