Clinical trial NCT00095082: Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes
Official title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type I
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2004-11-01
Enrollment: 447
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 and the United States of America (USA). The purpose of this study is to test whether insulin detemir is a safe and at least as effective alternative to insulin glargine for the control of blood glucose in basal/bolus therapy in patients with type I diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes for at least 12 months
* Current treatment with basal-bolus insulin regimen for more than or equal to 3 months
* HbA1c less than or equal to 11.0%

Exclusion Criteria:

* Proliferative retinopathy or maculopathy
* Recurrent major hypoglycaemia
* Impaired hepatic or renal function
* Cardiac problems or uncontrolled hypertension

Primary outcomes:
measure: HbA1c
timeFrame: after 1 year trial period
Secondary outcomes:
measure: Adverse events
measure: Body weight
measure: Hypoglycemia
measure: Blood glucose
measure: Insulin Treatment Satisfaction
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Huntington Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Inglewood
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Irvine
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: La Jolla
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Hollywood
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Lake Mary
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
city: Chicago
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Hyattsville
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Detroit
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: St. Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Berlin
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Sea Girt
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Asheville
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Dallas
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Helsinki
country: Finland
facility: Novo Nordisk Investigational Site
city: Kuopio
country: Finland
facility: Novo Nordisk Investigational Site
city: Oulu
country: Finland
facility: Novo Nordisk Investigational Site
city: Pori
country: Finland
facility: Novo Nordisk Investigational Site
city: Vantaa
country: Finland
facility: Novo Nordisk Investigational Site
city: ANGERS cedex 09
country: France
facility: Novo Nordisk Investigational Site
city: Antibes
country: France
facility: Novo Nordisk Investigational Site
city: Brest
country: France
facility: Novo Nordisk Investigational Site
city: GRENOBLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: LA ROCHELLE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Mougins
country: France
facility: Novo Nordisk Investigational Site
city: TOULOUSE cedex
country: France
facility: Novo Nordisk Investigational Site
city: Alsdorf
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Dormagen
country: Germany
facility: Novo Nordisk Investigational Site
city: Dresden
country: Germany
facility: Novo Nordisk Investigational Site
city: Flensburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Friedrichsthal
country: Germany
facility: Novo Nordisk Investigational Site
city: Genthin
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Herrenberg
country: Germany
facility: Novo Nordisk Investigational Site
city: Kippenheim
country: Germany
facility: Novo Nordisk Investigational Site
city: Rehlingen-Siersburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Speyer
country: Germany
facility: Novo Nordisk Investigational Site
city: St. Ingbert
country: Germany
facility: Novo Nordisk Investigational Site
city: Völklingen
country: Germany
facility: Novo Nordisk Investigational Site
city: Würzburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Almere
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Apeldoorn
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Capelle a/d IJssel
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Dordrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Leeuwarden
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Zoetermeer
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Norrköping
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Umeå
country: Sweden
facility: Novo Nordisk Investigational Site
city: Växjö
country: Sweden
facility: Novo Nordisk Investigational Site
city: Örebro
country: Sweden
facility: Novo Nordisk Investigational Site
city: Abergavenny
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Ayr
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Brighton
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Bristol
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Cosham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Dundee
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Glasgow
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Livingstone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Plymouth
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Watford
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wirral, Merseyside
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heller S, Koenen C, Bode B. Comparison of insulin detemir and insulin glargine in a basal-bolus regimen, with insulin aspart as the mealtime insulin, in patients with type 1 diabetes: a 52-week, multinational, randomized, open-label, parallel-group, treat-to-target noninferiority trial. Clin Ther. 2009 Oct;31(10):2086-97. doi: 10.1016/j.clinthera.2009.10.006.