Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes - Tabular View

Tracking Information

First Received Date ^ICMJE

October 29, 2004

Last Updated Date

June 26, 2009

Start Date ^ICMJE

September 2004

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HbA1c [ Time Frame: after 1 year trial period ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

HbA1c after 1 year trial period

Change History

Complete list of historical versions of study NCT00095082 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Adverse events [ Designated as safety issue: Yes ]
Body weight [ Designated as safety issue: No ]
Hypoglycemia [ Designated as safety issue: Yes ]
Blood glucose [ Designated as safety issue: No ]
Insulin Treatment Satisfaction [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Adverse events
Body weight
Hypoglycemia
Blood glucose
Insulin Treatment Satisfaction

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes

Official Title ^ICMJE

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

Drug: insulin detemir
Drug: insulin glargine
Drug: insulin aspart

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

447

Completion Date

December 2005

Primary Completion Date

December 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Finland, France, Germany, Netherlands, Sweden

Administrative Information

NCT ID ^ICMJE

NCT00095082

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Study ID Numbers ^ICMJE

NN304-1430, EudraCT No: 2004-000086-35

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Per Clauson, MD, PhD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP