Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

November 17, 2004

Last Updated Date

March 13, 2009

Start Date ^†

September 2004

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00097084 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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 ^†

Body Weight
Blood Glucose
Hypoglycemia
Adverse Events
Insulin Treatment Satisfaction

Descriptive Information

Brief Title ^†

Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes

Official Title ^†

Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart Versus Insulin Glargine Plus Insulin Aspart in Type 2 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 2 diabetes.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Diabetes Mellitus, Type 2

Intervention ^†

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 ^†

Completed

Estimated Enrollment ^†

300

Completion Date

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Type 2 diabetes for at least 12 months
Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs
BMI of maximum 40 kg/m2
HbA1c greater than or equal to 7.0% and 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 ^††

Location Countries ^†

United States, Finland, France, Norway, Sweden

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00097084

Responsible Party

Public Access to Clinical Trials, Novo Nordisk A/S

Secondary IDs ^††

EudraCT No: 2004-000087-27

Study Sponsor ^†

Novo Nordisk

Collaborators ^††

Investigators ^†

Study Director:

Per Clauson, MD, PhD

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

March 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.