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

NCT ID: NCT00097084

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2005-12-31

Brief Summary

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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

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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insulin detemir

Intervention Type DRUG

insulin glargine

Intervention Type DRUG

insulin aspart

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Little Rock, Arkansas, United States

Site Status

Novo Nordisk Investigational Site

Inglewood, California, United States

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Novo Nordisk Investigational Site

San Francisco, California, United States

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Novo Nordisk Investigational Site

Santa Ana, California, United States

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Spring Valley, California, United States

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Novo Nordisk Investigational Site

Boca Raton, Florida, United States

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Novo Nordisk Investigational Site

Jacksonville, Florida, United States

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Novo Nordisk Investigational Site

Lake Mary, Florida, United States

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Novo Nordisk Investigational Site

Melbourne, Florida, United States

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Orlando, Florida, United States

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Palm Harbor, Florida, United States

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Novo Nordisk Investigational Site

Vero Beach, Florida, United States

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Novo Nordisk Investigational Site

Athens, Georgia, United States

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Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

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Novo Nordisk Investigational Site

Topeka, Kansas, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Berlin, New Jersey, United States

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Asheville, North Carolina, United States

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Hermitage, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Newport News, Virginia, United States

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Richmond, Virginia, United States

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Novo Nordisk Investigational Site

Tacoma, Washington, United States

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Novo Nordisk Investigational Site

Espoo, , Finland

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Novo Nordisk Investigational Site

Helsinki, , Finland

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Novo Nordisk Investigational Site

Kurikka, , Finland

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Novo Nordisk Investigational Site

Lahti, , Finland

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Novo Nordisk Investigational Site

Lapua, , Finland

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Oulu, , Finland

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Novo Nordisk Investigational Site

Turku, , Finland

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Novo Nordisk Investigational Site

Brest, , France

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Le Mans, , France

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Montpellier, , France

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Nanterre, , France

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Narbonne, , France

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Novo Nordisk Investigational Site

Nevers, , France

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Novo Nordisk Investigational Site

Orléans, , France

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Novo Nordisk Investigational Site

Paris, , France

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Novo Nordisk Investigational Site

Vénissieux, , France

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Novo Nordisk Investigational Site

Bergen, , Norway

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Novo Nordisk Investigational Site

Notodden, , Norway

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Novo Nordisk Investigational Site

Sarpsborg, , Norway

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Novo Nordisk Investigational Site

Ski, , Norway

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Novo Nordisk Investigational Site

Stavanger, , Norway

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Novo Nordisk Investigational Site

Trondheim, , Norway

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Novo Nordisk Investigational Site

Ängelholm, , Sweden

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Novo Nordisk Investigational Site

Falun, , Sweden

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Novo Nordisk Investigational Site

Gothenburg, , Sweden

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Novo Nordisk Investigational Site

Kalmar, , Sweden

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Novo Nordisk Investigational Site

Lund, , Sweden

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Novo Nordisk Investigational Site

Lund, , Sweden

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Novo Nordisk Investigational Site

Malmo, , Sweden

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Novo Nordisk Investigational Site

Motala, , Sweden

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Novo Nordisk Investigational Site

Oskarshamn, , Sweden

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Novo Nordisk Investigational Site

Uddevalla, , Sweden

Site Status

Countries

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United States Finland France Norway Sweden

References

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Hollander P, Cooper J, Bregnhoj J, Pedersen CB. A 52-week, multinational, open-label, parallel-group, noninferiority, treat-to-target trial comparing insulin detemir with insulin glargine in a basal-bolus regimen with mealtime insulin aspart in patients with type 2 diabetes. Clin Ther. 2008 Nov;30(11):1976-87. doi: 10.1016/j.clinthera.2008.11.001.

Reference Type RESULT
PMID: 19108786 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2004-000087-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NN304-1431

Identifier Type: -

Identifier Source: org_study_id

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