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Safety and Efficacy of Insulin Detemir plus Insulin Aspart vs. Insulin Glargine plus Insulin Aspart as Mealtime Insulin in Type I Diabetes - Article


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Insulin glargine

insulin glargine [rDNA origin]; Lantus


Clinical Trial: Safety and Efficacy of Insulin Detemir plus Insulin Aspart vs. Insulin Glargine plus Insulin Aspart as Mealtime Insulin in Type I Diabetes

This study is no longer recruiting patients.

Sponsored by: Novo Nordisk
Information provided by: Novo Nordisk

Purpose

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.

Condition Treatment or Intervention Phase
Diabetes Mellitus, Type I
 Drug: insulin detemir
 Drug: Lantus (insulin glargine)
 Drug: Novolog (insulin aspart)
Phase III

MedlinePlus related topics:  Juvenile Diabetes

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

Expected Total Enrollment:  435

Study start: October 2004;  Study completion: March 2006
Last follow-up: January 2006;  Data entry closure: February 2006

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Type I diabetics age 18 or older that have had diabetes for at least 12 months.

Location Information


California
      San Diego,  California,  92161,  United States

      Huntington Beach,  California,  92646,  United States

      San Francisco,  California,  94143,  United States

      Inglewood,  California,  90301,  United States

      Irvine,  California,  92618,  United States

      La Jolla,  California,  92037,  United States

      Anaheim,  California,  92801,  United States

Florida
      Melbourne,  Florida,  32901,  United States

      Vero Beach,  Florida,  32960,  United States

      Hollywood,  Florida,  33021,  United States

      Tampa,  Florida,  33613,  United States

      Winter Park,  Florida,  32789,  United States

Georgia
      Atlanta,  Georgia,  30309,  United States

Idaho
      Idaho Falls,  Idaho,  83404,  United States

Illinois
      Chicago,  Illinois,  60607,  United States

Kansas
      Topeka,  Kansas,  66606,  United States

Michigan
      Detroit,  Michigan,  48235,  United States

Missouri
      St. Louis,  Missouri,  63110,  United States

Nebraska
      Omaha,  Nebraska,  68131,  United States

Nevada
      Las Vegas,  Nevada,  89109,  United States

New Jersey
      Brick,  New Jersey,  08724,  United States

      Berlin,  New Jersey,  08009,  United States

North Carolina
      Asheville,  North Carolina,  28801,  United States

Pennsylvania
      Philadelphia,  Pennsylvania,  19107,  United States

Texas
      Dallas,  Texas,  75235,  United States

      Houston,  Texas,  77030,  United States

      Dallas,  Texas,  75390-8858,  United States

      San Antonio,  Texas,  78229,  United States

More Information

Study ID Numbers:  NN304-1430
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  October 29, 2004
ClinicalTrials.gov Identifier:  NCT00095082
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005


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October 12, 2008



Page Updated: September 6, 2005
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