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Determine whether glycemic control is different between Lantus & a 3rd oral agent when failure with other treatment - Article


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Glyburide

Diabeta; Glynase; Micronase


Clinical Trial: Determine whether glycemic control is different between Lantus & a 3rd oral agent when failure with other treatment

This study is currently recruiting patients.

Sponsored by: Aventis Pharmaceuticals
Information provided by: Aventis Pharmaceuticals

Purpose

The purposes of the study is to determine whether blood sugar control is different between Lantus and a third oral anti-diabetic agent when added to patients who fail a thiazolidinedione and sulfonylurea or metformin combination.

Condition Treatment or Intervention Phase
Diabetes Mellitus
 Drug: Lantus (insulin glargine [rDNA origin] injection)
 Drug: Metformin
 Drug: Glyburide
 Drug: Thiazolidinedione
Phase IV

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Substituting Lantus®(insulin glargine[rDNAorigin]inj) for a thiazolidinedione vs. a 3rd oral agent as add-on therapy in patients failing a thiazolidinedione & sulfonylurea or Metformin Combination

Further Study Details: 

Expected Total Enrollment:  240

Study start: November 2001

Eligibility

Ages Eligible for Study:  18 Years   -   79 Years,  Genders Eligible for Study:  Both

Criteria

Key Inclusion:

  • Patients between 18 - 79 years of age with diagnosed type 2 diabetes for at least a year treated with stable doses of two oral antidiabetic drugs of which one is either Avandia or Actos for at least three months.

Key Exclusion:


Location and Contact Information

Shelly Sohne      (908) 243-6377    shelly.sohne@aventis.com

New Jersey
      Aventis, Bridgewater,  New Jersey,  08807,  United States; Recruiting

More Information

Study ID Numbers:  HOE901/4022
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  September 30, 2002
ClinicalTrials.gov Identifier:  NCT00046462
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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September 6, 2008



Page Updated: October 3, 2005
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