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Determine Whether Glycemic Control is Different Between Lantus & a 3rd Oral Agent When Failure With Other Treatment

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ClinicalTrials.gov Identifier: NCT00046462
Recruitment Status : Completed
First Posted : October 2, 2002
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Sanofi

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Metformin Drug: Glyburide Drug: Thiazolidinedione Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : November 2001
Actual Primary Completion Date : November 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy [ Time Frame: During the Study Conduct ]

Secondary Outcome Measures :
  1. Occurrence of hypoglycemia [ Time Frame: During the study conduct ]
  2. Change in fasting plasma glucose [ Time Frame: During the study conduct ]
  3. Percentage of patients achieving HbA1C less than or equal to 7% [ Time Frame: During the study conduct ]
  4. Time to glycemic control [ Time Frame: During the study conduct ]
  5. Change in body weight [ Time Frame: During the study conduct ]
  6. Change in serum lipid profile [ Time Frame: During the study conduct ]


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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Major cardiovascular events

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00046462


Locations
United States, New Jersey
Aventis
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Doug Green Sanofi

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00046462     History of Changes
Other Study ID Numbers: HOE901_4022
First Posted: October 2, 2002    Key Record Dates
Last Update Posted: January 11, 2011
Last Verified: January 2011

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2,4-thiazolidinedione
Insulin
Metformin
Insulin Glargine
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs