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

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00046462

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	Intervention	Phase
Diabetes Mellitus	Drug: Lantus (insulin glargine [rDNA origin] injection) Drug: Metformin Drug: Glyburide Drug: Thiazolidinedione	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Medicines

Drug Information available for: Glyburide Insulin Insulin beef Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Occurrence of hypoglycemia [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Change in fasting plasma glucose [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Percentage of patients achieving HbA1C less than or equal to 7% [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Time to glycemic control [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Change in body weight [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Change in serum lipid profile [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]

Estimated Enrollment:	240
Study Start Date:	November 2001
Study Completion Date:	December 2004
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 79 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046462

Locations

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

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Doug Green

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00046462 History of Changes
Other Study ID Numbers:	HOE901_4022
Study First Received:	September 30, 2002
Last Updated:	January 10, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
2,4-thiazolidinedione
Glargine
Glyburide

Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012