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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00046462
First received: September 30, 2002
Last updated: January 10, 2011
Last verified: January 2011
  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 3

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:


Further study details as provided by Sanofi:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Doug Green Sanofi
  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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
2,4-thiazolidinedione
Glargine
Insulin
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014