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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046462
• Other study ID #: HOE901_4022
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2002
• Last updated: January 10, 2011
• Start date: November 2001
• Est. completion date: December 2004

Study information

• Verified date: January 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: December 2004
• Est. primary completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Drug:
• Lantus (insulin glargine [rDNA origin] injection)

• Metformin

• Glyburide

• Thiazolidinedione

Locations

Country	Name	City	State
United States	Aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		During the Study Conduct	No
Secondary	Occurrence of hypoglycemia		During the study conduct	No
Secondary	Change in fasting plasma glucose		During the study conduct	No
Secondary	Percentage of patients achieving HbA1C less than or equal to 7%		During the study conduct	No
Secondary	Time to glycemic control		During the study conduct	No
Secondary	Change in body weight		During the study conduct	No
Secondary	Change in serum lipid profile		During the study conduct	No