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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus

Intervention: Lantus (insulin glargine [rDNA origin] injection) (Drug); Metformin (Drug); Glyburide (Drug); Thiazolidinedione (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Doug Green, Study Director, Affiliation: Sanofi


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.

Clinical Details

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

Primary outcome: 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

Secondary outcome:

Occurrence of hypoglycemia

Change in fasting plasma glucose

Percentage of patients achieving HbA1C less than or equal to 7%

Time to glycemic control

Change in body weight

Change in serum lipid profile


Minimum age: 18 Years. Maximum age: 79 Years. Gender(s): Both.


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.

Locations and Contacts

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

Starting date: November 2001
Last updated: January 10, 2011

Page last updated: August 23, 2015

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