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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Drug: Metformin; Drug: Lantus (insulin glargine [rDNA origin] injection); Drug: Glyburide; Drug: Thiazolidinedione

• Study Type: Interventional
• Enrollment: 240
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of hypoglycemia	During the study conduct
Change in fasting plasma glucose	During the study conduct
Percentage of patients achieving HbA1C less than or equal to 7%	During the study conduct
Time to glycemic control	During the study conduct
Change in body weight	During the study conduct
Change in serum lipid profile	During the study conduct

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Doug Green, Sanofi

Publications and helpful links

General Publications

• Hollander P, Sugimoto D, Vlajnic A, Kilo C. Combination therapy with insulin glargine plus metformin but not insulin glargine plus sulfonylurea provides similar glycemic control to triple oral combination therapy in patients with type 2 diabetes uncontrolled with dual oral agent therapy. J Diabetes Complications. 2015 Nov-Dec;29(8):1266-71. doi: 10.1016/j.jdiacomp.2015.05.022. Epub 2015 Jun 5.

Study record dates

Study Major Dates

• Study Start: November 1, 2001
• Primary Completion (Actual): November 1, 2004
• Study Completion (Actual): December 1, 2004

Study Registration Dates

• First Submitted: September 30, 2002
• First Submitted That Met QC Criteria: October 1, 2002
• First Posted (Estimate): October 2, 2002

Study Record Updates

• Last Update Posted (Estimate): January 11, 2011
• Last Update Submitted That Met QC Criteria: January 10, 2011
• Last Verified: January 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Metformin; Insulin Glargine; Glyburide; 2,4-thiazolidinedione
• Other Study ID Numbers: HOE901_4022