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
1 other identifier
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus
Started Nov 2001
Typical duration for phase_3 diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 30, 2002
CompletedFirst Posted
Study publicly available on registry
October 2, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedJanuary 11, 2011
January 1, 2011
3 years
September 30, 2002
January 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
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
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major cardiovascular events
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Aventis
Bridgewater, New Jersey, 08807, United States
Related Publications (1)
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.
PMID: 26281972DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Doug Green
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 30, 2002
First Posted
October 2, 2002
Study Start
November 1, 2001
Primary Completion
November 1, 2004
Study Completion
December 1, 2004
Last Updated
January 11, 2011
Record last verified: 2011-01