Insulin Glargine [rDNA Origin] Injection vs Pioglitazone as add-on Therapy in Patients Failing Monotherapy With Sulfonylurea or Metformin
Phase 4
Completed
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- NCT00384215
- Lead Sponsor
- Sanofi
- Brief Summary
This trial will explore the various advantages and possible disadvantages of pioglitazone and insulin glargine when added to monotherapy. Glycemic control, hypoglycemia, weight, lipid profiles, quality of life and cost will be studied given a comprehensive set of data that may help future treatment decisions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To determine whether glycemic control as measured by HbA1c is different between insulin glargine [rDNA Origin] injection and pioglitazone when added to subjects who fail monotherapy with SU or metformin.
- Secondary Outcome Measures
Name Time Method Compare occurrence of hypoglycemia Compare change in body weight Compare change in FPG Compare change in serum lipid profile Compare percentage of subjects achieving HbA1c levels </= 7% Compare the time until an HbA1c </= 7% is achieved Compare change in HRQOL Compare cost of therapy for hyperglycemia treatment
Trial Locations
- Locations (1)
Sanofi-Aventis
🇺🇸Bridgewater, New Jersey, United States