Status:
COMPLETED
Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
To compare the glycemic control, as measured by HbA1C, between insulin glargine and rosiglitazone add-on therapies in patients who fail oral combination of a sulfonylurea and metformin
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Diagnosis of type 2 diabetes mellitus for at least one year;
- Continuous treatment with at least half maximally labeled dose of a sulfonylurea and at least 1000 mg metformin daily for at least three months ;
- Glycated hemoglobin between 7.5 and 11 % units, inclusive;
- Willingness to accept, and ability to inject insulin glargine therapy
- EXCLUSION CRITERIA:
- Stroke, MI, coronary artery bypass graft, percutaneous transluminal coronary angioplasty or angina pectoris within the last 12 months;
- Congestive heart failure requiring pharmacological treatment;
- Serum creatinine \> 1.5 mg/dl for males, or \> 1.4 mg/dl for females;
- Acute or chronic metabolic acidosis, including diabetic ketoacidosis;
- Planned radiological examinations requiring administration of contrasting agents;
- Clinical evidence of active liver disease, or serum ALT 2.5 times the upper limit of the normal range;
- History of hypoglycemia unawareness;
- Pregnancy or lactation;
- Failure to use adequate contraception (women of current reproductive potential only);
- Known hypersensitivity to insulin glargine, rosiglitazone or any of the components of insulin glargine rosiglitazone;
- BMI \>25 kg/m2;
- Malignancy except basal cell carcinoma within the last five years;
- History of substance or alcohol abuse within last two years, or current addiction to substance or alcohol abuse;
- Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with completion of the study;
- Incapability to comply with study procedures
Exclusion
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
June 1 2002
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00358124
Start Date
January 1 2001
End Date
June 1 2002
Last Update
January 11 2011
Active Locations (1)
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1
Sanofi-Aventis
Bridgewater, New Jersey, United States, 08807