Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Metformin; Rosiglitazone

Criteria

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