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

Sanofi

Status and phase

Completed

Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: rosiglitazone

Drug: insulin glargine

Drug: metformin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00358124

HOE901_4014

Details and patient eligibility

About

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

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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