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

Study Overview
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Brief Summary
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: insulin glargine
* Drug: rosiglitazone
* Drug: metformin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin glargine|nan|
|Drug: rosiglitazone|nan|
|Drug: metformin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable was the change in HbA1C from baseline to the end of therapy. |  |  | 
| Other efficacy variables were the change from baseline in FPG, serum lipids and weight. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary efficacy parameters were: a mean change from baseline in FPG |  |  | 
| Mean change from baseline in fasting insulin/C-peptide levels |  |  | 
| Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids) |  |  | 
| Mean change from baseline for bodyweight. |  |  | 
| Health-related quality of life was compared between the baseline visit and the follow-up assessments |  |  |