Type 2 Diabetes Mellitus
Conditions
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
Interventions
DRUGinsulin glargine
DRUGrosiglitazone
DRUGmetformin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Mean change from baseline in fasting insulin/C-peptide levels | — |
| Health-related quality of life was compared between the baseline visit and the follow-up assessments | — |
| Mean change from baseline for bodyweight. | — |
| Mean change from baseline in lipid levels (total cholesterol, HDL, LDL, TG, free fatty acids) | — |
| Secondary efficacy parameters were: a mean change from baseline in FPG | — |
Countries
United States
Outcome results
None listed