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

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

Overview[ - collapse ][ - ]

Purpose	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
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: insulin glargine Drug: rosiglitazone Drug: metformin
Phase	Phase 4
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00358124
First Received	July 28, 2006
Last Updated	January 10, 2011
Last verified	January 2011

Tracking Information[ + expand ][ + ]

First Received Date	July 28, 2006
Last Updated Date	January 10, 2011
Start Date	January 2001
Estimated Primary Completion Date	June 2002
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	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

Descriptive Information[ + expand ][ + ]

Brief Title	Insulin Glargine v Rosiglitazone as add-on Therapy in Patients Failing Sulfonylurea and Metformin Combination Therapy
Official Title	Not Provided
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: insulin glargine Drug: rosiglitazone Drug: metformin
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	220
Estimated Completion Date	June 2002
Estimated Primary Completion Date	Not Provided
Eligibility 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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00358124
Other Study ID Numbers	HOE901_4014
Has Data Monitoring Committee	Not Provided
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Karen Barch Sanofi
Verification Date	January 2011

Locations[ + expand ][ + ]