Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study) | RxWiki

Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)

Overview[ - collapse ][ - ]

Purpose	Primary objective: To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients Secondary objective: To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Insulin glargine Drug: Glimepiride Drug: Metformin
Phase	Phase 4
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00562172
First Received	November 15, 2007
Last Updated	July 16, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	November 15, 2007
Last Updated Date	July 16, 2012
Start Date	September 2007
Estimated Primary Completion Date	October 2010
Current Primary Outcome Measures	ß-cell Function parameter [Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study] [Designated as safety issue: No] Glucose Homeostasis and glycemic control status [Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study] [Designated as safety issue: No]
Current Secondary Outcome Measures	Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine [Time Frame: End of the study] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
Official Title	Lantus vs Sulfonylurea as add-on Therapy in Type 2 Diabetic Patients Failing Metformin Monotherapy: Comparison of Effects on Beta Cell Function and Metabolic Profile.
Brief Summary	Primary objective: To compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early Type 2 Diabetes Mellitus patients Secondary objective: To assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Insulin glargine Once daily in the morning Drug: Glimepiride Once daily in the morning Drug: Metformin At least 1000 mg/day
Study Arm (s)	Experimental: 1 Active Comparator: 2

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	75
Estimated Completion Date	October 2010
Estimated Primary Completion Date	October 2010
Eligibility Criteria	List of Inclusion and Exclusion Criteria: Inclusion Criteria: - Type 2 Diabetes Mellitus patients on metformin monotherapy - 7% ≤ HbA1c ≤ 12% - 20 kg/m² ≤BMI ≤ 35 kg/m² - Diabetes duration: at least 6 months Exclusion Criteria: - Type 1 Diabetes Mellitus patients - Clinical evidence of active liver disease, or serum Alanine AminoTransferase 3 times the upper limit of the normal range - Serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females - Acute and chronic metabolic acidosis, including diabetic ketoacidosis - History of alcohol or other substance abuse - Pregnancy or not using contraceptive in childbearing aged women - Known hypersensitivity to Lantus, SU or metformin - Any disease or condition that in the opinion of the investigator may interfere with completion of the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Korea, Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT00562172
Other Study ID Numbers	LANTU_L_02193
Has Data Monitoring Committee	No
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Ji Young Ahn Sanofi
Verification Date	July 2012

Locations[ + expand ][ + ]