Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes Mellitus
Intervention: Insulin glargine (Drug); Glimepiride (Drug); Metformin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Ji Young Ahn, Study Director, Affiliation: Sanofi-Aventis
Overall contact:
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
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
Clinical Details
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.
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: ß-cell Function parameterGlucose Homeostasis and glycemic control status
Secondary outcome: Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Public Registry GMA, Email: publicregistryGMA@sanofi-aventis.com
Sanofi-aventis, Seoul, Korea, Republic of; Recruiting
Additional Information
Starting date: October 2007
Last updated: January 9, 2009
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