NCT00562172
Completed
Phase 4
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.
ConditionsType 2 Diabetes Mellitus
Overview
- Phase
- Phase 4
- Intervention
- Metformin
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Sanofi
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- ß-cell Function parameter
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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
Investigators
Eligibility 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.
Arms & Interventions
1
Intervention: Metformin
2
Intervention: Glimepiride
1
Intervention: Insulin glargine
2
Intervention: Metformin
Outcomes
Primary Outcomes
ß-cell Function parameter
Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status
Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study
Secondary Outcomes
- Insulin resistance parameter, Hypoglycemic episode, symptomatic, Weight change, Lipid profile, Inflammatory markers (CRP, Adiponectin, etcs), Patient satisfaction with diabetes treatment, Urine analysis, Creatinine(End of the study)
Study Sites (1)
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