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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Insulin glargine; Drug: Glimepiride; Drug: Metformin

• Registration Number: NCT00562172
• Lead Sponsor: Sanofi

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 available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-16
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Insulin glargine	-
1	Metformin	-
2	Glimepiride	-
2	Metformin	-

Primary Outcome Measures

Name	Time	Method
ß-cell Function parameter	From the signature of the Informed Consent Form (ICF) up to the end of study
Glucose Homeostasis and glycemic control status	From the signature of the Informed Consent Form (ICF) up to the end of study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sanofi-aventis; 🇰🇷 Seoul, Korea, Republic of