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

Type 2 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00562172
• Other study ID #: LANTU_L_02193
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2007
• Last updated: July 16, 2012
• Start date: September 2007
• Est. completion date: October 2010

Study information

• Verified date: July 2012
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board of Severance Hospital
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Insulin glargine
Once daily in the morning
• Glimepiride
Once daily in the morning
• Metformin
At least 1000 mg/day

Locations

Country	Name	City	State
Korea, Republic of	Sanofi-aventis	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ß-cell Function parameter		From the signature of the Informed Consent Form (ICF) up to the end of study	No
Primary	Glucose Homeostasis and glycemic control status		From the signature of the Informed Consent Form (ICF) up to the end of study	No
Secondary	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	No