Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study) - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00562172

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	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: Insulin glargine Drug: Glimepiride Drug: Metformin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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.

Resource links provided by NLM:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Glimepiride Insulin glargine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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 ]

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 ]

Estimated Enrollment:	74
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Insulin glargine Once daily in the morning Drug: Metformin At least 1000 mg/day
2: Active Comparator	Drug: Glimepiride Once daily in the morning Drug: Metformin At least 1000 mg/day

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562172

Locations

Korea, Republic of
Sanofi-aventis
Seoul, Korea, Republic of

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Ji Young Ahn

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	LANTU_L_02193
Study First Received:	November 15, 2007
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00562172 History of Changes
Health Authority:	Korea: Institutional Review Board of Severance Hospital

Additional relevant MeSH terms:

Metabolic Diseases
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents
Insulin

Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glargine
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010