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

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ClinicalTrials.gov Identifier: NCT00562172
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Insulin glargine Drug: Glimepiride Drug: Metformin Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2007
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: Insulin glargine
Once daily in the morning
Drug: Metformin
At least 1000 mg/day
Active Comparator: 2 Drug: Glimepiride
Once daily in the morning
Drug: Metformin
At least 1000 mg/day


Outcome Measures

Primary Outcome Measures :
  1. ß-cell Function parameter [ Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study ]
  2. Glucose Homeostasis and glycemic control status [ Time Frame: From the signature of the Informed Consent Form (ICF) up to the end of study ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562172


Locations
Korea, Republic of
Sanofi-aventis
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Ji Young Ahn Sanofi
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00562172     History of Changes
Other Study ID Numbers: LANTU_L_02193
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Insulin
Metformin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors