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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00562172
First received: November 15, 2007
Last updated: July 16, 2012
Last verified: July 2012
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

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 ]

Enrollment: 75
Study Start Date: September 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Director: Ji Young Ahn Sanofi
  More Information

No publications provided by Sanofi

Additional 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
Study First Received: November 15, 2007
Last Updated: July 16, 2012
Health Authority: Korea: Institutional Review Board of Severance Hospital

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

ClinicalTrials.gov processed this record on July 22, 2014