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
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

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 April 17, 2014