Insulin Glargine (Lantus) vs Sulfonylurea (SU) for BETA Cell Function (BETA Study)
NCT ID: NCT00562172
Last Updated: 2012-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2007-09-30
2010-10-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Insulin glargine
Once daily in the morning
Metformin
At least 1000 mg/day
2
Glimepiride
Once daily in the morning
Metformin
At least 1000 mg/day
Interventions
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Insulin glargine
Once daily in the morning
Glimepiride
Once daily in the morning
Metformin
At least 1000 mg/day
Eligibility Criteria
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Inclusion Criteria
* 7% ≤ HbA1c ≤ 12%
* 20 kg/m² ≤BMI ≤ 35 kg/m²
* Diabetes duration: at least 6 months
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Ji Young Ahn
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-aventis
Seoul, , South Korea
Countries
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References
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Moon JS, Ha KS, Yoon JS, Lee HW, Lee HC, Won KC; BETA study group. The effect of glargine versus glimepiride on pancreatic beta-cell function in patients with type 2 diabetes uncontrolled on metformin monotherapy: open-label, randomized, controlled study. Acta Diabetol. 2014 Apr;51(2):277-85. doi: 10.1007/s00592-013-0553-z. Epub 2014 Jan 21.
Other Identifiers
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LANTU_L_02193
Identifier Type: -
Identifier Source: org_study_id