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
387 participants
INTERVENTIONAL
2006-06-30
Brief Summary
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* To investigate the efficacy of insulin glargine (in terms of change in A1c from baseline to endpoint A1c \< 7%)
Secondary:
* To investigate the safety of insulin glargine (in terms of hypoglycaemia, including symptomatic, non-symptomatic and nocturnal hypoglycaemia)
* To investigate whether beta cell function is preserved if this therapy is initiated before 2nd OAD (oral anti-diabetic drug) failure
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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
Administration of Insulin Glargine and Sulfonylurea or Metformin
Insulin Glargine
Throughout study period
Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
2
Administration of Sulfonylurea or Metformin + a second Oral Anti Diabetic (OAD) among Glyburide, Glyclazide,Glimiperide,Glipizide or Metformin
Glyburide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Glyclazide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Glimiperide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Glipizide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Interventions
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Insulin Glargine
Throughout study period
Glyburide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Glyclazide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Glimiperide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Glipizide
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Metformin
Combination throughout the study period. Titrate to FPG ≤ 100 mg/dl.
Eligibility Criteria
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Inclusion Criteria
* Patients who are insulin naive (unless it was used for gestational diabetes or if insulin therapy was less than 1 week)
* Serum creatinine ≤ 1.5mg/dL
* BMI: 21-41 kg/m²
* 7.5%\< A1c \<11%
* Fasting plasma glucose \> 7.5mmol/L
* On diet and exercise therapy and stable OAD treatment (SU or metformin \> ½ maximal dose)for more than 1 month prior to enrolment
* Women not of childbearing potential (sterilization procedure done or menopausal \> 2 years), or if of childbearing potential, agree to take reliable contraceptive measures during the study
* Able and willing to monitor blood glucose
* Able and willing to perform 7 point blood glucose self monitoring at baseline, 12 week and 24 week
* Understand that there is a 50% chance of being randomized to the insulin treatment arm and is willing to self inject insulin
Exclusion Criteria
* Acute complication of diabetes, such as diabetic ketoacidosis and hyperosmolar coma
* Pregnancy, breast-feeding
* People who work night shifts
* Hypersensitivity to investigational drugs or its additives, or intolerability to metformin
* Need for use of medications prohibited by the protocol during the study for treatment purpose
* Significant diseases in cardiovascular, liver, nerve, endocrine or other systems, unable to complete the study or difficult to be used in study analysis
* Drugs or alcohol abuse
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
80 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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Bruno Jolain
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Beijing, , China
Countries
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Other Identifiers
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LANTU_L_01051
Identifier Type: -
Identifier Source: org_study_id
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