Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00349986 |
Date of registration:
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07/07/2006 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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LANTUSTITR: Insulin Glargine in Type 2 Diabetes Mellitus
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Scientific title:
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The Determination of the First Dose and the Optimal Time of Administration of Insulin Glargine Combined With Oral Antidiabetic Drug in Poorly Controlled Type II Diabetic Patients |
Date of first enrolment:
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September 2006 |
Target sample size:
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4 |
Recruitment status: |
Terminated |
URL:
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http://clinicaltrials.gov/show/NCT00349986 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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Hungary
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Contacts
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Name:
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László Eros, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Sanofi |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Type 2 Diabetes Mellitus
- Insufficient combined oral antidiabetic treatment (biguanide + sulfonylurea)
- BMI >25 kg/m2 , <30 kg/m2
- HbA1c value >7.0%, <9.0% within one month
Exclusion Criteria:
- Type 1 Diabetes Mellitus
- Known malignancy
- Drug or alcohol abuse
- Severe liver disease
- Renal failure (se Creatinine > 150 micro mol/l)
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes Mellitus, Type 2
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Intervention(s)
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Drug: Insuline glargine
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Primary Outcome(s)
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HgbA1c measurement
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Secondary ID(s)
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HOE901_4059
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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