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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00701831 |
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Date of registration:
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18/06/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessment of Insulin Glargine in Type 2 Patients for Good Glycemic Control
LANTIT |
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Scientific title:
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Assessment of Forced Titration to Reach the Effective Dose for Good Glycemic Control in Lantus Treated Type 2 Patients |
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Date of first enrolment:
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May 2008 |
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Target sample size:
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241 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00701831 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group 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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Turkey
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Contacts
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Name:
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Zeynep Cetin |
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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:
- T2 insulin naïve patients
- Patients whom their physician is considering initiation of Lantus treatment
- Poor glycemic control 7,5 %10 %
- T2 treatment with OADs more than 3 months
- BMI<40 kg/m2
Exclusion Criteria:
- Impaired renal function (Cr>2mg/dl or current renal dialysis)
- Acute or chronic metabolic acidosis
- Active liver disease or serum ALT or AST >2,5 than normal
- History of hypoglycemia unawareness
- Diabetic retinopathy with surgery in the previous 3 months or planned within 3 months
after study entry
- Pregnancy, breast feeding
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
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: Insulin glargine
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Primary Outcome(s)
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Final dose
[Time Frame: after treatment end (6 months)]
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Time to dose titration
[Time Frame: after treatment end (6 months)]
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HbA1c, FBG
[Time Frame: after treatment end (6 months)]
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Number of dose adjustment
[Time Frame: after treatment end (6 months)]
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Secondary Outcome(s)
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DTSQ
[Time Frame: after treatment end (6 months)]
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Noctural hypoglycemia
[Time Frame: after treatment end (6 months)]
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Hypoglycemia
[Time Frame: after treatment end (6 months)]
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Physician Satisfaction Questionnaire
[Time Frame: after treatment end (6 months)]
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Secondary ID(s)
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LANTU_L_03502
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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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