4 T STUDY

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Author:
Susanslcm
ID:
45210
Filename:
4 T STUDY
Updated:
2010-10-26 17:35:06
Tags:
HOLMAN STUDY
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4 T STUDY BY HOLMAN
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  1. HOW LONG WAS THE 4 T STUDY?
    3 YEARS
  2. HOW MANY PATIENTS WERE IN THE 4 T STUDY?
    • 708 PATIENTS
    • 234 IN THE LEVEMIR ARM
    • 235 IN THE BIPHASIC ARM
    • 239 IN THE NOVOLOG ARM
  3. CRITERIA FOR INCLUSION IN THE 4 T STUDY?
    • 18 YEARS OR OLDER
    • NO PRIOR TREATMENT WITH INSULIN
    • 12 MONTHS OF T2 HISTORY

    EXCLUDED FOR PRIOR TREATMENT WITH TZD, OR TRIPLE OAD THERAPY WITHIN LAST 6 MONTHS
  4. WHEN WERE THE PATIENTS INTENSIFIED?
    AT OR AFTER 24 WEEKS:

    • IF A1C IS >10% for one measurement
    • if a1c is >8% for two consecitive measurments
    • IF AFTER 1 YEAR A1C IS >6.5%
  5. WHAT WAS THE A1C REDUCTION IN THE 4 T STUDY?
    1.2 REDUCTION IN AIC FROM BASELINT
  6. HOW MANY PATIENTS REACHED A1C GOAL IN THE 4 T STUDY?
    63% OF THE PATIENTS REACHED A1C GOAL.
  7. WHAT WAS THE MEAN A1C IN THE 4 T STUDY AT THE END 3YEARS?
    6.9 % A1C WAS THE MEADIAN A1C
  8. WHAT WAS THE HYPO PERCENT IN THE 4 T STUDY?
    MINOR 1.7

    MAJOR <1
  9. WHERE WAS THE 4 T STUDY PUBLISHED?
    N E JOURNAL 2009. AT THE END OF 3 YEARS ONLY
  10. HOW WAS NOVOLOG DOSED IN THE 4 T STUDY?
    10% OF THE BASIL DOSE WITHOUT REDUCING BASIL DOSE, AT BEDTIME OR DINNER.

    MIN OF 4 UNITS MAX OF 6 UNITS PER MEAL
  11. WHAT WAS THE STUDY DESIGN OF THE 4 T STUDY?
    RANDOMIZED, OPEN-LABEL MULTI CENTER
  12. HOW MANY TOTAL PATIENTS IN THE 4 T STUDY
    708 PATIENTS

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