Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
588 participants
INTERVENTIONAL
2006-05-31
2010-03-31
Brief Summary
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* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60
* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c
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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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Lantus/Apidra-3
Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Insulin Glargine
Subcutaneous injection once-a-day
Insulin Glulisine
Subcutaneous injection up to 3 injections per day.
Lantus/Apidra-1
Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
Insulin Glulisine
Subcutaneous injection up to 1 injection per day
Insulin Glargine
Subcutaneous injection once-a-day
Novolog Mix 70/30
Premixed insulin (Novolog® Mix 70/30) added to oral agents.
Premixed Insulin
Subcutaneous injection twice-a-day.
Interventions
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Insulin Glulisine
Subcutaneous injection up to 1 injection per day
Insulin Glargine
Subcutaneous injection once-a-day
Premixed Insulin
Subcutaneous injection twice-a-day.
Insulin Glulisine
Subcutaneous injection up to 3 injections per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 30 to 80 years of age
* Body Mass Index \<45 kg/m2
* With Type 2 diabetes mellitus for at least 2 years
* With an HbA1c level at screening of \>7.5% and \>7.0% at randomization
* On stable dual or triple oral therapy for at least 3 months
* Oral agents in 2 or 3 of the following classes: SU or repaglinide, biguanide, or TZD, willing and able to perform self-monitoring of BG
* Females of child-bearing potentially were required to be willing and able to use adequate contraception
30 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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Medical Affairs
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States
Countries
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References
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Polonsky WH, Thompson S, Wei W, Riddle MC, Chaudhari S, Jackson J, Bruno AS. Greater fear of hypoglycaemia with premixed insulin than with basal-bolus insulin glargine and glulisine: patient-reported outcomes from a 60-week randomised study. Diabetes Obes Metab. 2014 Nov;16(11):1121-7. doi: 10.1111/dom.12328. Epub 2014 Jul 12.
Other Identifiers
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HMR1964A_3515
Identifier Type: -
Identifier Source: org_study_id
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