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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00384085 |
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Date of registration:
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03/10/2006 |
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Primary sponsor: |
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Public title:
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Insulin Glargine "All to Target" Trial
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Scientific title:
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All to Target Trial Lantus® (Insulin Glargine) With Stepwise Addition of APIDRA® (Insulin Glulisine) or Lantus With One Injection of Apidra vs a Twice-Daily Premixed Insulin Regimen (Novolog® Mix 70/30) in Adult Subjects With Type 2 Diabetes Failing Dual or Triple Therapy With Oral Agents: a 64-week, Multi-center, Randomized, Parallel, Open-label Clinical Study. |
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Date of first enrolment:
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May 2006 |
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Target sample size:
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588 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00384085 |
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Study type:
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Interventional |
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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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Countries of recruitment
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United States
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Contacts
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Name:
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Medical Affairs |
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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-Aventis |
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Key inclusion & exclusion criteria
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- Male or female patients
- 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
Age minimum:
30 Years
Age maximum:
80 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: Insulin Glargine
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Drug: Insulin Glulisine
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Drug: Premixed Insulin
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Primary Outcome(s)
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Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population
[Time Frame: At week 60]
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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)
[Time Frame: At week 60]
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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)
[Time Frame: At week 60]
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Secondary Outcome(s)
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Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)
[Time Frame: From baseline to week 60]
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Adjusted Hypoglycemic Event Rates (Event/Patient-year)
[Time Frame: Week 60]
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Adjusted Incidence Rate of Hypoglycemia
[Time Frame: Week 60]
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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)
[Time Frame: At week 60]
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Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl
[Time Frame: At week 60]
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Secondary ID(s)
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HMR1964A_3515
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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