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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: |
NCT00551356 |
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Date of registration:
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29/10/2007 |
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Primary sponsor: |
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Public title:
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Lispro Mix 25 vs. Glargine in Type 2 Diabetics
IOOL |
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Scientific title:
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Comparison of the Insulin Therapies: Insulin Lispro Low Mix (25%) and Insulin Glargine in Patients With Diabetes Mellitus Type 2 |
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Date of first enrolment:
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November 2002 |
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Target sample size:
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53 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00551356 |
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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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Mexico
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Males or females who have type 2 diabetes between 1 and 10 years
- Have used diet and/or maximum doses of oral antidiabetic agents (combination) for the
treatment of their diabetes
- Have not been on insulin treatment within 3 months before entry into the study
- Have a hemoglobin A1c in the range of 8.0 to 12.5% according to a local laboratory
within 4 weeks prior to or at Visit 1
- Have a body mass index below 40 kg/m²
Exclusion Criteria:
- Receive chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy
(excluding topical and inhaled preparations) or have received such therapy within 2
weeks immediately prior to Visit 1
- Have a known allergy to insulin
- Have serum creatinine greater than or equal to 1.5 mg/dl as determined by a local
laboratory
- Have known proliferative retinopathy
- Have had more than one unexplained episode of severe hypoglycemia (defined as
requiring assistance of another person due to disabling hypoglycemia) within 6 months
prior to entering the study
Age minimum:
30 Years
Age maximum:
75 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: Glargine
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Drug: Insulin lispro mix 25
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Primary Outcome(s)
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Change from baseline to endpoint in 2h postprandial blood glucose excursion after breakfast
[Time Frame: 16 weeks or end of study.]
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Secondary Outcome(s)
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Body mass index (BMI)
[Time Frame: 16 weeks or end of study.]
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Body weight
[Time Frame: 16 weeks or end of study.]
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Change of hemoglobin A1c from baseline to endpoint
[Time Frame: 16 weeks or end of study.]
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Glycemic control as determined by self-monitored blood glucose concentrations
[Time Frame: 16 weeks or end of study.]
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Hemoglobin A1c measured at endpoint
[Time Frame: 16 weeks or end of study.]
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The incidence and rate of self-reported hypoglycemic episodes
[Time Frame: 16 weeks or end of study.]
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Total Insulin Doses
[Time Frame: 16 weeks or end of study.]
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Secondary ID(s)
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7354
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F3Z-ME-IOOL
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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