The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin...
Date First Received: May 6, 2005
Last Updated: November 26, 2007
Verified by: Eli Lilly and Company, November 2007
Clinical Trial Phase: Phase 4 | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 300
Brief Summary
Official Title: “A Comparison of Prandial Insulin Lispro Mixtures Therapy to Glargine Basal-Bolus Therapy With Insulin Lispro on the Overall Glycemic Control of Patients With Type 2 Diabetes Previously Treated With Oral Agents Combined With Insulin Glargine”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to compare Lispro Mixture Therapy (insulin lispro 50/50 given three times daily with meals) to Glargine Basal-Bolus Therapy (insulin glargine daily with the addition of insulin lispro given three times daily with meals). The study is also comparing two different methods for adjusting the dose of insulin.
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Lispro Mixture Therapy
- Drug: Glargine Basal-Bolus Therapy
Outcome Measures for this Clinical Trial
Primary Measures
- To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
- in overall glycemic control (lower A1CF) at endpoint compared to to Glargine Basal-Bolus Therapy in combination
- with OADs in patients with type 2 diabetes who have clearly failed to achieve glycemic goal
- (A1C less than 7%) with once-daily insulin glargine in combination with OADs.
Secondary Measures
- To test in both arms the following: frequency and incidence
- of self-reported hypoglycemia, blood glucose data, 8-point profiles, insulin dose,
- body weight, SAE's and study drug related AEs.
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Must have type 2 diabetes.
- Must be 30-75 years of age at the time of Visit 1.
- Must be on insulin glargine and oral antidiabetic medicines for at least 90 days.
- Must be on at least 30 units of glargine per day at enrollment.
- Have an A1C between 7.5% and 12.0% at Visit 1.
Exclusion Criteria:
- Must not have used rapid/short-acting insulin on a regular basis in the last 6 months.
- Must not have more than one episode of severe hypoglycemia in the last 6 months.
- Must not have a body mass index (BMI) of greater than 45 (morbid obesity).
- Must not have congestive heart failure that requires medications.
- Must not have had a kidney transplant or currently receiving dialysis
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 30 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Eli Lilly and Company
Overall Clinical Trial Officials and Contacts
Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri from 9AM to 5PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company
Additional Information
Information obtained from ClinicalTrials.gov on October 07, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00110370
Study ID Number: 9057
ClinicalTrials.gov Identifier: NCT00110370
Health Authority: United States: Food and Drug Administration
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