Comparing Pre-Mixed Insulin With Insulin Glargine Combined With Rapid-Acting Insulin in Patients With Type 2 Diabetes

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00110370
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-05-06
• Study First Submitted QC: 2005-05-06
• Study First Posted: 2005-05-09
• Study Completion: 2006-04
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-26
• Last Update Posted: 2007-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To test the hypothesis that Lispro Mixtures Therapy regimen in combination with oral antihyperglycemic agents (OADs) is non-inferior
(A1C less than 7%) with once-daily insulin glargine in combination with OADs.
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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST) or speak with your personal physician.; 🇵🇷 Toa Baja, Puerto Rico