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

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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Lispro Mixture Therapy; Drug: Glargine Basal-Bolus Therapy

• Study Type: Interventional
• Enrollment: 300
• Phase: Phase 4

Contacts and Locations

Study Locations

• Puerto Rico
  • Manati, Puerto Rico
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  • Ponce, Puerto Rico
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  • San Juan, Puerto Rico
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  • Toa Baja, Puerto Rico
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• United States
  • Alabama
    • Anniston, Alabama, United States
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    • Birmingham, Alabama, United States
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  • Arizona
    • Phoenix, Arizona, United States
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  • California
    • Concord, California, United States
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    • Inglewood, California, United States
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    • LaJolla, California, United States
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    • Orange, California, United States
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    • West Hills, California, United States
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  • Colorado
    • Colorado Springs, Colorado, United States
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  • Florida
    • Aventura, Florida, United States
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    • Hollywood, Florida, United States
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    • Maitland, Florida, United States
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    • Melbourne, Florida, United States
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    • West Palm Beach, Florida, United States
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  • Kansas
    • Topeka, Kansas, United States
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    • Wichita, Kansas, United States
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  • Kentucky
    • Lexington, Kentucky, United States
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  • Louisiana
    • Metairie, Louisiana, United States
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  • Massachusetts
    • Springfield, Massachusetts, United States
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  • Michigan
    • Bloomfield Hills, Michigan, United States
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  • Missouri
    • Jefferson City, Missouri, United States
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  • Montana
    • Butte, Montana, United States
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  • Nebraska
    • Omaha, Nebraska, United States
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  • Nevada
    • Reno, Nevada, United States
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  • New Jersey
    • New Brunswick, New Jersey, United States
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  • New York
    • Mineola, New York, United States
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    • Syracuse, New York, United States
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  • North Carolina
    • Raleigh, North Carolina, United States
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  • Oklahoma
    • Tulsa, Oklahoma, United States
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  • Oregon
    • Corvallis, Oregon, United States
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    • Portland, Oregon, United States
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  • Pennsylvania
    • Beaver, Pennsylvania, United States
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  • South Carolina
    • Greenville, South Carolina, United States
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  • Tennessee
    • Memphis, Tennessee, United States
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  • Texas
    • Beaumont, Texas, United States
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    • Dallas, Texas, United States
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    • Houston, Texas, United States
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    • Irving, Texas, United States
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    • San Antonio, Texas, United States
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  • Utah
    • Ogden, Utah, United States
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    • Salt Lake City, Utah, United States
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  • Washington
    • Federal Way, Washington, United States
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    • Renton, Washington, United States
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  • West Virginia
    • Charleston, West Virginia, United States
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Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Publications and helpful links

General Publications

• Shi LX, Li PF, Hou JN. Differential Treatment Response to Insulin Intensification Therapy: A Post Hoc Analysis of a Randomized Trial Comparing Premixed and Basal-Bolus Insulin Regimens. Diabetes Ther. 2017 Aug;8(4):915-928. doi: 10.1007/s13300-017-0286-z. Epub 2017 Jun 30.
• Rosenstock J, Ahmann AJ, Colon G, Scism-Bacon J, Jiang H, Martin S. Advancing insulin therapy in type 2 diabetes previously treated with glargine plus oral agents: prandial premixed (insulin lispro protamine suspension/lispro) versus basal/bolus (glargine/lispro) therapy. Diabetes Care. 2008 Jan;31(1):20-5. doi: 10.2337/dc07-1122. Epub 2007 Oct 12.

Helpful Links

• Lilly Clinical Trial Registry

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Study Completion (Actual): April 1, 2006

Study Registration Dates

• First Submitted: May 6, 2005
• First Submitted That Met QC Criteria: May 6, 2005
• First Posted (Estimate): May 9, 2005

Study Record Updates

• Last Update Posted (Estimate): November 27, 2007
• Last Update Submitted That Met QC Criteria: November 26, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin Glargine
• Other Study ID Numbers: 9057; F3Z-US-IOOQ