NCT00110370

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Apr 2004

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach
2 countries

48 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

May 6, 2005

Last Update Submit

November 26, 2007

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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.

Interventions

Lispro Mixture TherapyDRUG
Glargine Basal-Bolus TherapyDRUG

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (48)

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.

Anniston, Alabama, United States

Location

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Birmingham, Alabama, United States

Location

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Phoenix, Arizona, United States

Location

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Concord, California, United States

Location

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Inglewood, California, United States

Location

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La Jolla, California, United States

Location

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Orange, California, United States

Location

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West Hills, California, United States

Location

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Colorado Springs, Colorado, United States

Location

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Aventura, Florida, United States

Location

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Hollywood, Florida, United States

Location

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Maitland, Florida, United States

Location

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Melbourne, Florida, United States

Location

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West Palm Beach, Florida, United States

Location

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Topeka, Kansas, United States

Location

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Wichita, Kansas, United States

Location

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Lexington, Kentucky, United States

Location

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Metairie, Louisiana, United States

Location

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Springfield, Massachusetts, United States

Location

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Bloomfield Hills, Michigan, United States

Location

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Jefferson City, Missouri, United States

Location

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Butte, Montana, United States

Location

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Omaha, Nebraska, United States

Location

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Reno, Nevada, United States

Location

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New Brunswick, New Jersey, United States

Location

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Mineola, New York, United States

Location

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Syracuse, New York, United States

Location

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Raleigh, North Carolina, United States

Location

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Tulsa, Oklahoma, United States

Location

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Corvallis, Oregon, United States

Location

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Portland, Oregon, United States

Location

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Beaver, Pennsylvania, United States

Location

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Greenville, South Carolina, United States

Location

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Memphis, Tennessee, United States

Location

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Beaumont, Texas, United States

Location

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Dallas, Texas, United States

Location

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Houston, Texas, United States

Location

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Irving, Texas, United States

Location

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San Antonio, Texas, United States

Location

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Ogden, Utah, United States

Location

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Salt Lake City, Utah, United States

Location

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Federal Way, Washington, United States

Location

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Renton, Washington, United States

Location

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Charleston, West Virginia, United States

Location

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Manatí, Puerto Rico

Location

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Ponce, Puerto Rico

Location

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San Juan, Puerto Rico

Location

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Toa Baja, Puerto Rico

Location

Related Publications (2)

  • 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.

    PMID: 28667381DERIVED

  • 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.

    PMID: 17934150DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2005

First Posted

May 9, 2005

Study Start

April 1, 2004

Study Completion

April 1, 2006

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

PR(4)US(44)