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

NCT ID: NCT00110370

Last Updated: 2007-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2006-04-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Lispro Mixture Therapy

Intervention Type DRUG

Glargine Basal-Bolus Therapy

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Anniston, Alabama, United States

Site Status

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Birmingham, Alabama, United States

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Phoenix, Arizona, United States

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Concord, California, United States

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Inglewood, California, United States

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La Jolla, 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 Springs, Colorado, United States

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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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Topeka, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Metairie, Louisiana, United States

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Springfield, Massachusetts, United States

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Bloomfield Hills, Michigan, United States

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Jefferson City, Missouri, United States

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Butte, Montana, United States

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Omaha, Nebraska, United States

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Reno, Nevada, United States

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New Brunswick, New Jersey, United States

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Mineola, New York, United States

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Syracuse, New York, United States

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Raleigh, North Carolina, United States

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Tulsa, Oklahoma, United States

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Corvallis, Oregon, United States

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Portland, Oregon, United States

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Beaver, Pennsylvania, United States

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Greenville, South Carolina, United States

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Memphis, Tennessee, United States

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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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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Federal Way, Washington, United States

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Renton, Washington, United States

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Charleston, West Virginia, United States

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Manatí, , 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

Site Status

Countries

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United States Puerto Rico

References

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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.

Reference Type DERIVED
PMID: 28667381 (View on PubMed)

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.

Reference Type DERIVED
PMID: 17934150 (View on PubMed)

Other Identifiers

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F3Z-US-IOOQ

Identifier Type: -

Identifier Source: secondary_id

9057

Identifier Type: -

Identifier Source: org_study_id