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Comparing Pre-mixed Insulin with Insulin Glargine Combined with Rapid-acting Insulin in Patients with Type 2 Diabetes - Article


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Insulin glargine

insulin glargine [rDNA origin]; Lantus

Clinical Trial: Comparing Pre-mixed Insulin with Insulin Glargine Combined with Rapid-acting Insulin in Patients with Type 2 Diabetes

This study is currently recruiting patients.

Sponsored by: Eli Lilly and Company
Information provided by: Eli Lilly and Company

Purpose

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.

Condition Treatment or Intervention Phase
Diabetes Mellitus, Type 2
  Drug: Lispro Mixture Therapy
 Drug: Glargine Basal-Bolus Therapy
 Phase IV

MedlinePlus related topics:  Diabetes

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label

Official Title: Comparing Pre-mixed Insulin at each of Three Meals with Once Daily Insulin Glargine Combined with Mealtime Rapid-acting Insulin in Patients with Type 2 Diabetes who were Previously Treated with Oral Agents and Insulin Glargine

Eligibility

Ages Eligible for Study:  30 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00110370

There may be multiple sites in this clinical trial      1-877-CTLILLY (1-877-285-4559) 

Alabama
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Birmingham,  Alabama,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Anniston,  Alabama,  United States; Recruiting

Arizona
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Phoenix,  Arizona,  United States; Recruiting

Arkansas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Jonesboro,  Arkansas,  United States; Recruiting

California
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., San Mateo,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., LaJolla,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Concord,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Orange,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., West Hills,  California,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Ingelwood,  California,  United States; Recruiting

Colorado
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Littleton,  Colorado,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Colorado Springs,  Colorado,  United States; Recruiting

Connecticut
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Norwich,  Connecticut,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Norwalk,  Connecticut,  United States; Recruiting

Delaware
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Newark,  Delaware,  United States; Recruiting

Florida
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Aventura,  Florida,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., West Palm Beach,  Florida,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Ft. Myers,  Florida,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Hollywood,  Florida,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Maitland,  Florida,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Melbourne,  Florida,  United States; Recruiting

Georgia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Atlanta,  Georgia,  United States; Recruiting

Hawaii
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Honolulu,  Hawaii,  United States; Recruiting

Kansas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Topeka,  Kansas,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Wichita,  Kansas,  United States; Recruiting

Kentucky
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lexington,  Kentucky,  United States; Recruiting

Louisiana
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., New Orleans,  Louisiana,  United States; Recruiting

Massachusetts
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Springfield,  Massachusetts,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Worcester,  Massachusetts,  United States; Recruiting

Michigan
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bloomfield,  Michigan,  United States; Recruiting

Missouri
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Jefferson City,  Missouri,  United States; Recruiting

Montana
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Butte,  Montana,  United States; Recruiting

Nebraska
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Omaha,  Nebraska,  United States; Recruiting

Nevada
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Reno,  Nevada,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Las Vegas,  Nevada,  United States; Recruiting

New Jersey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Princeton,  New Jersey,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., New Brunswick,  New Jersey,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., North Bergen,  New Jersey,  United States; Recruiting

New York
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Mineola,  New York,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Rochester,  New York,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Syracuse,  New York,  United States; Recruiting

North Carolina
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Raleigh,  North Carolina,  United States; Recruiting

Oklahoma
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Tulsa,  Oklahoma,  United States; Recruiting

Oregon
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Salem,  Oregon,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Portland,  Oregon,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Corvallis,  Oregon,  United States; Recruiting

Pennsylvania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Beaver,  Pennsylvania,  United States; Recruiting

South Carolina
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Greenville,  South Carolina,  United States; Recruiting

Tennessee
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Memphis,  Tennessee,  United States; Recruiting

Texas
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., San Antonio,  Texas,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Beaumont,  Texas,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Houston,  Texas,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Dallas,  Texas,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Irving,  Texas,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Austin,  Texas,  United States; Recruiting

Utah
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Salt Lake City,  Utah,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Ogden,  Utah,  United States; Recruiting

Vermont
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Burlington,  Vermont,  United States; Recruiting

Washington
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Spokane,  Washington,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Renton,  Washington,  United States; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Federal Way,  Washington,  United States; Recruiting

West Virginia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Charleston,  West Virginia,  United States; Recruiting

Puerto Rico
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Ponce,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., San Juan,  Puerto Rico; Recruiting

      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Manati,  Puerto Rico; Recruiting

More Information

Study ID Numbers:  9057
Record last reviewed:  May 2005
Last Updated:  May 9, 2005
Record first received:  May 6, 2005
ClinicalTrials.gov Identifier:  NCT00110370
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17


Source: ClinicalTrials.gov
Cache Date: May 18, 2005


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Page Updated: September 6, 2005
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