Study of Human Regular U-500 Insulin in Adult Participants With Type 2 Diabetes
NCT ID: NCT01774968
Last Updated: 2015-09-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
325 participants
INTERVENTIONAL
2013-02-28
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Human Regular U-500 Insulin TID
Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
Human Regular U-500 Insulin
Human Regular U-500 Insulin BID
U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
Human Regular U-500 Insulin
Interventions
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Human Regular U-500 Insulin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m\^2)
* Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
* Current U-100 insulin/analogue users on \>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
* Have a history of stable body weight for at least 3 months prior to study entry
* Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months
* Have used any weight loss drugs in the 3 months prior to study entry
* Have a history of bariatric surgery
* Have a history of malignancy other than basal cell or squamous cell skin cancer
* Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification
* Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable
Exclusion Criteria
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
* Have chronic kidney disease stage 4 and higher or history of renal transplantation
* Have history of more than 1 episode of severe hypoglycemia within the 6 months prior to study entry
* Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
* Have received U-500R in the 3 months prior to study entry
* Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
* Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
* Have an irregular sleep/wake cycle
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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.
Mobile, Alabama, United States
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Little Rock, Arkansas, United States
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Concord, California, United States
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Fresno, California, United States
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Jacksonville, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Honolulu, Hawaii, United States
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Idaho Falls, Idaho, United States
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Crystal Lake, Illinois, United States
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Des Moines, Iowa, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Columbia, Missouri, United States
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Springfield, Missouri, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Nashua, New Hampshire, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Beaumont, Texas, United States
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Dallas, Texas, United States
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Norfolk, Virginia, United States
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Federal Way, Washington, United States
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Olympia, Washington, United States
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Renton, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Bayamón, , Puerto Rico
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Las Lomas, , Puerto Rico
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
Countries
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References
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Kabul S, Hood RC, Duan R, DeLozier AM, Settles J. Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial. Health Qual Life Outcomes. 2016 Sep 30;14(1):139. doi: 10.1186/s12955-016-0541-4.
Mari A, Rosenstock J, Ma X, Li YG, Jackson JA. OPTIMIZED HUMAN REGULAR U-500 INSULIN TREATMENT IMPROVES beta-CELL FUNCTION IN SEVERELY INSULIN-RESISTANT PATIENTS WITH LONG-STANDING TYPE 2 DIABETES AND HIGH INSULIN REQUIREMENTS. Endocr Pract. 2015 Dec;21(12):1344-52. doi: 10.4158/EP15898.OR. Epub 2015 Aug 26.
Hood RC, Arakaki RF, Wysham C, Li YG, Settles JA, Jackson JA. TWO TREATMENT APPROACHES FOR HUMAN REGULAR U-500 INSULIN IN PATIENTS WITH TYPE 2 DIABETES NOT ACHIEVING ADEQUATE GLYCEMIC CONTROL ON HIGH-DOSE U-100 INSULIN THERAPY WITH OR WITHOUT ORAL AGENTS: A RANDOMIZED, TITRATION-TO-TARGET CLINICAL TRIAL. Endocr Pract. 2015 Jul;21(7):782-93. doi: 10.4158/EP15612.OR. Epub 2015 Mar 26.
Other Identifiers
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B5K-US-IBHC
Identifier Type: OTHER
Identifier Source: secondary_id
14838
Identifier Type: -
Identifier Source: org_study_id
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