An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT02561078
Last Updated: 2020-05-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
420 participants
INTERVENTIONAL
2015-10-20
2017-05-09
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 administered by CSII
Human regular U-500 insulin administered by CSII and titrated based on blood glucose readings for 26 weeks with a 2-week MDI lead-in.
Human regular U-500 insulin (CSII)
Administered SC
Human regular U-500 insulin administered by MDI
Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.
Human regular U-500 insulin (MDI)
Administered SC
Interventions
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Human regular U-500 insulin (CSII)
Administered SC
Human regular U-500 insulin (MDI)
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current TDD \>200 but ≤600 units of non U-500R insulin (MDI or CSII) and/or U-500R by MDI with syringe and vial for ≥3 months at entry.
* If TDD of U-500R and other insulins are combined, then insulin other than U-500R not to exceed 25% of TDD.
* HbA1c ≥7.5% and ≤12.0%.
* Body mass index ≥25 but ≤50 kilograms per meter squared.
* Have a history of stable body weight.
* Concomitant antihyperglycemic agent (AHA) therapy may include metformin (MET), dipeptidyl peptidase-4 inhibitors and/or pioglitazone.
* Approximately 64 to 96 subjects using glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose cotransporter 2 (SGLT2) inhibitors will be enrolled in Study Group B.
Exclusion Criteria
* Have obvious clinical or radiographic signs or symptoms of liver disease (except nonalcoholic fatty liver disease), cirrhosis, acute or chronic hepatitis, or alanine aminotransferase (ALT/SGPT) and/or aspartate aminotransferase (AST/SGOT) levels ≥2.5X upper limit of normal (ULN), alkaline phosphatase ≥2X ULN or total bilirubin ≥2X ULN.
* 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 screening.
* Have received U-500R insulin by CSII in the 3 months prior to screening.
* Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
* Are taking chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy.
* Have an irregular sleep/wake cycle.
* Have used any weight loss drugs in the 3 months prior to screening.
* Have a history of bariatric surgery including Roux-en-Y gastric bypass surgery, gastric banding, and/or gastric sleeve.
* Have a history of an active or untreated malignancy, or in remission from a clinically significant malignancy during the last 5 years before screening.
* Significant hearing loss and/or vision impairment deemed by the investigator to interfere with the safe use of OmniPod U-500 system.
* Have cardiac disease with functional status that is New York Heart Association (NYHA) Class III or IV per New York Heart Association Cardiac Disease Functional Classification or have congestive heart failure requiring pharmacologic treatment.
* Are women breastfeeding or pregnant, or intend to become pregnant during the course of the study; are men who intend to impregnate their partners; or are sexually active of procreation potential not actively practicing birth control by a method determined by the investigator to be medically acceptable. Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
18 Years
85 Years
ALL
No
Sponsors
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Insulet Corporation
INDUSTRY
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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Internal Medicine Center LLC
Mobile, Alabama, United States
John Muir Physician Network Clinical Research Center
Concord, California, United States
Valley Endocrine, Fresno
Fresno, California, United States
Scripps Whittier Diabetes Institute
La Jolla, California, United States
Diabetes and Endocrine Associates
La Mesa, California, United States
First Valley Medical Group
Lancaster, California, United States
Pacific Research Partners, LLC
Oakland, California, United States
Inland Empire Liver Foundation
Rialto, California, United States
NorCal Endocrinology and Internal Medicine - Roseville
Roseville, California, United States
NorCal Endocrinology and Internal Medicine - Roseville
San Ramon, California, United States
Olive View Medical Center
Sylmar, California, United States
ALL Medical Research, LLC
Cooper City, Florida, United States
East Coast Institute For Research, LLC
Jacksonville, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Metabolic Research Institute Inc.
West Palm Beach, Florida, United States
East Coast Institute For Research, LLC
Macon, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center
Idaho Falls, Idaho, United States
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States
Midwest CRC
Crystal Lake, Illinois, United States
HSHS Medical Group Diabetes Research
Springfield, Illinois, United States
Iderc, P.L.C.
Des Moines, Iowa, United States
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, United States
Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
The Arthritis & Diabetes Clinic Inc.
Monroe, Louisiana, United States
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, United States
Adult Endocrinology Consultants, P.C.
Livonia, Michigan, United States
JCMG Clinical Research
Jefferson City, Missouri, United States
Billings Clinic Research Center
Billings, Montana, United States
Diabetes and Endocrinology Associates
Omaha, Nebraska, United States
Palm Research Center
Las Vegas, Nevada, United States
Palm Research Center
Las Vegas, Nevada, United States
Southern New Hampshire Diabetes and Endocrinology
Nashua, New Hampshire, United States
North Shore Diabetes and Endocrine Assoc
New Hyde Park, New York, United States
Mountain Diabetes and Endocrine Center
Asheville, North Carolina, United States
Physicians East
Greenville, North Carolina, United States
PMG Research of Rocky Mount, LLC
Rocky Mount, North Carolina, United States
University of Oklahoma Health Sciences Center-Tulsa
Oklahoma City, Oklahoma, United States
Portland Diabetes & Endocrine Center
Portland, Oregon, United States
Endocrine Metabolic Associates, P.C.
Philadelphia, Pennsylvania, United States
Partners in Nephrology & Endocrinology
Pittsburgh, Pennsylvania, United States
Sudhir Bansal M.D. Inc.
Warwick, Rhode Island, United States
AM Diabetes and Endocrinology Center
Bartlett, Tennessee, United States
University Diabetes and Endocrine Consultants
Chattanooga, Tennessee, United States
Vanderbilt Univeristy School of Medicine
Nashville, Tennessee, United States
Texas Diabetes and Endocrinology-Austin South
Austin, Texas, United States
Dallas Diabetes Endocrine Center
Dallas, Texas, United States
Texas Diabetes and Endocrinology, P.A.
Round Rock, Texas, United States
Advanced Research Institute
South Ogden, Utah, United States
Dr. Larry Stonesifer
Federal Way, Washington, United States
Rainier Clinical Research Center
Renton, Washington, United States
Northside Internal Medicine
Spokane, Washington, United States
Multicare Health System
Tacoma, Washington, United States
Dr Altagracia Aurora Alcantara Gonzalez
Bayamón, , Puerto Rico
Manati Center for Clinical Research Inc
Manatí, , Puerto Rico
Endocrine Lipid Diabetes Research Institute
Ponce, , Puerto Rico
American Telemedicine Center
San Juan, , Puerto Rico
Martha Gomez Cuellar M.D.
San Juan, , Puerto Rico
Countries
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Provided Documents
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Document Type: Study Protocol: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Study Protocol: Study Protocol (a)
Related Links
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Click here for more information about this study: An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
Other Identifiers
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B5K-MC-IBHD
Identifier Type: OTHER
Identifier Source: secondary_id
14902
Identifier Type: -
Identifier Source: org_study_id
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