An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 85
Updated:8/23/2018
Start Date:October 2015
End Date:May 9, 2017

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Safety and Efficacy of Human Regular U-500 Insulin Administered by Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Subjects With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Parallel Clinical Trial

The main purpose of this study is to evaluate the efficacy and safety of the study drug known
as human regular U-500 insulin (U-500R) administered by continuous subcutaneous insulin
infusion (CSII) versus multiple daily injections (MDI) in participants with type 2 diabetes
mellitus.


Inclusion Criteria:

- Diagnosed with type 2 diabetes mellitus (T2DM).

- 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:

- Diagnosed with type 1 diabetes mellitus (T1DM) or other types of diabetes apart from
T2DM.

- 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.
We found this trial at
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Spokane, Washington 99208
Principal Investigator: Harold Cathcart
Phone: 509-444-7665
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1045 North 30th Street
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11701 San Jose Blvd # 32
Jacksonville, Florida 32223
Principal Investigator: Mae Sheikh-Ali
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Asheville, North Carolina 28803
Principal Investigator: Wendy Lane
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Austin, Texas 78749
Principal Investigator: Tira Chaicha-Brom
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Bartlett, Tennessee 38133
Principal Investigator: Kashif Latif
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Bayamon, 00956
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Bloomfield Hills, Michigan 48302
Principal Investigator: George Grunberger
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Chattanooga, Tennessee 37403
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Chicago, Illinois 60612
Principal Investigator: Leon Fogelfeld
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Concord, California 94520
Principal Investigator: Anna Chang
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Cooper City, Florida 33024
Principal Investigator: Lorena Lewy-Alterbaum
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Crystal Lake, Illinois 60012
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Dallas, Texas 75230
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Des Moines, Iowa 50314
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Federal Way, Washington 98003
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Fresno, California 93720
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Greenville, North Carolina 27834
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Idaho Falls, Idaho 83404
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Jefferson City, Missouri 65109
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La Jolla, California
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La Mesa, California 91942
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Lancaster, California 93534
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Las Vegas, Nevada 89102
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Las Vegas, Nevada 89102
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Lexington, Kentucky 40503
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Livonia, Michigan 48154
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Macon, Georgia 31210
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Mobile, Alabama 36608
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Monroe, Louisiana 71203
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Nashua, New Hampshire 03063
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Nashville, Tennessee 37212
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New Hyde Park, New York 11042
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New Port Richey, Florida 34652
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Philadelphia, Pennsylvania 19114
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Renton, Washington 98057
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Rialto, California 92377
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Round Rock, Texas 78681
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San Ramon, California 94583
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South Ogden, Utah 84405
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Springfield, Illinois 62711
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Sylmar, California 91342
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314 Martin Luther King Junior Way
Tacoma, Washington 98405
(253) 403-5200
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Topeka, Kansas 66606
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Warwick, Rhode Island 02886
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West Palm Beach, Florida
Principal Investigator: Barry Horowitz
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