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

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT02561078

Run by

Eli Lilly and Company

People needed

420

Starts

2015-10-20

Expected to finish

2017-05-09

Last updated by the study team

2020-05-20

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Internal Medicine Center LLC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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