Clinical trial NCT02561078: An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin pumps
concentrated insulin
OmniPod
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Insulet Corporation
First posted: 2015-09-25
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, 26 Weeks
Secondary outcomes:
measure: Change From Baseline in Fasting Plasma Glucose (FPG)
timeFrame: Baseline, 26 Weeks
measure: Percentage of Participants With HbA1c <7.0%
timeFrame: 26 Weeks
measure: Percentage of Participants With HbA1c <7.5%
timeFrame: 26 Weeks
measure: Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values
timeFrame: Baseline, 26 Weeks
measure: Change From Baseline in Total Daily Dose (TDD)
timeFrame: Baseline, 26 Weeks
measure: Percentage of Participants With Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
timeFrame: 26 Weeks
measure: Rate of Hypoglycemic Episodes (Documented Hypoglycemia With Blood Glucose <= 70 mg/dL)
timeFrame: Baseline to 26 Weeks
measure: Change From Baseline in Body Weight
timeFrame: Baseline, 26 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Internal Medicine Center LLC
state: Alabama
city: Concord
country: United States
facility: John Muir Physician Network Clinical Research Center
state: California
city: Fresno
country: United States
facility: Valley Endocrine, Fresno
state: California
city: La Jolla
country: United States
facility: Scripps Whittier Diabetes Institute
state: California
city: La Mesa
country: United States
facility: Diabetes and Endocrine Associates
state: California
city: Lancaster
country: United States
facility: First Valley Medical Group
state: California
city: Oakland
country: United States
facility: Pacific Research Partners, LLC
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Roseville
country: United States
facility: NorCal Endocrinology and Internal Medicine - Roseville
state: California
city: San Ramon
country: United States
facility: NorCal Endocrinology and Internal Medicine - Roseville
state: California
city: Sylmar
country: United States
facility: Olive View Medical Center
state: California
city: Cooper City
country: United States
facility: ALL Medical Research, LLC
state: Florida
city: Jacksonville
country: United States
facility: East Coast Institute For Research, LLC
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: West Palm Beach
country: United States
facility: Metabolic Research Institute Inc.
state: Florida
city: Macon
country: United States
facility: East Coast Institute For Research, LLC
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Diabetes and Osteoporosis Center
state: Idaho
city: Chicago
country: United States
facility: John H. Stroger Hospital of Cook County
state: Illinois
city: Crystal Lake
country: United States
facility: Midwest CRC
state: Illinois
city: Springfield
country: United States
facility: HSHS Medical Group Diabetes Research
state: Illinois
city: Des Moines
country: United States
facility: Iderc, P.L.C.
state: Iowa
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes and Endocrinology Center
state: Kansas
city: Lexington
country: United States
facility: Kentucky Diabetes Endocrinology Center
state: Kentucky
city: Monroe
country: United States
facility: The Arthritis & Diabetes Clinic Inc.
state: Louisiana
city: Bloomfield Hills
country: United States
facility: Grunberger Diabetes Institute
state: Michigan
city: Livonia
country: United States
facility: Adult Endocrinology Consultants, P.C.
state: Michigan
city: Jefferson City
country: United States
facility: JCMG Clinical Research
state: Missouri
city: Billings
country: United States
facility: Billings Clinic Research Center
state: Montana
city: Omaha
country: United States
facility: Diabetes and Endocrinology Associates
state: Nebraska
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center
state: Nevada
city: Nashua
country: United States
facility: Southern New Hampshire Diabetes and Endocrinology
state: New Hampshire
city: New Hyde Park
country: United States
facility: North Shore Diabetes and Endocrine Assoc
state: New York
city: Asheville
country: United States
facility: Mountain Diabetes and Endocrine Center
state: North Carolina
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center-Tulsa
state: Oklahoma
city: Portland
country: United States
facility: Portland Diabetes & Endocrine Center
state: Oregon
city: Philadelphia
country: United States
facility: Endocrine Metabolic Associates, P.C.
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Partners in Nephrology & Endocrinology
state: Pennsylvania
city: Warwick
country: United States
facility: Sudhir Bansal M.D. Inc.
state: Rhode Island
city: Bartlett
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Chattanooga
country: United States
facility: University Diabetes and Endocrine Consultants
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univeristy School of Medicine
state: Tennessee
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology-Austin South
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Endocrine Center
state: Texas
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology, P.A.
state: Texas
city: South Ogden
country: United States
facility: Advanced Research Institute
state: Utah
city: Federal Way
country: United States
facility: Dr. Larry Stonesifer
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Spokane
country: United States
facility: Northside Internal Medicine
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System
state: Washington
city: Bayamon
country: Puerto Rico
facility: Dr Altagracia Aurora Alcantara Gonzalez
city: Manati
country: Puerto Rico
facility: Manati Center for Clinical Research Inc
city: Ponce
country: Puerto Rico
facility: Endocrine Lipid Diabetes Research Institute
city: San Juan
country: Puerto Rico
facility: American Telemedicine Center
city: San Juan
country: Puerto Rico
facility: Martha Gomez Cuellar M.D.
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: