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

NCT02561078 | Completed Phase 3 Results DMC

• 2 other identifiers: 14902B5K-MC-IBHD
• Study Type: interventional
• Target: 420
• Locations: 2 countries
• Sites: 57

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin pumps; concentrated insulin; OmniPod

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c)

  HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline of response, glucagon-like peptide-1 (GLP-1) or sodium-glucose cotransporter 2 (SGLT2) use, U-500R at entry, treatment, time and treatment by time interaction.

  Baseline, 26 Weeks

Secondary Outcomes (8)

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Baseline, 26 Weeks

• Percentage of Participants With HbA1c <7.0%

  26 Weeks

• Percentage of Participants With HbA1c <7.5%

  26 Weeks

• Change From Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values

  Baseline, 26 Weeks

• Change From Baseline in Total Daily Dose (TDD)

  Baseline, 26 Weeks

Study Arms (2)

Human regular U-500 insulin administered by CSII

EXPERIMENTAL

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.

Drug: Human regular U-500 insulin (CSII)

Human regular U-500 insulin administered by MDI

ACTIVE COMPARATOR

Human regular U-500 insulin administered subcutaneously (SC) by MDI three times a day and titrated based on blood glucose readings for 26 weeks.

Drug: Human regular U-500 insulin (MDI)

Interventions

Human regular U-500 insulin (CSII) DRUG

Administered SC

Also known as: LY041001

Human regular U-500 insulin administered by CSII

Human regular U-500 insulin (MDI) DRUG

Administered SC

Also known as: LY041001

Human regular U-500 insulin administered by MDI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Insulet Corporation: collaborator

Study Sites (57)

Internal Medicine Center LLC

Mobile, Alabama, 36608, United States

Location

John Muir Physician Network Clinical Research Center

Concord, California, 94520, United States

Location

Valley Endocrine, Fresno

Fresno, California, 93720, United States

Location

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

Diabetes and Endocrine Associates

La Mesa, California, 91942, United States

Location

First Valley Medical Group

Lancaster, California, 93534, United States

Location

Pacific Research Partners, LLC

Oakland, California, 94607, United States

Location

Inland Empire Liver Foundation

Rialto, California, 92377, United States

Location

NorCal Endocrinology and Internal Medicine - Roseville

Roseville, California, 95661, United States

Location

NorCal Endocrinology and Internal Medicine - Roseville

San Ramon, California, 94583, United States

Location

Olive View Medical Center

Sylmar, California, 91342, United States

Location

ALL Medical Research, LLC

Cooper City, Florida, 33024, United States

Location

East Coast Institute For Research, LLC

Jacksonville, Florida, 32216, United States

Location

Suncoast Clinical Research

New Port Richey, Florida, 34652, United States

Location

Metabolic Research Institute Inc.

West Palm Beach, Florida, 33401, United States

Location

East Coast Institute For Research, LLC

Macon, Georgia, 31210, United States

Location

Rocky Mountain Diabetes and Osteoporosis Center

Idaho Falls, Idaho, 83404, United States

Location

John H. Stroger Hospital of Cook County

Chicago, Illinois, 60612, United States

Location

Midwest CRC

Crystal Lake, Illinois, 60012, United States

Location

HSHS Medical Group Diabetes Research

Springfield, Illinois, 62711, United States

Location

Iderc, P.L.C.

Des Moines, Iowa, 50314, United States

Location

Cotton O'Neil Diabetes and Endocrinology Center

Topeka, Kansas, 66606, United States

Location

Kentucky Diabetes Endocrinology Center

Lexington, Kentucky, 40503, United States

Location

The Arthritis & Diabetes Clinic Inc.

Monroe, Louisiana, 71203, United States

Location

Grunberger Diabetes Institute

Bloomfield Hills, Michigan, 48302, United States

Location

Adult Endocrinology Consultants, P.C.

Livonia, Michigan, 48154, United States

Location

JCMG Clinical Research

Jefferson City, Missouri, 65109, United States

Location

Billings Clinic Research Center

Billings, Montana, 59101, United States

Location

Diabetes and Endocrinology Associates

Omaha, Nebraska, 68114, United States

Location

Palm Research Center

Las Vegas, Nevada, 89128, United States

Location

Palm Research Center

Las Vegas, Nevada, 89148, United States

Location

Southern New Hampshire Diabetes and Endocrinology

Nashua, New Hampshire, 03063, United States

Location

North Shore Diabetes and Endocrine Assoc

New Hyde Park, New York, 11040, United States

Location

Mountain Diabetes and Endocrine Center

Asheville, North Carolina, 28803, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

PMG Research of Rocky Mount, LLC

Rocky Mount, North Carolina, 27804, United States

Location

University of Oklahoma Health Sciences Center-Tulsa

Oklahoma City, Oklahoma, 73104, United States

Location

Portland Diabetes & Endocrine Center

Portland, Oregon, 97210, United States

Location

Endocrine Metabolic Associates, P.C.

Philadelphia, Pennsylvania, 19114, United States

Location

Partners in Nephrology & Endocrinology

Pittsburgh, Pennsylvania, 15224, United States

Location

Sudhir Bansal M.D. Inc.

Warwick, Rhode Island, 02886, United States

Location

AM Diabetes and Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

University Diabetes and Endocrine Consultants

Chattanooga, Tennessee, 37411, United States

Location

Vanderbilt Univeristy School of Medicine

Nashville, Tennessee, 37232, United States

Location

Texas Diabetes and Endocrinology-Austin South

Austin, Texas, 78749, United States

Location

Dallas Diabetes Endocrine Center

Dallas, Texas, 75230, United States

Location

Texas Diabetes and Endocrinology, P.A.

Round Rock, Texas, 78681, United States

Location

Advanced Research Institute

South Ogden, Utah, 84405, United States

Location

Dr. Larry Stonesifer

Federal Way, Washington, 98003, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Northside Internal Medicine

Spokane, Washington, 99208, United States

Location

Multicare Health System

Tacoma, Washington, 98405, United States

Location

Dr Altagracia Aurora Alcantara Gonzalez

Bayamón, 00956, Puerto Rico

Location

Manati Center for Clinical Research Inc

Manatí, 00674, Puerto Rico

Location

Endocrine Lipid Diabetes Research Institute

Ponce, 00717, Puerto Rico

Location

American Telemedicine Center

San Juan, 00917, Puerto Rico

Location

Martha Gomez Cuellar M.D.

San Juan, 00921, Puerto Rico

Location

Related Links

• 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 25, 2015
• Study Start: October 20, 2015
• Primary Completion: May 9, 2017
• Study Completion: May 9, 2017
• Last Updated: May 20, 2020
• Results First Posted: May 20, 2020

Record last verified: 2018-08

Locations

PR (5); US (52)