NCT01774968

Brief Summary

The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
325

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2013

Geographic Reach
2 countries

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
8 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1 year until next milestone

Results Posted

Study results publicly available

May 12, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

1.2 years

First QC Date

January 22, 2013

Results QC Date

April 24, 2015

Last Update Submit

September 3, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)

    Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or \>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.

    Baseline, Week 24

Secondary Outcomes (14)

  • Percentage of Participants Achieving HbA1c of ≤6.5%, <7.0%, <7.5%, and <8.0% at Week 24

    Week 24

  • 30-Day Adjusted Rate of Hypoglycemic Events

    Baseline through Week 24

  • Change From Baseline to Week 24 in Body Weight

    Baseline, Week 24

  • Change From Baseline to Week 24 in Total Daily Dose (TDD; Units) of Insulin

    Baseline, Week 24

  • Change From Baseline to Week 24 in Total Daily Dose (TDD; Units/kg) of Insulin

    Baseline, Week 24

  • +9 more secondary outcomes

Study Arms (2)

Human Regular U-500 Insulin TID

EXPERIMENTAL

Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.

Drug: Human Regular U-500 Insulin

Human Regular U-500 Insulin BID

EXPERIMENTAL

U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.

Drug: Human Regular U-500 Insulin

Interventions

Human Regular U-500 InsulinDRUG
Also known as: LY041001, Humulin R, U-500R
Human Regular U-500 Insulin BIDHuman Regular U-500 Insulin TID

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have type 2 diabetes mellitus (World Health Organization \[WHO\] Classification of Diabetes)
  • Have a body mass index (BMI) ≥25 kilogram per square meter (kg/m\^2)
  • Have Glycated Hemoglobin A1c (HbA1c) ≥7.5% and ≤12.0%, as measured by the central laboratory at entry
  • Current U-100 insulin/analogue users on \>200 and ≤600 units per day for ≥3 months at study entry and reconfirmed at randomization
  • Have a history of stable body weight for at least 3 months prior to study entry
  • Concomitant medications may include metformin (MET), dipeptidyl peptidase-4 (DPP-4) inhibitors approved for use with insulin at time of study entry (for example, sitagliptin, saxagliptin, and linagliptin), pioglitazone, and/or sulfonylureas (SUs)/glinides (repaglinide or nateglinide). Participant's oral antihyperglycemic drug (OAD) dose(s) must have been stable for ≥3 months

You may not qualify if:

  • Have type 1 diabetes mellitus or other types of diabetes mellitus apart from type 2 diabetes mellitus
  • Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range
  • 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 study entry
  • Have received insulin by continuous subcutaneous insulin infusion in the 3 months prior to study entry
  • Have received U-500R in the 3 months prior to study entry
  • Have had a blood transfusion or severe blood loss within 3 months prior to study entry or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia
  • Are taking chronic systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to study entry
  • Have an irregular sleep/wake cycle
  • Have used any weight loss drugs in the 3 months prior to study entry
  • Have a history of bariatric surgery
  • Have a history of malignancy other than basal cell or squamous cell skin cancer
  • Have New York Heart Association (NYHA) Class III or IV per NYHA Cardiac Disease Functional Classification
  • Are breastfeeding or pregnant, or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Mobile, Alabama, 36617, United States

Location

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Little Rock, Arkansas, 72205, United States

Location

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Concord, California, 94520, United States

Location

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Fresno, California, 93720, United States

Location

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Jacksonville, Florida, 32216, United States

Location

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Tampa, Florida, 33619, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Honolulu, Hawaii, 96813, United States

Location

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Idaho Falls, Idaho, 83404, United States

Location

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Crystal Lake, Illinois, 60012, United States

Location

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Des Moines, Iowa, 50314, United States

Location

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Topeka, Kansas, 66606, United States

Location

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Louisville, Kentucky, 40206, United States

Location

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Bangor, Maine, 04401, United States

Location

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Baltimore, Maryland, 21204, United States

Location

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Columbia, Missouri, 65212, United States

Location

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Springfield, Missouri, 65807, United States

Location

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Omaha, Nebraska, 68131, United States

Location

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Las Vegas, Nevada, 89148, United States

Location

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Nashua, New Hampshire, 03063, United States

Location

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Durham, North Carolina, 27713, United States

Location

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Greenville, North Carolina, 27834, United States

Location

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Oklahoma City, Oklahoma, 73104, United States

Location

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Philadelphia, Pennsylvania, 19107, United States

Location

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Pittsburgh, Pennsylvania, 15224, United States

Location

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Chattanooga, Tennessee, 37411, United States

Location

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Nashville, Tennessee, 37212, United States

Location

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Beaumont, Texas, 77701, United States

Location

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Dallas, Texas, 75390, United States

Location

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Norfolk, Virginia, 23507, United States

Location

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Federal Way, Washington, 98003, United States

Location

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Olympia, Washington, 98502, United States

Location

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Renton, Washington, 98057, United States

Location

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Spokane, Washington, 99202, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Bayamón, 00956, Puerto Rico

Location

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Las Lomas, 00921, Puerto Rico

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00917-3104, Puerto Rico

Location

Related Publications (3)

  • Kabul S, Hood RC, Duan R, DeLozier AM, Settles J. Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial. Health Qual Life Outcomes. 2016 Sep 30;14(1):139. doi: 10.1186/s12955-016-0541-4.

    PMID: 27716283DERIVED

  • Mari A, Rosenstock J, Ma X, Li YG, Jackson JA. OPTIMIZED HUMAN REGULAR U-500 INSULIN TREATMENT IMPROVES beta-CELL FUNCTION IN SEVERELY INSULIN-RESISTANT PATIENTS WITH LONG-STANDING TYPE 2 DIABETES AND HIGH INSULIN REQUIREMENTS. Endocr Pract. 2015 Dec;21(12):1344-52. doi: 10.4158/EP15898.OR. Epub 2015 Aug 26.

    PMID: 26307903DERIVED

  • Hood RC, Arakaki RF, Wysham C, Li YG, Settles JA, Jackson JA. TWO TREATMENT APPROACHES FOR HUMAN REGULAR U-500 INSULIN IN PATIENTS WITH TYPE 2 DIABETES NOT ACHIEVING ADEQUATE GLYCEMIC CONTROL ON HIGH-DOSE U-100 INSULIN THERAPY WITH OR WITHOUT ORAL AGENTS: A RANDOMIZED, TITRATION-TO-TARGET CLINICAL TRIAL. Endocr Pract. 2015 Jul;21(7):782-93. doi: 10.4158/EP15612.OR. Epub 2015 Mar 26.

    PMID: 25813411DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
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 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

September 22, 2015

Results First Posted

May 12, 2015

Record last verified: 2015-09

Locations

PR(4)US(35)