NCT01421147

Brief Summary

The purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus when taken once daily in combination with insulin lispro before meals three times a day.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
536

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Aug 2011

Geographic Reach
9 countries

52 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

Study Start

First participant enrolled

August 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 9, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

1 year

First QC Date

August 19, 2011

Results QC Date

October 3, 2014

Last Update Submit

October 3, 2014

Conditions

Diabetes Mellitus, Type 1

Keywords

DiabetesType 1 DiabetesDiabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)

    HbA1c is the glycosylated fraction of hemoglobin A which provides an estimate of a participant's blood sugar control over a 6- to 12-week period. Least Squares (LS) means were calculated by analysis of covariance (ANCOVA) and adjusted for baseline HbA1c, treatment and time of basal insulin injection (daytime, evening/bedtime) and country.

    Baseline, Endpoint (up to 24 weeks)

Secondary Outcomes (12)

  • Change From Baseline in Insulin Antibody Levels

    Baseline, 6 weeks and 12 weeks and Endpoints (up to 24 weeks and up to 52 weeks)

  • Change From Baseline in Hemoglobin A1c (HbA1c)

    Baseline, 6 weeks and 12 weeks and 24 weeks and 36 weeks and 52 weeks and Endpoint (up to 52 weeks)

  • 7-Point Self-Monitored Blood Glucose (SMBG) Profiles

    Baseline and Endpoints [up to 24 weeks (wk) and up to 52 weeks]

  • Glycemic Variability of Fasting Blood Glucose

    Baseline and Endpoints (up to 24 weeks and up 52 weeks)

  • Change From Baseline in Body Weight

    Baseline, 6 weeks and 12 weeks and 18 weeks and Endpoints (up to 24 weeks and up to 52 weeks)

  • +7 more secondary outcomes

Study Arms (2)

LY2963016 + Insulin Lispro

EXPERIMENTAL

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

Drug: LY2963016Drug: Insulin Lispro

Lantus + Insulin Lispro

ACTIVE COMPARATOR

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro. Insulin lispro titrated based on blood glucose readings, administered subcutaneously, three times a day for 52 weeks.

Drug: LantusDrug: Insulin Lispro

Interventions

LY2963016DRUG

Administered subcutaneously

LY2963016 + Insulin Lispro
LantusDRUG

Administered subcutaneously

Lantus + Insulin Lispro
Insulin LisproDRUG

Administered subcutaneously

LY2963016 + Insulin LisproLantus + Insulin Lispro

Eligibility Criteria

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

You may qualify if:

  • Have type 1 diabetes mellitus based on the disease diagnostic criteria \[World Health Organization (WHO) Classification\]
  • Have duration of diabetes greater than or equal to one year
  • Have Hemoglobin A1c (HbA1c) less than or equal to 11.0%
  • On basal-bolus insulin therapy for at least 1 year \[basal insulin must be once daily (QD) injection of human insulin isophane suspension (NPH), Lantus, or detemir and combined with mealtime injections of human regular insulin, or insulin analog lispro, aspart or glulisine\]
  • Have a body mass index (BMI) of less than or equal to 35 kilograms/square meter (kg/m²)

You may not qualify if:

  • Have had more than one episode of severe low blood sugar (defined as needing someone else to help because you had very low blood sugar) within the 6 months before entering the study
  • Have had more than one episode of diabetic ketoacidosis or emergency room visits for uncontrolled diabetes leading to hospitalization within the 6 months before entering the study
  • Have known hypersensitivity or allergy to any of the study insulins (insulin glargine or insulin lispro) or to excipients of the study insulins
  • Have significant renal, cardiac, gastrointestinal or liver disease
  • Have active cancer or cancer within the past 5 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (52)

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Birmingham, Alabama, 35294, United States

Location

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Hollywood, Florida, 33021, United States

Location

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New Port Richey, Florida, 34652, United States

Location

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West Palm Beach, Florida, 33401, United States

Location

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Atlanta, Georgia, 30303, United States

Location

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Roswell, Georgia, 30076, United States

Location

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Springfield, Illinois, 62704, 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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Lexington, Kentucky, 40503, United States

Location

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Metairie, Louisiana, 70006, United States

Location

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Kalamazoo, Michigan, 49048, United States

Location

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Omaha, Nebraska, 68131, United States

Location

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Nashua, New Hampshire, 03063, United States

Location

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Mineola, New York, 11501, United States

Location

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New Hyde Park, New York, 11040, United States

Location

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Syracuse, New York, 13210, United States

Location

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Asheville, North Carolina, 28803, United States

Location

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Austin, Texas, 78731, United States

Location

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Dallas, Texas, 75390, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Brussels, 1090, Belgium

Location

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Leuven, 3000, Belgium

Location

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Liège, 4000, Belgium

Location

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Fulda, 36037, Germany

Location

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Hamburg, 22607, Germany

Location

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Heidelberg, 69115, Germany

Location

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Saint Ingbert-Oberwürzbach, 66386, Germany

Location

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Athens, 11527, Greece

Location

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Haidari/Athens, 12462, Greece

Location

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Thessaloniki, 56429, Greece

Location

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Budapest, 1134, Hungary

Location

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Debrecen, 4032, Hungary

Location

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Salgótarján, 3100, Hungary

Location

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Fukuoka, 815-8555, Japan

Location

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Kanagawa, 235-0045, Japan

Location

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Kumamoto, 862-0976, Japan

Location

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Miyazaki, 880-0034, Japan

Location

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Nagasaki, 857-1195, Japan

Location

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Tokyo, 105-8471, Japan

Location

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Guadalajara, 44600, Mexico

Location

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Monterrey, 64461, Mexico

Location

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Puebla City, 72190, Mexico

Location

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Tampico, 89249, Mexico

Location

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Krakow, 31-530, Poland

Location

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Lodz, 90-153, Poland

Location

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Szczecin, 70-376, Poland

Location

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Bucharest, 020359, Romania

Location

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Galati, 800587, Romania

Location

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Iași, 700547, Romania

Location

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Oradea, 410025, Romania

Location

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Timișoara, 300182, Romania

Location

Related Publications (1)

  • Nishiyama H, Shingaki T, Suzuki Y, Ilag LL. Similar Intrapatient Blood Glucose Variability with LY2963016 and Lantus(R) Insulin Glargine in Patients with Type 1 (T1D) or Type 2 Diabetes, Including a Japanese T1D Subpopulation. Diabetes Ther. 2018 Aug;9(4):1469-1476. doi: 10.1007/s13300-018-0450-0. Epub 2018 May 31.

    PMID: 29855972DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

LY2963016 insulin glargineInsulin GlargineInsulin Lispro

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsInsulin, Short-Acting

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2011

First Posted

August 22, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2012

Study Completion

April 1, 2013

Last Updated

October 9, 2014

Results First Posted

October 9, 2014

Record last verified: 2014-10

Locations

DE(4)JP(6)PL(3)ME(4)BE(3)GR(3)HU(3)RO(5)US(21)