NCT01421459

Brief Summary

The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
759

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
12 countries

62 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

August 19, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 9, 2014

Completed
Last Updated

December 18, 2014

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

August 19, 2011

Results QC Date

October 3, 2014

Last Update Submit

December 2, 2014

Conditions

Diabetes Mellitus, Type 2

Keywords

DiabetesType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline up to 24 Weeks 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 analysis of covariance (ANCOVA) and adjusted for Baseline HbA1c, country, sulfonylurea use, time of basal insulin injection and treatment.

    Baseline, Endpoint (up to 24 weeks)

Secondary Outcomes (12)

  • Change From Baseline in Insulin Antibody Levels

    Baseline and 4 weeks and 12 weeks and Endpoint (24 weeks and up to 24 weeks)

  • Change From Baseline in Hemoglobin A1c (HbA1c)

    Baseline and 4 weeks and 8 weeks and 12 weeks and 16 weeks and 20 weeks and 24 weeks

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

    Baseline and Endpoint [up to 24 weeks (wk)]

  • Glycemic Variability of Fasting Blood Glucose

    Baseline and Endpoint (up to 24 weeks)

  • Change From Baseline in Body Weight

    Baseline and 4 weeks (wk) and 8 wk and 12 wk and 16 wk and 20 wk and 24 wk and Endpoint (up to 24 wk)

  • +7 more secondary outcomes

Other Outcomes (2)

  • Percentage of Participants With Detectable Insulin Antibody Levels

    Baseline and 4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)

  • Percentage of Participants With Treatment Emergent Antibody Response (TEAR)

    4 weeks and 12 weeks and 24 weeks and Endpoint (up to 24 weeks) and Baseline to 24 weeks (Overall)

Study Arms (2)

LY2963016 + OAMs

EXPERIMENTAL

LY2963016 titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) \[alpha glucosidase inhibitors (AGI), dipeptidyl peptidases intravenous (DPP-IV), meglitinide (MEG), metformin (MET), sulfonylurea (SU), and thiazolidinedione (TZD)\] administered per standard of care for 24 weeks

Drug: LY2963016Drug: OAMs

Lantus + OAMs

ACTIVE COMPARATOR

Lantus titrated based on blood glucose readings, administered subcutaneously, once daily in combination with at least 2 OAMs (AGI, DPP-IV, MEG, MET, SU, and TZD) administered per standard of care for 24 weeks

Drug: LantusDrug: OAMs

Interventions

LY2963016DRUG

Administered subcutaneously

LY2963016 + OAMs
LantusDRUG

Administered subcutaneously

Lantus + OAMs
OAMsDRUG

Administered orally

LY2963016 + OAMsLantus + OAMs

Eligibility Criteria

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

You may qualify if:

  • Have Type 2 Diabetes Mellitus based on the disease diagnostic criteria World Health Organization (WHO) classification
  • Have been taking at least 2 types of oral diabetes medications for at least 12 weeks prior to entering the study
  • Have a Hemoglobin A1c value greater than or equal to 7.0 percent and less than or equal to 11.0 percent if insulin naive If previously on Lantus, then Hemoglobin A1c must be less than or equal to 11.0 percent
  • Have a body mass index of less than or equal to 45 kilogram per meter squared (kg/m\^2)

You may not qualify if:

  • Have significant liver, cardiac or gastrointestinal disease
  • Have active cancer or have had cancer within the past 5 years (with the exception of basal cell carcinoma or carcinoma in situ)
  • Have an excessive resistance to insulin or hypersensitivity to Lantus
  • 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 taken any other insulin other than Lantus within the past 30 days
  • Taking any other diabetes medicines that are not allowed in the study or not approved to be taken with insulin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (62)

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Montgomery, Alabama, 36106, United States

Location

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Brooksville, Florida, 34601, United States

Location

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Fort Lauderdale, Florida, 33316, United States

Location

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New Port Richey, Florida, 34652, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Pembroke Pines, Florida, 33028, United States

Location

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Tampa, Florida, 33617, United States

Location

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Atlanta, Georgia, 30329, United States

Location

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Roswell, Georgia, 30076, 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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Port Gibson, Mississippi, 39150, United States

Location

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Springfield, Missouri, 65807, United States

Location

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Omaha, Nebraska, 68114, 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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Salisbury, North Carolina, 28144, United States

Location

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Fargo, North Dakota, 58103, United States

Location

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Philadelphia, Pennsylvania, 19107, United States

Location

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Dallas, Texas, 75246, United States

Location

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Houston, Texas, 77074, United States

Location

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Hurst, Texas, 76054, United States

Location

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Longview, Texas, 75605, United States

Location

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Plano, Texas, 75093, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Brandýs nad Labem, 250 01, Czechia

Location

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Prague, 15500, Czechia

Location

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Nantes, 44300, France

Location

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Vieux-Condé, 59690, France

Location

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Aschaffenburg, 63739, Germany

Location

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Dresden, 01219, Germany

Location

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Giengen an der Brenz, 89537, Germany

Location

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Hamburg, 22607, Germany

Location

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Heidelberg, 69115, Germany

Location

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Lüneburg, 21339, Germany

Location

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Saint Ingbert-Oberwürzbach, 66386, Germany

Location

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Thessaloniki, 57010, Greece

Location

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Budapest, 1171, Hungary

Location

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Pápa, 8500, Hungary

Location

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Guadalajara Jalisco, 04460, Mexico

Location

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Mexico City, 03300, Mexico

Location

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Monterrey, 64710, Mexico

Location

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Tampico, 89000, Mexico

Location

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Bialystok, 15-404, Poland

Location

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Gdansk, 80-858, Poland

Location

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Ruda Śląska, 41-709, Poland

Location

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Wroclaw, 50-403, Poland

Location

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Carolina, 00983, Puerto Rico

Location

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Manatí, 00674, Puerto Rico

Location

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San Juan, 00917-3104, Puerto Rico

Location

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Santurce, 00909, Puerto Rico

Location

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Seoul, 139-872, South Korea

Location

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Ulsan, 682-714, South Korea

Location

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Málaga, 29006, Spain

Location

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Palma de Mallorca, 07014, Spain

Location

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Teruel, 44001, Spain

Location

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Taichung, 404, Taiwan

Location

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Taipei, 11031, Taiwan

Location

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Yong Kung City, 71004, Taiwan

Location

Related Publications (2)

  • 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

  • Pollom RK, Costigan T, Lacaya LB, Ilag LL, Hollander PA. Similar Efficacy and Safety of Basaglar(R) and Lantus(R) in Patients with Type 2 Diabetes in Age Groups (< 65 Years, >/= 65 Years): A Post Hoc Analysis from the ELEMENT-2 Study. Diabetes Ther. 2018 Apr;9(2):827-837. doi: 10.1007/s13300-018-0405-5. Epub 2018 Mar 14.

    PMID: 29542012DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

LY2963016 insulin glargineInsulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic 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 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
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

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

December 18, 2014

Results First Posted

October 9, 2014

Record last verified: 2014-12

Locations

DE(7)PL(4)KR(2)CZ(2)HU(2)ES(3)FR(2)US(28)TW(3)GR(1)ME(4)PR(4)