NCT01191268

Brief Summary

The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
884

participants targeted

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

Timeline
Completed

Started Nov 2010

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
16 countries

101 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 27, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
7 months 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 8, 2014

Completed
Last Updated

October 8, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

August 27, 2010

Results QC Date

October 3, 2014

Last Update Submit

October 3, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)

    Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, baseline metformin, and baseline HbA1c.

    Baseline, 26 weeks

Secondary Outcomes (29)

  • Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)

    Baseline, 52 weeks

  • Percentage of Participants Attaining Glycosylated Hemoglobin (HbA1c) Less Than 7% and Less Than or Equal to 6.5% at Weeks 26 and 52

    26 weeks and 52 weeks

  • Change From Baseline to 26 and 52 Weeks in the Percentage of Participants Achieving Glycosylated Hemoglobin (HbA1c) Less Than 7% Without Nocturnal or Severe Hypoglycemia

    Baseline, 26 weeks, and 52 weeks

  • Change From Baseline to 26 and 52 Weeks in Blood Glucose Values From the 8-point Self-monitored Plasma Glucose (SMPG) Profiles

    Baseline, 26 weeks, and 52 weeks

  • Change From Baseline to 26 and 52 Weeks in Fasting Serum Glucose

    Baseline, 26 weeks, and 52 weeks

  • +24 more secondary outcomes

Study Arms (3)

1.5 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Drug: LY2189265Drug: Insulin Lispro

0.75 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Drug: LY2189265Drug: Insulin Lispro

Insulin Glargine

ACTIVE COMPARATOR

Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks

Drug: Insulin GlargineDrug: Insulin Lispro

Interventions

Insulin GlargineDRUG
Insulin Glargine
LY2189265DRUG
Also known as: Dulaglutide
0.75 mg LY21892651.5 mg LY2189265
Insulin LisproDRUG
0.75 mg LY21892651.5 mg LY2189265Insulin Glargine

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
  • Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
  • Willing to inject subcutaneous medication
  • Willing to monitor blood glucose levels and adjust insulin dose
  • Willing to maintain a study diary
  • Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2)
  • Stable weight for 3 months prior to screening
  • Females of child bearing potential must test negative for pregnancy at screening and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug

You may not qualify if:

  • Type 1 Diabetes
  • Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
  • or more episodes of ketoacidosis within 6 months prior to screening
  • Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
  • Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening
  • Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
  • History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
  • Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
  • Acute or chronic hepatitis or pancreatitis
  • Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
  • Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
  • Organ transplant except cornea
  • Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
  • History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
  • Known drug or alcohol abuse
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (101)

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Concord, California, 94520, United States

Location

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La Mesa, California, 91942, United States

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Lancaster, California, 93534, United States

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New Britain, Connecticut, 06050, United States

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Hollywood, Florida, 33021, United States

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Jacksonville, Florida, 32209, United States

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West Palm Beach, Florida, 33401, United States

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Winter Haven, Florida, 33880, United States

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Honolulu, Hawaii, 96813, United States

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Indianapolis, Indiana, 46202, United States

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Topeka, Kansas, 66606, United States

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Lexington, Kentucky, 40503, United States

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Paducah, Kentucky, 42003, United States

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Metairie, Louisiana, 70006, United States

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New Orleans, Louisiana, 70121, United States

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Haverhill, Massachusetts, 01830, United States

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Springfield, Massachusetts, 01199, United States

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Waltham, Massachusetts, 02453, United States

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Worcester, Massachusetts, 01605, United States

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Minneapolis, Minnesota, 55416, United States

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Chesterfield, Missouri, 63017, United States

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Nashua, New Hampshire, 03063, United States

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Toms River, New Jersey, 08753, United States

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Albany, New York, 12206, United States

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Asheville, North Carolina, 28803, United States

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Morehead City, North Carolina, 28557, United States

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Fargo, North Dakota, 58103, United States

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Eugene, Oregon, 97401, United States

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Myrtle Beach, South Carolina, 29572, United States

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Memphis, Tennessee, 38119, United States

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Austin, Texas, 78731, United States

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Dallas, Texas, 75230, United States

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Federal Way, Washington, 98003, United States

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Renton, Washington, 98057, United States

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Vancouver, Washington, 98664, United States

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Wenatchee, Washington, 98801, United States

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Buenos Aires, C1034ACO, Argentina

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Cipolletti, 8324, Argentina

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Mendoza, M5500CCE, Argentina

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Salta, 4406, Argentina

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Keswick, South Australia, 5035, Australia

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Box Hill, Victoria, 3128, Australia

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Melbourne, Victoria, 3004, Australia

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Bonheiden, 2820, Belgium

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Brussels, 1070, Belgium

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Genk, 3600, Belgium

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Liège, 4000, Belgium

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Belém, 66073-000, Brazil

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Fortaleza, 60430-350, Brazil

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Porto Alegre, 90035-170, Brazil

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São Paulo, 04266-010, Brazil

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New Westminster, British Columbia, V3L 3W5, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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London, Ontario, N6G 4X8, Canada

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Gatineau, Quebec, J8V 2P5, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Aarhus, 8000, Denmark

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Copenhagen, 2400, Denmark

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Hillerød, Dk-3400, Denmark

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Koege, 4600, Denmark

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Kolding, 6000, Denmark

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Ampelokipoi, 11527, Greece

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Athens, 11527, Greece

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Nikaias - Piraeus, 18454, Greece

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Thessaloniki, 54639, Greece

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Békéscsaba, 5600, Hungary

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Budapest, 1115, Hungary

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Gyöngyös, 3200, Hungary

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Miskolc, 3529, Hungary

Location

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Nagykanizsa, 8800, Hungary

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Nyíregyháza, 4400, Hungary

Location

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Pápa, 8500, Hungary

Location

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Culiacán, 80020, Mexico

Location

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Guadalajara, 44650, Mexico

Location

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Mérida, 97070, Mexico

Location

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Monterrey, 64461, Mexico

Location

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Gdynia, 81-557, Poland

Location

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Lodz, 90-242, Poland

Location

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Radzymin, 05-250, Poland

Location

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Wroclaw, 50-349, Poland

Location

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Manatí, 00674, Puerto Rico

Location

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Ponce, 00728, Puerto Rico

Location

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San Juan, 00917-3104, Puerto Rico

Location

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Yabucoa, 00767, Puerto Rico

Location

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Moscow, 127486, Russia

Location

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Saint Petersburg, 191126, Russia

Location

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Samara, 443095, Russia

Location

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Barcelona, 08022, Spain

Location

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Madrid, 28046, Spain

Location

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Palma de Mallorca, 07010, Spain

Location

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Pozuelo de Alarcón, 28223, Spain

Location

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Teruel, 44002, Spain

Location

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Valencia, 46014, Spain

Location

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Karlstad, 65185, Sweden

Location

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Lund, 22185, Sweden

Location

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Stockholm, 113 61, Sweden

Location

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Kaohsiung City, 807, Taiwan

Location

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Sindian City, 23148, Taiwan

Location

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Taichung, 404, Taiwan

Location

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Taipei, 11031, Taiwan

Location

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Yongkang District, 710, Taiwan

Location

Related Publications (4)

  • Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.

    PMID: 29430801DERIVED

  • Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.

    PMID: 27161178DERIVED

  • Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.

    PMID: 26691396DERIVED

  • Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9.

    PMID: 26009229DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin GlarginedulaglutideInsulin Lispro

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine 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 27, 2010

First Posted

August 30, 2010

Study Start

November 1, 2010

Primary Completion

February 1, 2012

Study Completion

September 1, 2012

Last Updated

October 8, 2014

Results First Posted

October 8, 2014

Record last verified: 2014-10

Locations

AR(4)ME(4)PR(4)ES(6)TW(5)AU(3)US(36)CA(5)SE(3)BE(4)DK(5)BR(4)PL(4)RU(3)GR(4)HU(7)