NCT01126580

Brief Summary

The purpose of this study is to determine if LY2189265 is safe and effective in reducing glycosylated hemoglobin (HbA1c) as compared to metformin in participants with Type 2 Diabetes.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
807

participants targeted

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

Timeline
Completed

Started May 2010

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
19 countries

91 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

May 1, 2010

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 16, 2015

Completed
Last Updated

January 16, 2015

Status Verified

January 1, 2015

Enrollment Period

1.5 years

First QC Date

May 18, 2010

Results QC Date

October 3, 2014

Last Update Submit

January 15, 2015

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 were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group (previous oral antihyperglycemic medication \[OAM\] versus no previous OAM) as fixed effects and baseline HbA1c as a covariate.

    Baseline, 26 weeks

Secondary Outcomes (29)

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

    Baseline, 52 weeks

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

    26 weeks and 52 weeks

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

    Baseline, 26 weeks, and 52 weeks

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

    Baseline, 26 weeks, and 52 weeks

  • Change From Baseline to 26 and 52 Weeks in Body Weight

    Baseline, 26 weeks, and 52 weeks

  • +24 more secondary outcomes

Study Arms (3)

1.5 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks Placebo: 1 tablet per day, orally, for Week 1; 2 tablets per day, orally, for Week 2; 3 tablets per day, orally, for Week 3; 4 or at least 3 tablets, orally, for Weeks 4 through Week 52

Drug: LY2189265Drug: Placebo (oral)

0.75 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks Placebo: 1 tablet per day, orally, for Week 1; 2 tablets per day, orally, for Week 2; 3 tablets per day, orally, for Week 3; 4 or at least 3 tablets, orally, for Weeks 4 through Week 52

Drug: LY2189265Drug: Placebo (oral)

Metformin

ACTIVE COMPARATOR

Metformin: 500 milligrams per day (mg/day), orally, for Week 1; 1000 mg/day, orally, for Week 2; 1500 mg/day, orally, for Week 3; 2000 or at least 1500 mg/day, orally, for Weeks 4 through Week 52 Placebo: subcutaneously (SC), once weekly for 52 weeks

Drug: MetforminDrug: Placebo (subcutaneous)

Interventions

MetforminDRUG
Metformin
LY2189265DRUG
Also known as: Dulaglutide
0.75 mg LY21892651.5 mg LY2189265
Placebo (oral)DRUG
0.75 mg LY21892651.5 mg LY2189265
Placebo (subcutaneous)DRUG
Metformin

Eligibility Criteria

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

You may qualify if:

  • Have type 2 diabetes for greater than or equal to 3 months and less than or equal to 5 years based on the disease diagnostic criteria (refer to the World Health Organization's \[WHO\] Classification of Diabetes).
  • Are treatment-naïve, not optimally controlled with diet and exercise alone, or are taking 1 oral antihyperglycemic medication (OAM) as monotherapy (excluding thiazolidinediones). For those on 1 OAM, the dose must be less than or equal to 50% the maximum authorized per local label.
  • Are able and willing to tolerate a minimum dose of 1500 milligrams per day (mg/day) or up to 2000 mg/day of metformin.
  • Have glycosylated hemoglobin (HbA1c) greater than or equal to 6.5% to less than or equal to 9.5%.
  • Females of childbearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must: a) test negative for pregnancy at screening based on a serum pregnancy test, and b) agree to use a reliable method of birth control during the study and for 1 month following the last dose of study drug; or c) not be breastfeeding.
  • Have a stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening.
  • Have a body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2), inclusive.
  • Are well-motivated, capable, and willing to: a) perform self-monitored blood glucose (SMBG) testing; b) learn how to self-inject treatment (LY2189265 or placebo) and c) maintain a study diary.

You may not qualify if:

  • Have type 1 diabetes mellitus.
  • Are being or have been treated with any of the following medications: a) chronically treated with insulin for the treatment of diabetes in the past; however, a short-term use of insulin more than 3 months prior to screening is allowable, b) glucagon-like peptide 1 (GLP-1) analogs within 3 months prior to this screening, c) drugs to cause weight loss within 3 months prior to screening, d) thiazolidinediones (TZDs) within 3 months prior to screening, e) chronically treated (greater than or equal to 14 days) with an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening, or f) illegal drugs.
  • Have had 1 or more cases of uncontrolled diabetes that required hospitalization in the 6 months prior to screening.
  • Have stomach problems, have chronically taken medication to increase movement in the digestive tract or slow down the emptying of the digestive tract, or have had gastric bypass (bariatric) surgery.
  • Have had problems with the heart or brain in the past 2 months prior to screening, such as a heart attack, chest pain, heart failure, heart bypass operation, angioplasty or stent insertion, a heart rhythm problem, or a stroke.
  • Have a serum creatinine result which shows a greater than or equal to 1.5 milligrams per deciliter (mg/dL) for men or greater than or equal to 1.4 mg/dL for women.
  • Have a problem with the liver or pancreas.
  • Have a creatinine clearance result which shows less than 60 milliliters per minute (mL/min), evidence of a significant active, uncontrolled endocrine (hormone), or active autoimmune abnormality.
  • Have a serum calcitonin test which shows greater than or equal to 20 picograms per milliliter (pcg/mL) at the time of screening.
  • Have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
  • Have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.
  • Have had an organ transplant except for corneal transplant.
  • Have received treatment within the last 30 days with a drug which has not been regulatory approved.
  • Have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed within 30 days prior to screening.
  • Have any condition that is a contraindication to or would interfere with medications provided for this study to treat diabetes.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (91)

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Huntsville, Alabama, 35801, United States

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Phoenix, Arizona, 85018, United States

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Buena Park, California, 90620, United States

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Burbank, California, 91505, United States

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Redlands, California, 92374, United States

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San Mateo, California, 94401, United States

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Fort Lauderdale, Florida, 33316, United States

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Orlando, Florida, 32822, United States

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Atlanta, Georgia, 30303, United States

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Idaho Falls, Idaho, 83404, United States

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Gurnee, Illinois, 60031, United States

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Springfield, Illinois, 62704, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40217, United States

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Southfield, Michigan, 48075, United States

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Nashua, New Hampshire, 03063, United States

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Rochester, New York, 14609, United States

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Raleigh, North Carolina, 27609, United States

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Eugene, Oregon, 97404, United States

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Beaver, Pennsylvania, 15009, United States

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Johnstown, Pennsylvania, 15905, United States

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Levittown, Pennsylvania, 19056, United States

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Austin, Texas, 78749, United States

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Georgetown, Texas, 78626, United States

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Richmond, Virginia, 23233, United States

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Olympia, Washington, 98502, United States

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Selah, Washington, 98942, United States

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Spokane, Washington, 99208, United States

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Buenos Aires, C1188AAF, Argentina

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San Isidro, B1642DCD, Argentina

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Fortaleza, 60430-350, Brazil

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São Paulo, 04020-041, Brazil

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Kelowna, British Columbia, V1Y 1Z9, Canada

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Vancouver, British Columbia, V5Z 3J5, Canada

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Winnipeg, Manitoba, R2V 4W3, Canada

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Halifax, Nova Scotia, B3H 1V7, Canada

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Toronto, Ontario, M9W 4L6, Canada

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Sherbrooke, Quebec, J1H1Z1, Canada

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Dubrovnik, 20000, Croatia

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Osijek, 31000, Croatia

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Slavonski Brod, 35000, Croatia

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Zagreb, 10000, Croatia

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Beroun, 26601, Czechia

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Nový Jičín, 74101, Czechia

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Prague, 149 00, Czechia

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Nurmijärvi, 01900, Finland

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Oulu, 90100, Finland

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La Bouëxière, 35340, France

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Mûrs-Erigné, 49610, France

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Nantes, 44300, France

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Vieux-Condé, 59690, France

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Gebhardshain, 57580, Germany

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Mainz, 55116, Germany

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Münster, 48145, Germany

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Neunkirchen, 66539, Germany

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Potsdam, 14469, Germany

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Bangalore, 560003, India

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Chennai, 600029, India

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Mumbai, 400053, India

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Nagpur, 440020, India

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Mexico City, 6700, Mexico

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Monterrey, 64461, Mexico

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Tampico, 89000, Mexico

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Lodz, 90-242, Poland

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Warsaw, 02-091, Poland

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Wroclaw, 50-349, Poland

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Carolina, 00983, Puerto Rico

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Manatí, 00674, Puerto Rico

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San Juan, 00987, Puerto Rico

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Bucharest, 020359, Romania

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Cluj-Napoca, 400006, Romania

Location

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Galati, 800587, Romania

Location

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Reşiţa, 320076, Romania

Location

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Banská Bystrica, 97405, Slovakia

Location

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Bratislava, 821 03, Slovakia

Location

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Trebišov, 07501, Slovakia

Location

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Halfway House, 1685, South Africa

Location

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Kempton Park, 1619, South Africa

Location

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Somerset West, 7130, South Africa

Location

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Bucheon-si, 420-717, South Korea

Location

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Seoul, 136 705, South Korea

Location

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Suwon, 442-723, South Korea

Location

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Begonte, 27373, Spain

Location

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Granada, 18012, Spain

Location

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Seville, 41003, Spain

Location

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Penzance, Cornwall, TR19 7HX, United Kingdom

Location

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Durham, County Durham, DH1 2QW, United Kingdom

Location

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London, Greater London, W9 1SP, United Kingdom

Location

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Cleveleys, Lancashire, FY5 3LF, United Kingdom

Location

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Crawley, RH10 7DX, United Kingdom

Location

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Nottingham, NG3 7DQ, United Kingdom

Location

Related Publications (4)

  • Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

    PMID: 32501595DERIVED

  • 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

  • Umpierrez G, Tofe Povedano S, Perez Manghi F, Shurzinske L, Pechtner V. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). Diabetes Care. 2014 Aug;37(8):2168-76. doi: 10.2337/dc13-2759. Epub 2014 May 19.

    PMID: 24842985DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetformindulaglutideInjections, Subcutaneous

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsInjectionsDrug Administration RoutesDrug TherapyTherapeutics

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 19, 2010

Study Start

May 1, 2010

Primary Completion

November 1, 2011

Study Completion

June 1, 2012

Last Updated

January 16, 2015

Results First Posted

January 16, 2015

Record last verified: 2015-01

Locations

ES(3)ZA(3)CA(6)SL(3)DE(5)RO(4)BR(2)GB(6)AR(2)US(28)FR(4)ME(3)CZ(3)PL(3)KR(3)CR(4)IN(4)FI(2)PR(3)