A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)
NCT ID: NCT01126580
Last Updated: 2015-01-16
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
807 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-05-31
Study Completion Date
2012-06-30
Brief Summary
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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.
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Detailed Description
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The term rescue therapy in this trial was defined primarily as additional nontrial antidiabetic medication for the management of severe, persistent hyperglycemia or alternative antidiabetic medication following study drug discontinuation. For efficacy analyses, participants who received rescue medication were included in the analysis population, but only measurements obtained prior to taking rescue therapy were included in the efficacy analysis. For safety analyses, with the exception of hypoglycemia outcomes, all measurements including those obtained after taking rescue therapy were included in the analysis.
Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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1.5 mg LY2189265
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
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo (oral)
Intervention Type
DRUG
0.75 mg LY2189265
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
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo (oral)
Intervention Type
DRUG
Metformin
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
Group Type
ACTIVE_COMPARATOR
Metformin
Intervention Type
DRUG
Placebo (subcutaneous)
Intervention Type
DRUG
Interventions
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Metformin
Intervention Type
DRUG
LY2189265
Intervention Type
DRUG
Placebo (oral)
Intervention Type
DRUG
Placebo (subcutaneous)
Intervention Type
DRUG
Other Intervention Names
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Dulaglutide
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples.
* Have previously participated or signed an informed consent document for this same type of study and study drug.
* 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.
* Have a blood disorder that would interfere with the drawing of blood glucose measurements or lab samples.
* Have previously participated or signed an informed consent document for this same type of study and study drug.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Buena Park, California, United States
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Burbank, California, United States
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Redlands, California, United States
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San Mateo, California, United States
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Fort Lauderdale, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Gurnee, Illinois, United States
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Springfield, Illinois, United States
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Topeka, Kansas, United States
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Louisville, Kentucky, United States
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Southfield, Michigan, United States
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Nashua, New Hampshire, United States
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Rochester, New York, United States
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Raleigh, North Carolina, United States
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Eugene, Oregon, United States
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Beaver, Pennsylvania, United States
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Johnstown, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Austin, Texas, United States
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Georgetown, Texas, United States
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Richmond, Virginia, United States
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Olympia, Washington, United States
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Selah, Washington, United States
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Spokane, Washington, United States
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Buenos Aires, , Argentina
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San Isidro, , Argentina
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Fortaleza, , Brazil
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São Paulo, , Brazil
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Kelowna, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Sherbrooke, Quebec, Canada
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Dubrovnik, , Croatia
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Osijek, , Croatia
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Slavonski Brod, , Croatia
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Zagreb, , Croatia
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Beroun, , Czechia
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Nový Jičín, , Czechia
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Prague, , Czechia
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Nurmijärvi, , Finland
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Oulu, , Finland
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La Bouëxière, , France
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Mûrs-Erigné, , France
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Nantes, , France
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Vieux-Condé, , France
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Gebhardshain, , Germany
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Mainz, , Germany
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Münster, , Germany
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Neunkirchen, , Germany
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Potsdam, , Germany
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Bangalore, , India
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Chennai, , India
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Mumbai, , India
Site Status
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Nagpur, , India
Site Status
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Mexico City, , Mexico
Site Status
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Monterrey, , Mexico
Site Status
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Tampico, , Mexico
Site Status
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Lodz, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Wroclaw, , Poland
Site Status
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Carolina, , Puerto Rico
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Manatí, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Bucharest, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Galati, , Romania
Site Status
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Reşiţa, , Romania
Site Status
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Banská Bystrica, , Slovakia
Site Status
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Bratislava, , Slovakia
Site Status
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Trebišov, , Slovakia
Site Status
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Halfway House, , South Africa
Site Status
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Kempton Park, , South Africa
Site Status
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Somerset West, , South Africa
Site Status
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Bucheon-si, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Suwon, , South Korea
Site Status
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Begonte, , Spain
Site Status
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Granada, , Spain
Site Status
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Seville, , Spain
Site Status
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Penzance, Cornwall, United Kingdom
Site Status
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Durham, County Durham, United Kingdom
Site Status
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London, Greater London, United Kingdom
Site Status
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Cleveleys, Lancashire, United Kingdom
Site Status
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Crawley, , United Kingdom
Site Status
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Nottingham, , United Kingdom
Site Status
Countries
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United States
Argentina
Brazil
Canada
Croatia
Czechia
Finland
France
Germany
India
Mexico
Poland
Puerto Rico
Romania
Slovakia
South Africa
South Korea
Spain
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H9X-MC-GBDC
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2010/091/003036
Identifier Type: REGISTRY
Identifier Source: secondary_id
11375
Identifier Type: -
Identifier Source: org_study_id
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