Clinical trial NCT01126580: A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)
Official title: The Impact of LY2189265 Versus Metformin on Glycemic Control in Early Type 2 Diabetes Mellitus (AWARD-3: Assessment of Weekly AdministRation of LY2189265 in Diabetes-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 807
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 26 weeks
Secondary outcomes:
measure: Change From Baseline to 52-week Endpoint in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, 52 weeks
measure: 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
timeFrame: 26 weeks and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Fasting Blood Glucose
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Daily Mean Blood Glucose Values From the 8-point Self-monitored Blood Glucose (SMBG) Profiles
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Body Weight
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version
timeFrame: 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks
timeFrame: 26 weeks and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Pulse Rate
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Blood Pressure
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Change From Baseline to 26 and 52 Weeks in Serum Calcitonin
timeFrame: Baseline, 26 weeks, and 52 weeks
measure: Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies
timeFrame: Baseline through 52 weeks
measure: Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks
timeFrame: Baseline through 26 weeks and 52 weeks
measure: Rate of Self-reported Hypoglycemic Events at 52 Weeks
timeFrame: Baseline through 52 weeks
measure: Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up
timeFrame: Baseline through 52 weeks plus 30-day follow up
measure: Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up
timeFrame: Baseline through 52 weeks plus 30-day follow up
measure: Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)
timeFrame: 4 weeks, 13 weeks, 26 weeks, and 52 weeks
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Alabama
city: Phoenix
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
city: Buena Park
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Burbank
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Redlands
country: United States
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state: California
city: San Mateo
country: United States
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state: California
city: Fort Lauderdale
country: United States
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state: Florida
city: Orlando
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Idaho Falls
country: United States
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state: Idaho
city: Gurnee
country: United States
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state: Illinois
city: Springfield
country: United States
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state: Illinois
city: Topeka
country: United States
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state: Kansas
city: Louisville
country: United States
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state: Kentucky
city: Southfield
country: United States
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state: Michigan
city: Nashua
country: United States
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state: New Hampshire
city: Rochester
country: United States
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state: New York
city: Raleigh
country: United States
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state: North Carolina
city: Eugene
country: United States
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state: Oregon
city: Beaver
country: United States
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state: Pennsylvania
city: Johnstown
country: United States
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state: Pennsylvania
city: Levittown
country: United States
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state: Pennsylvania
city: Austin
country: United States
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state: Texas
city: Georgetown
country: United States
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state: Texas
city: Richmond
country: United States
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state: Virginia
city: Olympia
country: United States
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state: Washington
city: Selah
country: United States
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state: Washington
city: Spokane
country: United States
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state: Washington
city: Buenos Aires
country: Argentina
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city: San Isidro
country: Argentina
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city: Fortaleza
country: Brazil
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city: São Paulo
country: Brazil
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city: Kelowna
country: Canada
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state: British Columbia
city: Vancouver
country: Canada
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state: British Columbia
city: Winnipeg
country: Canada
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state: Manitoba
city: Halifax
country: Canada
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state: Nova Scotia
city: Toronto
country: Canada
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state: Ontario
city: Sherbrooke
country: Canada
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state: Quebec
city: Dubrovnik
country: Croatia
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city: Osijek
country: Croatia
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city: Slavonski Brod
country: Croatia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Zagreb
country: Croatia
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city: Beroun
country: Czech Republic
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city: Novy Jicin
country: Czech Republic
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city: Prague
country: Czech Republic
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city: Nurmijarvi
country: Finland
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city: Oulu
country: Finland
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city: La Bouexiere
country: France
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city: Murs Erigne
country: France
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city: Nantes
country: France
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city: Vieux Conde
country: France
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city: Gebhardshain
country: Germany
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city: Mainz
country: Germany
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city: Münster
country: Germany
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city: Neunkirchen
country: Germany
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city: Potsdam
country: Germany
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city: Bangalore
country: India
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city: Chennai
country: India
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city: Mumbai
country: India
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city: Nagpur
country: India
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city: Bucheon
country: Korea, Republic of
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city: Seoul
country: Korea, Republic of
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city: Suwon-City
country: Korea, Republic of
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city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
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city: Tampico
country: Mexico
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city: Lodz
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Warsaw
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wroclaw
country: Poland
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Carolina
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Manati
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: San Juan
country: Puerto Rico
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bucharest
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Cluj-Napoca
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Galati
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Resita
country: Romania
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Banska Bystrica
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Bratislava
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Trebisov
country: Slovakia
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Halfway House
country: South Africa
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Kempton Park
country: South Africa
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Somerset West
country: South Africa
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Begonte
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Granada
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Seville
country: Spain
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Penzance
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Cornwall
city: Durham
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: County Durham
city: London
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Greater London
city: Cleveleys
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Lancashire
city: Crawley
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nottingham
country: United Kingdom
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.