AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT01126580

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

A Phase 3 study testing Metformin and LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 91 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Metformin and LY2189265
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
807 participants
Where
91 sitesin 19 countries
Study dates
May 2010to Jun 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

91 sites in 19 countries.

91 sites in 19 countries

United States28 sites

  • 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.

    Atlanta, Georgia, 30303

  • 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.

    Austin, Texas, 78749

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    Beaver, Pennsylvania, 15009

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    Buena Park, California, 90620

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    Burbank, California, 91505

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    Eugene, Oregon, 97404

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    Fort Lauderdale, Florida, 33316

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    Georgetown, Texas, 78626

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    Gurnee, Illinois, 60031

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    Huntsville, Alabama, 35801

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    Idaho Falls, Idaho, 83404

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    Johnstown, Pennsylvania, 15905

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    Levittown, Pennsylvania, 19056

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    Louisville, Kentucky, 40217

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    Nashua, New Hampshire, 03063

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    Olympia, Washington, 98502

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    Orlando, Florida, 32822

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    Phoenix, Arizona, 85018

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    Raleigh, North Carolina, 27609

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    Redlands, California, 92374

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    Richmond, Virginia, 23233

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    Rochester, New York, 14609

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    San Mateo, California, 94401

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    Selah, Washington, 98942

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    Southfield, Michigan, 48075

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    Spokane, Washington, 99208

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    Springfield, Illinois, 62704

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    Topeka, Kansas, 66606

Other trials in United States

Canada6 sites

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    Halifax, Nova Scotia, B3H 1V7

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    Kelowna, British Columbia, V1Y 1Z9

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    Sherbrooke, Quebec, J1H1Z1

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    Toronto, Ontario, M9W 4L6

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    Vancouver, British Columbia, V5Z 3J5

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    Winnipeg, Manitoba, R2V 4W3

Other trials in Canada

United Kingdom6 sites

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    Cleveleys, Lancashire, FY5 3LF

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    Crawley, RH10 7DX

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    Durham, County Durham, DH1 2QW

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    London, Greater London, W9 1SP

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    Nottingham, NG3 7DQ

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    Penzance, Cornwall, TR19 7HX

Other trials in United Kingdom

Germany5 sites

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    Gebhardshain, 57580

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    Mainz, 55116

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    Münster, 48145

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    Neunkirchen, 66539

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    Potsdam, 14469

Other trials in Germany

Croatia4 sites

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    Dubrovnik, 20000

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    Osijek, 31000

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    Slavonski Brod, 35000

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    Zagreb, 10000

Other trials in Croatia

France4 sites

  • 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.

    La Bouëxière, 35340

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    Mûrs-Erigné, 49610

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    Nantes, 44300

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    Vieux-Condé, 59690

Other trials in France

India4 sites

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    Bangalore, 560003

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    Chennai, 600029

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    Mumbai, 400053

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    Nagpur, 440020

Other trials in India

Romania4 sites

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    Bucharest, 020359

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    Cluj-Napoca, 400006

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    Galati, 800587

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    Reşiţa, 320076

Other trials in Romania

Czechia3 sites

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    Beroun, 26601

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    Nový Jičín, 74101

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    Prague, 149 00

Other trials in Czechia

Mexico3 sites

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    Mexico City, 6700

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    Monterrey, 64461

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    Tampico, 89000

Other trials in Mexico

Poland3 sites

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    Lodz, 90-242

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    Warsaw, 02-091

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    Wroclaw, 50-349

Other trials in Poland

Puerto Rico3 sites

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    Carolina, 00983

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    Manati, 00674

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    San Juan, 00987

Other trials in Puerto Rico

Slovakia3 sites

  • 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.

    Banská Bystrica, 97405

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    Bratislava, 821 03

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    Trebišov, 07501

Other trials in Slovakia

South Africa3 sites

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    Halfway House, 1685

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    Kempton Park, 1619

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    Somerset West, 7130

Other trials in South Africa

South Korea3 sites

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    Bucheon-si, 420-717

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    Seoul, 136 705

  • 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.

    Suwon, 442-723

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Spain3 sites

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    Begonte, 27373

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    Granada, 18012

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    Seville, 41003

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Argentina2 sites

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    Buenos Aires, C1188AAF

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    San Isidro, B1642DCD

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Brazil2 sites

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    Fortaleza, 60430-350

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    São Paulo, 04020-041

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Finland2 sites

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    Nurmijärvi, 01900

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    Oulu, 90100

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About this study

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)

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.

Read the 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.

Being tested
Metformin, LY2189265, Placebo (oral), Placebo (subcutaneous)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MetforminDrug

  • LY2189265Drug

    Also called Dulaglutide

  • Placebo (oral)Drug

  • Placebo (subcutaneous)Drug

Study groups in NCT01126580
Study groupRoleWhat they receive
1.5 mg LY2189265ExperimentalLY2189265 (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
Receives: Drug: LY2189265; Drug: Placebo (oral)
0.75 mg LY2189265ExperimentalLY2189265 (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
Receives: Drug: LY2189265; Drug: Placebo (oral)
MetforminActive comparatorMetformin: 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
Receives: Drug: Metformin; Drug: Placebo (subcutaneous)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, 26 weeks

Secondary outcomes (29)

  1. Change From Baseline to 52-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.

    Measured: Baseline, 52 weeks

  2. 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

    The percentage of participants achieving HbA1c level less than 7.0% and less than or equal to 6.5% was analyzed with a logistic regression model with baseline, prior medication group, and treatment as factors included in the model.

    Measured: 26 weeks and 52 weeks

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

    Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline fasting blood glucose as a covariate, and participant as a random effect.

    Measured: Baseline, 26 weeks, and 52 weeks

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

    The SMBG data were collected at the following 8 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening; 2 hours post-evening meal; bedtime; and 3AM or 5 hours after bedtime. Least Squares (LS) means of the mean of the 8 time points (daily mean) were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline daily mean as a covariate.

    Measured: Baseline, 26 weeks, and 52 weeks

  5. Change From Baseline to 26 and 52 Weeks in Body Weight

    Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline body weight as a covariate.

    Measured: Baseline, 26 weeks, and 52 weeks

  6. Change From Baseline to 26 and 52 Weeks in Body Mass Index (BMI)

    Body mass index is an estimate of body fat based on body weight divided by height squared. Least Squares (LS) means were calculated using analysis of covariance (ANCOVA) with country, treatment, and prior medication group as fixed effects and baseline BMI as a covariate.

    Measured: Baseline, 26 weeks, and 52 weeks

  7. Change From Baseline to 26 and 52 Weeks in Homeostasis Model Assessment of Beta-cell Function

    The homeostatic model assessment (HOMA) quantifies insulin resistance and beta-cell function. HOMA2-B is a computer model that uses fasting plasma insulin and glucose concentrations to estimate steady-state beta cell function (%B) as a percentage of a normal reference population (normal young adults). HOMA2-S is a computer model that uses fasting plasma insulin and glucose concentrations to estimate insulin sensitivity (%S) as percentages of a normal reference population (normal young adults). The normal reference populations were set at 100%. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline HOMA2 as a covariate, and participant as a random effect.

    Measured: Baseline, 26 weeks, and 52 weeks

  8. Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) Score

    The Impact of Weight on Activities of Daily Living (renamed the Ability to Perform Physical Activities of Daily Living [APPADL]) questionnaire contains 7 items that assess how difficult it is for participants to engage in certain activities considered to be integral to normal daily life, such as walking, standing and climbing stairs. Items are scored on a 5-point numeric rating scale where 5 = "not at all difficult" and 1 = "unable to do". The individual scores from all 7 items are summed and a single total score is calculated and may range between 7 and 35. A higher score indicates better ability to perform activities of daily living. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

    Measured: Baseline, 26 weeks, and 52 weeks

  9. Change From Baseline to 26 and 52 Weeks in the Impact of Weight on Self-Perception (IW-SP) Score

    The Impact of Weight on Self-Perception (IW-SP) questionnaire contains 3 items that assess how often the participants' body weight affects how happy they are with their appearance and how often they feel self-conscious when out in public. Items are scored on a 5-point numeric rating scale where 5 = never and 1 = always. A single total score is calculated by summing the scores for all 3 items. Total score ranges between 3 and 15, where a higher score is indicative of better self-perception. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

    Measured: Baseline, 26 weeks, and 52 weeks

  10. Change From Baseline to 26 and 52 Weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Status Version

    The Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) is used to assess participant treatment satisfaction at each study visit. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. Scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from 0 (very dissatisfied) to 36 (very satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

    Measured: Baseline, 26 weeks, and 52 weeks

  11. Diabetes Treatment Satisfaction Questionnaire (DTSQ) Score, Change Version

    The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) score is used to assess relative change in participant satisfaction from baseline. The questionnaire consists of 8 items, 6 of which (1 and 4 through 8) assess treatment satisfaction. Each item is rated on a 7-point Likert scale. The scores from the 6 treatment satisfaction items are summed to a Total Treatment Satisfaction Score, which ranges from -18 (much less satisfied) to +18 (much more satisfied). Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

    Measured: 52 weeks

  12. Change From Baseline to 26 and 52 Weeks in the Diabetes Symptoms Checklist Participant-reported Outcome (DSC-r) Score

    The Diabetes Symptoms Checklist-revised (DSC-r) was designed to assess the presence and perceived burden of diabetes-related symptoms. Respondents were to consider troublesomeness of 34 symptoms on a 5-point scale ranging from 5="extremely" to 1="not at all." For symptoms/side-effects not experienced, the item was scored as 0. Symptoms were grouped into the following subscales: psychology-fatigue, psychology-cognitive, neurology-pain, neurology-sensory, cardiology, ophthalmology, hypoglycemia, and hyperglycemia. Subscale scores were calculated as the sum of the given subscale divided by the total number of items in the scale. Total score was computed from the sum of the 8 subscales and ranged from 0 to 40. Higher scores indicate greater symptom burden. Least Squares (LS) means of change from baseline were calculated using analysis of covariance (ANCOVA) adjusted by treatment, country, prior medication group, gender, and baseline score.

    Measured: Baseline, 26 weeks, and 52 weeks

  13. Number of Participants With Treatment Emergent Adverse Events at 26 and 52 Weeks

    A treatment-emergent adverse event (TEAE) was defined as an event that first occurs or worsens (increases in severity) after baseline regardless of causality or severity. The number of participants with one or more TEAE is summarized cumulatively at 26 and 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: 26 weeks and 52 weeks

  14. Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Fridericia Corrected QT (QTcF) Interval and PR Interval

    The QT interval is a measure of the time between the start of the Q wave and the end of the T wave and was calculated from electrocardiogram (ECG) data using Fridericia's formula: QTc = QT/RR^0.33. Corrected QT (QTc) is the QT interval corrected for heart rate and RR, which is the interval between two R waves. PR is the interval between the P wave and the QRS complex. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.

    Measured: Baseline, 26 weeks, and 52 weeks

  15. Change From Baseline to 26 and 52 Weeks in Electrocardiogram Parameters, Heart Rate

    Electrocardiogram (ECG) heart rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects and baseline interval as a covariate.

    Measured: Baseline, 26 weeks, and 52 weeks

  16. Change From Baseline to 26 and 52 Weeks in Pulse Rate

    Sitting pulse rate was measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.

    Measured: Baseline, 26 weeks, and 52 weeks

  17. Change From Baseline to 26 and 52 Weeks in Blood Pressure

    Sitting systolic blood pressure (SBP) and sitting diastolic blood pressure (DBP) were measured. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, country, prior medication group, visit, and treatment-by-visit interaction as fixed effects, baseline interval as a covariate, and participant as a random effect.

    Measured: Baseline, 26 weeks, and 52 weeks

  18. Percent Change From Baseline to 26 and 52 Weeks in Total Cholesterol

    Percent changes in total cholesterol were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

    Measured: Baseline, 26 weeks, and 52 weeks

  19. Percentage Change From Baseline to 26 and 52 Weeks in High Density Lipoprotein Cholesterol (HDL-C)

    Percentage changes in HDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

    Measured: Baseline, 26 weeks, and 52 weeks

  20. Percentage Change From Baseline to 26 and 52 Weeks in Low Density Lipoprotein Cholesterol (LDL-C)

    Percentage changes in LDL-C were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

    Measured: Baseline, 26 weeks, and 52 weeks

  21. Percentage Change From Baseline to 26 and 52 Weeks in Triglycerides

    Percentage changes in triglycerides were assessed using analysis of variance (ANOVA) on the rank-transformed data with only treatment included in the model.

    Measured: Baseline, 26 weeks, and 52 weeks

  22. Change From Baseline to 26 and 52 Weeks in Pancreatic Enzymes

    Amylase (total and pancreas-derived [PD]) and lipase concentrations were measured.

    Measured: Baseline, 26 weeks, and 52 weeks

  23. Change From Baseline to 26 and 52 Weeks in Serum Calcitonin

    Measured: Baseline, 26 weeks, and 52 weeks

  24. Number of Participants With Treatment Emergent Anti-LY2189265 Antibodies

    A participant was considered to have treatment emergent LY2189265 anti-drug antibodies (ADA) if the participant had at least one titer that was treatment-emergent relative to baseline, defined as a 4-fold or greater increase in titer from baseline measurement. The total number of treatment emergent ADA was not analyzed at 26 weeks.

    Measured: Baseline through 52 weeks

  25. Number of Self-reported Hypoglycemic Events at 26 and 52 Weeks

    Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Baseline through 26 weeks and 52 weeks

  26. Rate of Self-reported Hypoglycemic Events at 52 Weeks

    Hypoglycemic events were classified as severe (defined as episodes requiring the assistance of another person to actively administer resuscitative actions), documented symptomatic (defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a plasma glucose level of less than or equal to 70 milligrams per deciliter [mg/dL]), or asymptomatic (defined as events not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of less than or equal to 70 mg/dL). The 1-year adjusted rate of hypoglycemic events is summarized cumulatively at 52 weeks. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Baseline through 52 weeks

  27. Number of Participants With Adjudicated Pancreatitis at 52 Weeks Plus 30-day Follow up

    The number of participants with pancreatitis confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Baseline through 52 weeks plus 30-day follow up

  28. Number of Participants With Adjudicated Cardiovascular Events at 52 Weeks Plus 30-day Follow up

    Information on cardiovascular (CV) risk factors was collected at baseline. Data on any new CV event was prospectively collected using a CV event electronic case report form. Deaths and nonfatal cardiovascular adverse events (AEs) were adjudicated by an external committee of physicians with cardiology expertise. Nonfatal cardiovascular AEs to be adjudicated included myocardial infarction, hospitalization for unstable angina, hospitalization for heart failure, coronary interventions, and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack. The number of participants with CV events confirmed by adjudication is summarized cumulatively at 52 weeks plus 30-day follow up. Serious and all other non-serious adverse events regardless of causality are summarized in the Reported Adverse Events module.

    Measured: Baseline through 52 weeks plus 30-day follow up

  29. Measurement of LY2189265 Drug Concentration for Pharmacokinetics: Area Under the Concentration Curve (AUC)

    Evaluable pharmacokinetic concentrations from the 4-week, 13-week, 26-week, and 52-week timepoints were combined and utilized in a population approach to determine the population mean estimate and standard deviation at steady-state.

    Measured: 4 weeks, 13 weeks, 26 weeks, and 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionNov 2011
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
807 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126580
Sponsor's protocol ID
11375
Other IDs
H9X-MC-GBDC, CTRI/2010/091/003036
Status last verified
Jan 2015
First submitted
18 May 2010
Last updated
16 Jan 2015
Data monitoring committee
No

Publications

  • 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.

    PubMed 32501595

  • 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.

    PubMed 27161178

  • 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.

    PubMed 26691396

  • 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.

    PubMed 24842985

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Metformin and LY2189265 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 91 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 91 sites in United States, Canada, United Kingdom, Germany, Croatia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline to 26-week Endpoint in Glycosylated Hemoglobin (HbA1c) (time frame: Baseline, 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01126580, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2015.

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