Trial record 47 of 108 for:    johnstown

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01126580
First received: May 18, 2010
Last updated: July 19, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to determine if LY2189265 is as safe and effective in reducing hemoglobin A1c (HbA1c) as compared to metformin in patients with Type 2 Diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Metformin
Drug: LY2189265
Drug: Placebo (oral)
Drug: Placebo (subcutaneous)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change in HbA1c from baseline to 26 weeks endpoint (1.5mg LY2189265 compared to metformin) [ Time Frame: Baseline, 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving an HbA1c of less than 7% and less than or equal to 6.5% at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks for blood glucose values from the 8-point self-monitored blood glucose (SMBG) profiles [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks in Homeostasis Model Assessment of beta-cell function [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks in the Impact of Weight on Activities of Daily Living (IW-ADL) score [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks in the Impact of Weight on Self-Perception (IW-SP) score [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) score [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks in the Diabetes Symptoms Checklist patient-reported outcome (DSC-r) score [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Anti-LY2189265 antibodies [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks on electrocardiogram parameters [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks on pulse rate [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks on blood pressure [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of self-reported hypoglycemic events at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks on cholesterol [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Number of Treatment Emergent Adverse events at 26 and 52 weeks [ Time Frame: 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks in body weight [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks in pancreatic enzymes [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks in serum calcitonin [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics - LY2189265 concentration [ Time Frame: 26 weeks and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26 and 52 weeks in fasting blood glucose [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, 52 weeks endpoint in HbA1c [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks on body mass index (BMI) [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline to 26, and 52 weeks on HDL [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks on LDL [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 26, and 52 weeks on triglycerides [ Time Frame: Baseline, 26 weeks, 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 753
Study Start Date: May 2010
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
Patient will take at least 1500 mg/day or up to 2000 mg/day along with a weekly injection of placebo
Drug: Metformin
Administered orally, twice daily for 52 weeks
Drug: Placebo (subcutaneous)
Administered as subcutaneous injection, once weekly for 52 weeks
Experimental: 1.5 mg LY2189265
Patient will inject once weekly along with placebo tablets taken daily
Drug: LY2189265
Administered as subcutaneous injection, once weekly for 52 weeks
Other Name: Dulaglutide
Drug: Placebo (oral)
Administered orally, twice daily for 52 weeks
Experimental: 0.75 mg LY2189265
Patient will inject once weekly along with placebo tablets taken daily
Drug: LY2189265
Administered as subcutaneous injection, once weekly for 52 weeks
Other Name: Dulaglutide
Drug: Placebo (oral)
Administered orally, twice daily for 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  • Are able and willing to tolerate a minimum dose of 1500 mg/day or up to 2000 mg/day of metformin.
  • Have 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 kg/m2, inclusive.
  • Are well-motivated, capable, and willing to: a)perform SMBG testing; b)learn how to self-inject treatment (LY2189265 or placebo)and c)maintain a study diary.

Exclusion Criteria:

  • You have type 1 diabetes mellitus
  • You 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 more than 3 months prior to screening is allowable, b)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) an oral glucocorticoid or have received this type of therapy within 4 weeks prior to screening,or f)illegal drugs.
  • You have had 1 or more cases of uncontrolled diabetes which required hospitalization in the 6 months prior to screening,
  • You have a problem with your stomach or have chronically taken medication to increase movement in your digestive tract or slow down the emptying of your digestive tract or you have had gastric bypass (bariatric) surgery.
  • You have had problems with your 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.
  • You have a serum creatinine result which shows a greater than or equal to 1.5 mg/dL for men or greater than or equal to 1.4 mg/dL for women.
  • You have a problem with your liver or pancreas.
  • You have creatinine clearance result which shows less than 60 mL/minute, evidence of a significant active, uncontrolled endocrine (hormone) or active autoimmune abnormality.
  • You have a serum calcitonin test and it shows a greater than or equal to 20 pcg/mL at the time of screening.
  • You have or have a family history of medullary C-cell hyperplasia or endocrine neoplasia type 2A or type 2B.
  • You have cancer (except for skin cancer) or have been in remission from cancer for less than 5 years.
  • You have had an organ transplant except for corneal transplant.
  • You have received treatment within the last 30 days with a drug which has not been regulatory approved.
  • You have participated in a medical, surgical, or pharmaceutical study where these types of procedures were performed on you within 30 days prior to screening.
  • You have any condition that is a contraindication to or would interfere with medications provided for this study to treat your diabetes.
  • You have a blood disorder that would interfere with us drawing blood glucose measurement or lab samples.
  • You have previously participated or signed an informed consent document for this same type of study and study drug.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126580

  Hide Study Locations
Locations
United States, Alabama
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Huntsville, Alabama, United States, 35801
United States, Arizona
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Phoenix, Arizona, United States, 85018
United States, California
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Buena Park, California, United States, 90620
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Redlands, California, United States, 92374
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San Mateo, California, United States, 94401
United States, Florida
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Orlando, Florida, United States, 32822
United States, Georgia
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United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Gurnee, Illinois, United States, 60031
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Springfield, Illinois, United States, 62704
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Louisville, Kentucky, United States, 40217
United States, Michigan
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Southfield, Michigan, United States, 48075
United States, New Hampshire
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United States, New York
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United States, North Carolina
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United States, Oregon
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United States, Pennsylvania
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Levittown, Pennsylvania, United States, 19056
United States, Texas
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Georgetown, Texas, United States, 78626
United States, Virginia
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Richmond, Virginia, United States, 23233
United States, Washington
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Olympia, Washington, United States, 98502
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Spokane, Washington, United States, 99208
Argentina
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Buenos Aires, Argentina, C1188AAF
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San Isidro, Argentina, B1642DCD
Brazil
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Fortaleza, Brazil, 60430-350
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São Paulo, Brazil, 04020-041
Canada, British Columbia
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Kelowna, British Columbia, Canada, V1Y 1Z9
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Vancouver, British Columbia, Canada, V5Z 3J5
Canada, Manitoba
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Canada, Nova Scotia
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Canada, Ontario
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Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
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Sherbrooke, Quebec, Canada, J1H1Z1
Croatia
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Dubrovnik, Croatia, 20000
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Osijek, Croatia, 31000
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Slavonski Brod, Croatia, 35000
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Zagreb, Croatia, 10000
Czech Republic
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Beroun, Czech Republic, 26601
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Novy Jicin, Czech Republic, 74101
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Prague, Czech Republic, 149 00
Finland
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Nurmijarvi, Finland, 01900
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Oulu, Finland, 90100
France
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La Bouexiere, France, 35340
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Murs Erigne, France, 49610
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Nantes, France, 44300
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Vieux Conde, France, 59690
Germany
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Gebhardshain, Germany, 57580
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Mainz, Germany, 55116
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Münster, Germany, 48145
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Neunkirchen, Germany, 66539
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Potsdam, Germany, 14469
India
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Bangalore, India, 560003
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Chennai, India, 600029
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Mumbai, India, 400053
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Nagpur, India, 440020
Korea, Republic of
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Bucheon, Korea, Republic of, 420-717
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Seoul, Korea, Republic of, 136 705
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Suwon-City, Korea, Republic of, 442-723
Mexico
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Mexico City, Mexico, 6700
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Monterrey, Mexico, 64461
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Tampico, Mexico, 89000
Poland
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Lodz, Poland, 90-242
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Warsaw, Poland, 02-091
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Wroclaw, Poland, 50-349
Puerto Rico
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Carolina, Puerto Rico, 00983
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Manati, Puerto Rico, 00674
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San Juan, Puerto Rico, 00987
Romania
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Bucharest, Romania, 020359
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Cluj-Napoca, Romania, 400006
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Galati, Romania, 800587
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Resita, Romania, 320076
Slovakia
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Banska Bystrica, Slovakia, 97405
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Bratislava, Slovakia, 821 03
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Trebisov, Slovakia, 07501
South Africa
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Halfway House, South Africa, 1685
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Kempton Park, South Africa, 1619
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Somerset West, South Africa, 7130
Spain
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Begonte, Spain, 27373
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Granada, Spain, 18012
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Seville, Spain, 41003
United Kingdom
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Penzance, Cornwall, United Kingdom, TR19 7HX
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Durham, County Durham, United Kingdom, DH1 2QW
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London, Greater London, United Kingdom, W9 1SP
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Cleveleys, Lancashire, United Kingdom, FY5 3LF
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Crawley, United Kingdom, RH10 7DX
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Nottingham, United Kingdom, NG3 7DQ
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01126580     History of Changes
Other Study ID Numbers: 11375, H9X-MC-GBDC, CTRI/2010/091/003036
Study First Received: May 18, 2010
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Croatia: Ethics Committee
Czech Republic: Ethics Committee
Finland: National Advisory Board on Health Care Ethics
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
India: Ministry of Health
Mexico: Ministry of Health
Poland: Ministry of Health
Romania: Ethics Committee
Slovakia: State Institute for Drug Control
South Africa: Human Research Ethics Committee
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Ministry of Health
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014