A Study in Participants With Type 2 Diabetes Mellitus (AWARD-2)
NCT ID: NCT01075282
Last Updated: 2015-01-16
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
810 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-02-28
Study Completion Date
2012-11-30
Brief Summary
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The purpose of this study is to determine if LY2189265 is effective in reducing hemoglobin A1c (HbA1c) and safe, as compared to Insulin Glargine in participants with Type 2 Diabetes. Participants must also be taking metformin and glimepiride.
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Detailed Description
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Rescue therapy refers to 1 of 2 types of additional therapy, each given for a different reason: any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation. Participants who received rescue therapy were included in the analysis population, but only measurements obtained prior to the beginning of rescue therapy were included in specified efficacy analyses.
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
NONE
Study Groups
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LY2189265 1.5 mg
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Glimepiride
Intervention Type
DRUG
LY2189265 0.75 mg
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Glimepiride
Intervention Type
DRUG
Insulin Glargine
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks
Glimepiride: at least 4 mg/day, oral, for 78 weeks
Group Type
ACTIVE_COMPARATOR
Insulin Glargine
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Glimepiride
Intervention Type
DRUG
Interventions
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Insulin Glargine
Intervention Type
DRUG
LY2189265
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Glimepiride
Intervention Type
DRUG
Other Intervention Names
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Dulaglutide
Eligibility Criteria
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Inclusion Criteria
* Type 2 Diabetes not well controlled on 1, 2, or 3 oral antidiabetic medications (at least one of them must be metformin and/or a sulfonylurea)
1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
* Accept treatment with metformin and glimepiride throughout the study, as per protocol
* Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
* Stable weight for 3 months prior to screening
* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2)
* Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
1. Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
2. HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
* Accept treatment with metformin and glimepiride throughout the study, as per protocol
* Willing to inject subcutaneous medication once weekly for LY2189265 or once daily for Insulin Glargine.
* Stable weight for 3 months prior to screening
* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2)
* Females of child bearing potential must test negative for pregnancy at screening by serum pregnancy test and be willing to use a reliable method of birth control during the study and for 1 month following the last dose of study drug
Exclusion Criteria
* Type 1 Diabetes
* HbA1c equal to or less than 6.5 at randomization
* Chronic insulin use
* Taking drugs to promote weight loss by prescription or over the counter
* Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
* Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
* Acute or chronic pancreatitis of any form
* Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
* History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
* A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
* Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
* Organ transplant except cornea
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 study
* Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
* HbA1c equal to or less than 6.5 at randomization
* Chronic insulin use
* Taking drugs to promote weight loss by prescription or over the counter
* Taking systemic steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of Heart Failure New York Heart Classification III or IV, or acute myocardial infarction, or stroke within 2 months of screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
* Hepatitis or liver disease or ALT (alanine transaminase) greater than 3.0 of upper normal limit
* Acute or chronic pancreatitis of any form
* Renal disease (kidney) with a serum creatinine of greater than or equal to 1.5 milligrams per deciliter (mg/dL) for males and greater than or equal to 1.4 mg/dL for females, or a creatinine clearance of less than 60 milliliters per minute (ml/min)
* History (includes family) of type 2A or 2B Multiple Endocrine Neoplasia (MEN 2A or 2B) or medullary c-cell hyperplasia or thyroid cancer
* A serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/ml) at screening
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer for within last 5 years
* Sickle cell, hemolytic anemia, or other hematological condition that may interfere with HbA1c testing
* Organ transplant except cornea
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 study
* Have taken a glucagon-like peptide 1 (GLP-1) receptor agonist within the 3 months prior to screening
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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Buenos Aires, , Argentina
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Caba, , Argentina
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Córdoba, , Argentina
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Mendoza, , Argentina
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Wollongong, New South Wales, Australia
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Brisbane, Queensland, Australia
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Keswick, South Australia, Australia
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East Ringwood, Victoria, Australia
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Heidelberg, Victoria, Australia
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Gribomont, , Belgium
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Halen, , Belgium
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Leuven, , Belgium
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Joinville, , Brazil
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São Paulo, , Brazil
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Edmonton, Alberta, Canada
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Coquitlam, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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St. John's, Newfoundland and Labrador, Canada
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Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Osijek, , Croatia
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Slavonski Brod, , Croatia
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Zagreb, , Croatia
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Holešov, , Czechia
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Prague, , Czechia
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Corbeil-Essonnes, , France
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Dijon, , France
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Nantes, , France
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Pessac, , France
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Tours, , France
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Athens, , Greece
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Budapest, , Hungary
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Makó, , Hungary
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Mosonmagyaróvár, , Hungary
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Székesfehérvár, , Hungary
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Aligarh, , India
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Bangalore, , India
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Chennai, , India
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Indore, , India
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Jaipur, , India
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Mumbai, , India
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Patna, , India
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Florence, , Italy
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Milan, , Italy
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Coatzacoalcos, , Mexico
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Cuernavaca, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Bialystok, , Poland
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Bydogoszcz, , Poland
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Krakow, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Baia Mare, , Romania
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Bucharest, , Romania
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Galati, , Romania
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Oradea, , Romania
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Košice, , Slovakia
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Bucheon-si, , South Korea
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Ilsan, , South Korea
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Pusan, , South Korea
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Alicante, , Spain
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Ávila, , Spain
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Palencia, , Spain
Site Status
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Requena, , Spain
Site Status
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Gothenburg, , Sweden
Site Status
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Helsingborg, , Sweden
Site Status
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Lund, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
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Chiayi City, , Taiwan
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Tainan City, , Taiwan
Site Status
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.
Taipei, , Taiwan
Site Status
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.
Taoyuan District, , Taiwan
Site Status
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.
Yung-Kang, Tainan, , Taiwan
Site Status
Countries
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Argentina
Australia
Belgium
Brazil
Canada
Croatia
Czechia
France
Greece
Hungary
India
Italy
Mexico
Poland
Romania
Slovakia
South Korea
Spain
Sweden
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
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
Giorgino F, Benroubi M, Sun JH, Zimmermann AG, Pechtner V. Efficacy and Safety of Once-Weekly Dulaglutide Versus Insulin Glargine in Patients With Type 2 Diabetes on Metformin and Glimepiride (AWARD-2). Diabetes Care. 2015 Dec;38(12):2241-9. doi: 10.2337/dc14-1625. Epub 2015 Jun 18.
Reference Type
DERIVED
Other Identifiers
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H9X-MC-GBDB
Identifier Type: OTHER
Identifier Source: secondary_id
11374
Identifier Type: -
Identifier Source: org_study_id
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