A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)
NCT ID: NCT01191268
Last Updated: 2014-10-08
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
884 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-11-30
Study Completion Date
2012-09-30
Brief Summary
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The purpose of this study is to assess the efficacy and safety of LY2189265 in comparison to Insulin Glargine, both in combination with Insulin Lispro (plus or minus Metformin), in participants with Type 2 Diabetes treated with 1 or 2 injections of insulin.
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Detailed Description
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The term rescue therapy in this trial was defined as therapy for participants who met criteria for persistent severe hyperglycemia and therapy for participants who required new intervention for any other reason. The latter included participants who discontinued study drug due to adverse events, participant decision, or any other reason. 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, all measurements including those obtained after taking rescue therapy were included in the analysis.
Conditions
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Diabetes Mellitus, Type 2
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Insulin Glargine
Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks
Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks
Group Type
ACTIVE_COMPARATOR
Insulin Glargine
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Interventions
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Insulin Glargine
Intervention Type
DRUG
LY2189265
Intervention Type
DRUG
Insulin Lispro
Intervention Type
DRUG
Other Intervention Names
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Dulaglutide
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes
* Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
* Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
* Willing to inject subcutaneous medication
* Willing to monitor blood glucose levels and adjust insulin dose
* Willing to maintain a study diary
* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2)
* Stable weight for 3 months prior to screening
* Females of child bearing potential must test negative for pregnancy at screening 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
* Currently using insulin for at least 3 months with a conventional insulin regimen with or without oral medications
* Glycosylated hemoglobin (HbA1c) greater than or equal to 7% and less than or equal to 11%
* Willing to inject subcutaneous medication
* Willing to monitor blood glucose levels and adjust insulin dose
* Willing to maintain a study diary
* Body mass index (BMI) between 23 and 45 kilograms per square meter (kg/m\^2)
* Stable weight for 3 months prior to screening
* Females of child bearing potential must test negative for pregnancy at screening 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
* Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
* 1 or more episodes of ketoacidosis within 6 months prior to screening
* Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening
* Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
* Acute or chronic hepatitis or pancreatitis
* Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
* Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
* Organ transplant except cornea
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
* Known drug or alcohol abuse
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 study
* Previous therapy with glucagon-like peptide 1 (GLP-1) agonists within 3 months prior to screening
* 1 or more episodes of ketoacidosis within 6 months prior to screening
* Have been treated with prescription or over the counter medication to promote weight loss within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) less than or equal to 30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2) at screening
* Taking steroids for greater than 14 days except for topical, eye, nasal, or inhaled
* History of heart failure, New York Heart Classification III or IV within 2 months prior to screening
* Gastrointestinal (GI) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking medications that directly affect GI motility
* Acute or chronic hepatitis or pancreatitis
* Self or family history of 2A or type 2B multiple endocrine neoplasia or medullary C-Cell hyperplasia
* Serum calcitonin greater than or equal to 20 picograms per milliliter (pcg/mL) at screening
* Organ transplant except cornea
* Significant active autoimmune disease such as Lupus or Rheumatoid Arthritis
* History of or active malignancy except skin or in situ cervical or prostate cancer within the last 5 years
* Known drug or alcohol abuse
* Have enrolled in another clinical trial within the last 30 days
* Have previously signed an informed consent or participated in a LY2189265 study
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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Concord, California, United States
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La Mesa, California, United States
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Lancaster, California, United States
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New Britain, Connecticut, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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West Palm Beach, Florida, United States
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Winter Haven, Florida, United States
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Honolulu, Hawaii, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Lexington, Kentucky, United States
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Paducah, Kentucky, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Haverhill, Massachusetts, United States
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Springfield, Massachusetts, United States
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Waltham, Massachusetts, United States
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Worcester, Massachusetts, United States
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Minneapolis, Minnesota, United States
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Chesterfield, Missouri, United States
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Nashua, New Hampshire, United States
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Toms River, New Jersey, United States
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Asheville, North Carolina, United States
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Morehead City, North Carolina, United States
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Fargo, North Dakota, United States
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Eugene, Oregon, United States
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Myrtle Beach, South Carolina, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Federal Way, Washington, United States
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Renton, Washington, United States
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Vancouver, Washington, United States
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Wenatchee, Washington, United States
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Buenos Aires, , Argentina
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Cipolletti, , Argentina
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Mendoza, , Argentina
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Salta, , Argentina
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Keswick, South Australia, Australia
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Box Hill, Victoria, Australia
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Melbourne, Victoria, Australia
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Bonheiden, , Belgium
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Brussels, , Belgium
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Genk, , Belgium
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Liège, , Belgium
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Belém, , Brazil
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Fortaleza, , Brazil
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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New Westminster, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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London, Ontario, Canada
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Gatineau, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Aarhus, , Denmark
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Copenhagen, , Denmark
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Hillerød, , Denmark
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Koege, , Denmark
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Kolding, , Denmark
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Ampelokipoi, , Greece
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Athens, , Greece
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Nikaias - Piraeus, , Greece
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Thessaloniki, , Greece
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Miskolc, , Hungary
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Nagykanizsa, , Hungary
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Nyíregyháza, , Hungary
Site Status
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Pápa, , Hungary
Site Status
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Culiacán, , Mexico
Site Status
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Guadalajara, , Mexico
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Mérida, , Mexico
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Monterrey, , Mexico
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Gdynia, , Poland
Site Status
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Lodz, , Poland
Site Status
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Radzymin, , Poland
Site Status
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Wroclaw, , Poland
Site Status
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Manatí, , Puerto Rico
Site Status
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Ponce, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Yabucoa, , Puerto Rico
Site Status
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Moscow, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Samara, , Russia
Site Status
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Barcelona, , Spain
Site Status
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Madrid, , Spain
Site Status
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Palma de Mallorca, , Spain
Site Status
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Pozuelo de Alarcón, , Spain
Site Status
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Teruel, , Spain
Site Status
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Valencia, , Spain
Site Status
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Karlstad, , Sweden
Site Status
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Lund, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Sindian City, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taipei, , Taiwan
Site Status
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Yongkang District, , Taiwan
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Argentina
Australia
Belgium
Brazil
Canada
Denmark
Greece
Hungary
Mexico
Poland
Puerto Rico
Russia
Spain
Sweden
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
Pantalone KM, Patel H, Yu M, Fernandez Lando L. Dulaglutide 1.5 mg as an add-on option for patients uncontrolled on insulin: Subgroup analysis by age, duration of diabetes and baseline glycated haemoglobin concentration. Diabetes Obes Metab. 2018 Jun;20(6):1461-1469. doi: 10.1111/dom.13252. Epub 2018 Mar 23.
Reference Type
DERIVED
Boustani MA, Pittman I 4th, Yu M, Thieu VT, Varnado OJ, Juneja R. Similar efficacy and safety of once-weekly dulaglutide in patients with type 2 diabetes aged >/=65 and <65 years. Diabetes Obes Metab. 2016 Aug;18(8):820-8. doi: 10.1111/dom.12687. Epub 2016 Jun 7.
Reference Type
DERIVED
Yu M, Van Brunt K, Varnado OJ, Boye KS. Patient-reported outcome results in patients with type 2 diabetes treated with once-weekly dulaglutide: data from the AWARD phase III clinical trial programme. Diabetes Obes Metab. 2016 Apr;18(4):419-24. doi: 10.1111/dom.12624. Epub 2016 Feb 4.
Reference Type
DERIVED
Blonde L, Jendle J, Gross J, Woo V, Jiang H, Fahrbach JL, Milicevic Z. Once-weekly dulaglutide versus bedtime insulin glargine, both in combination with prandial insulin lispro, in patients with type 2 diabetes (AWARD-4): a randomised, open-label, phase 3, non-inferiority study. Lancet. 2015 May 23;385(9982):2057-66. doi: 10.1016/S0140-6736(15)60936-9.
Reference Type
DERIVED
Other Identifiers
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H9X-MC-GBDD
Identifier Type: OTHER
Identifier Source: secondary_id
11376
Identifier Type: -
Identifier Source: org_study_id
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