A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin
NCT ID: NCT00734474
Last Updated: 2015-04-20
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
1202 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-08-31
Study Completion Date
2012-07-31
Brief Summary
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This is an adaptive dose finding study and a Phase 3 efficacy study to evaluate the effects of once weekly injection of LY2189265 compared to Sitagliptin on glucose by measuring glycosylated hemoglobin (HbA1c) change from baseline after 52 weeks in participants with type 2 diabetes mellitus on Metformin.
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Detailed Description
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This is a double blind study designed to select 1 or 2 LY2189265 doses for evaluation in Phase 3 studies (dose-finding portion) and to evaluate efficacy and safety of selected doses of LY2189265 in comparison to Sitagliptin (100 milligrams) up to 104 weeks and Placebo up to 26 weeks in participants with type 2 diabetes mellitus on Metformin (confirmatory, Phase 3 portion). The primary objective is to show non-inferiority of the higher LY2189265 dose (if 2 doses are selected) to Sitagliptin with respect to change in glycosylated hemoglobin (HbA1c) at 52 weeks. The final endpoint is 104 weeks.
Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265 doses until a dose decision is made based on quantitative analysis of the benefits and risks of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this end. After the dose decision, participants in the selected LY2189265 arms and the comparator arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional participants will be randomized to the selected and comparator arms. Regardless of the timing of randomization relative to the dose decision point, all participants in the selected and comparator arms are planned to receive treatment for 104 weeks; participants in the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain blinded to their study treatment throughout the study. Participants in the non-selected arms will discontinue from the study after the dose decision
Participants are randomized to receive Placebo, Sitagliptin, or 1 of 7 initial LY2189265 doses until a dose decision is made based on quantitative analysis of the benefits and risks of each LY2189265 dose. A clinical utility index (CUI) that applies predicted values for change from baseline in HbA1c at 12 months and change from baseline in weight, diastolic blood pressure, and pulse rate at 6 months for each LY2189265 dose will be used toward this end. After the dose decision, participants in the selected LY2189265 arms and the comparator arms (Sitagliptin and Placebo/Sitagliptin arms) will continue the study, and additional participants will be randomized to the selected and comparator arms. Regardless of the timing of randomization relative to the dose decision point, all participants in the selected and comparator arms are planned to receive treatment for 104 weeks; participants in the Placebo/Sitagliptin arm will receive Placebo treatment for 26 weeks followed by Sitagliptin 100 mg for 78 weeks for blinding purposes only, and participants in the selected and Sitagliptin arms will receive the same treatment for 104 weeks. All participants will remain blinded to their study treatment throughout the study. Participants in the non-selected arms will discontinue from the study after the dose decision
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
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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3.0 mg LY2189265
LY2189265 (Dulaglutide): 3.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
2.0 mg LY2189265
LY2189265 (Dulaglutide): 2.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
1.5 mg LY2189265
LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
1.0 mg LY2189265
LY2189265 (Dulaglutide): 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
0.75 mg LY2189265
LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
0.5 mg LY2189265
LY2189265 (Dulaglutide): 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
0.25 mg LY2189265
LY2189265 (Dulaglutide): 0.25 milligrams (mg), subcutaneous (SC) injection, once weekly for up to 104 weeks
Placebo: tablet, administered orally, once daily for up to 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for up to 104 weeks
Group Type
EXPERIMENTAL
LY2189265
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Sitagliptin
Sitagliptin: 100-milligrams (mg) tablet, administered orally, once daily for 104 weeks
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks
Group Type
ACTIVE_COMPARATOR
Sitagliptin
Intervention Type
DRUG
Placebo solution
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Placebo/Sitagliptin (Baseline Through 104 Weeks)
Placebo: solution, subcutaneous (SC) injection, once weekly for 104 weeks
Placebo: tablet, administered orally, once daily for 26 weeks
Sitagliptin: after 26 weeks, 100-milligrams (mg) tablet, administered orally, once daily for 78 weeks
Metformin: at least 1500 milligrams per day (mg/day), administered orally for 104 weeks
Group Type
PLACEBO_COMPARATOR
Placebo solution
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Interventions
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LY2189265
Intervention Type
DRUG
Sitagliptin
Intervention Type
DRUG
Placebo solution
Intervention Type
DRUG
Placebo tablet
Intervention Type
DRUG
Metformin
Intervention Type
DRUG
Other Intervention Names
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Dulaglutide
Trulicity
Eligibility Criteria
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Inclusion Criteria
* Diabetes mellitus, type 2, for at least 6 months
* Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.
* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of \>8.0% to ≤9.5%
* Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m\^2), inclusive
* Stable weight for 3 months prior to screening
* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
* Treatment regimens: diet and exercise, metformin as monotherapy or in combination with another oral antihyperglycemic medication (OAM), or another OAM as monotherapy. Must be able to tolerate metformin at a dose of at least 1500 milligrams (mg) daily for 6 weeks prior to randomization.
* Glycosylated hemoglobin (HbA1c) value of ≥7.0% to ≤9.5%, except participants on diet and exercise therapy who must have had HbA1c value of \>8.0% to ≤9.5%
* Body mass index (BMI) between 25 and 40 kilograms per meter squared (kg/m\^2), inclusive
* Stable weight for 3 months prior to screening
* Females of childbearing potential must test negative for pregnancy and agree to use a reliable birth control method
Exclusion Criteria
* Diabetes mellitus, type 1
* Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin
* Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility
* Use of medications to promote weight loss
* Clinically-relevant cardiovascular event within 6 months prior to screening
* Poorly controlled hypertension
* Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease
* Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels \>3.0 times the upper limit of normal
* Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance \<60 milliliters per minute (mL/minute)
* Uncontrolled diabetes, defined as \>2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.
* Uncontrolled endocrine or autoimmune abnormality
* History of a transplanted organ
* Chronic use of systemic glucocorticoid therapy
* Active or untreated malignancy
* Use of central nervous system (CNS) stimulants
* Use of a glucagon-like peptide-1 (GLP-1) analog (for example, exenatide) within 6 months prior to screening or are being treated with insulin
* Gastric emptying abnormality, history of bariatric surgery, or chronic use of drugs that affect gastrointestinal motility
* Use of medications to promote weight loss
* Clinically-relevant cardiovascular event within 6 months prior to screening
* Poorly controlled hypertension
* Electrocardiogram (ECG) reading considered outside the normal limits or indicating cardiac disease
* Liver disease, hepatitis, chronic pancreatitis, idiopathic acute pancreatitis, or alanine transaminase (ALT) levels \>3.0 times the upper limit of normal
* Serum creatinine ≥1.5 milligrams per deciliter (mg/dL) or a creatinine clearance \<60 milliliters per minute (mL/minute)
* Uncontrolled diabetes, defined as \>2 episodes of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to study entry.
* Uncontrolled endocrine or autoimmune abnormality
* History of a transplanted organ
* Chronic use of systemic glucocorticoid therapy
* Active or untreated malignancy
* Use of central nervous system (CNS) stimulants
Minimum Eligible Age
18 Years
Maximum Eligible Age
75 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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United BioSource, LLC
INDUSTRY
Sponsor Role
collaborator
Tessella Inc.
INDUSTRY
Sponsor Role
collaborator
Berry Consultants
OTHER
Sponsor Role
collaborator
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_CHAIR
Eli Lilly and Company
Locations
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Fresno, California, United States
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Mission Hills, California, United States
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Longmont, Colorado, United States
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Waterbury, Connecticut, United States
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Hollywood, Florida, United States
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West Palm Beach, Florida, United States
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Athens, Georgia, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Springfield, Illinois, United States
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Topeka, Kansas, United States
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Metairie, Louisiana, United States
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Biddeford, Maine, United States
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Ann Arbor, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Southfield, Michigan, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Las Vegas, Nevada, United States
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Rochester, New York, United States
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Syracuse, New York, United States
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Greensboro, North Carolina, United States
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Morehead City, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Corvallis, Oregon, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Georgetown, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Federal Way, Washington, United States
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Tacoma, Washington, United States
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Calgary, Alberta, Canada
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Winnipeg, Manitoba, Canada
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Oakville, Ontario, Canada
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Sherbrooke, Quebec, Canada
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Corbeil-Essonnes, , France
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La Rochelle, , France
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Mantes-la-Jolie, , France
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Montpellier, , France
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Narbonne, , France
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Saint-Mandé, , France
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Strasbourg, , France
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Toul, , France
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Vénissieux, , France
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Aschaffenburg, , Germany
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Bad Lauterberg im Harz, , Germany
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Bad Staffelstein, , Germany
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Bochum, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Hirschhorn, , Germany
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Mainz, , Germany
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Münster, , Germany
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Neuwied, , Germany
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Pohlheim, , Germany
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Rotenburg-Fulda, , Germany
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Ahmedabad, , India
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Bangalore, , India
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Ghaziabad, , India
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Kochi, , India
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Pune, , India
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Gdynia, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Szczecin, , Poland
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Wroclaw, , Poland
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Manatí, , Puerto Rico
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San Juan, , Puerto Rico
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Baia Mare, , Romania
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Cluj-Napoca, , Romania
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Timișoara, , Romania
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Arkhangelsk, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Goyang-si, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Sungnam-Si, , South Korea
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Dos Hermanas, , Spain
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Lleida, , Spain
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Málaga, , Spain
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Palma de Mallorca, , Spain
Site Status
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Pozuelo de Alarcón, , Spain
Site Status
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Chiayi City, , Taiwan
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Kaohsiung City, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Tainan City, , Taiwan
Site Status
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Taipei, , Taiwan
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Yung-Kang, Tainan, , Taiwan
Site Status
Countries
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United States
Canada
France
Germany
India
Mexico
Poland
Puerto Rico
Romania
Russia
South Korea
Spain
Taiwan
References
Explore related publications, articles, or registry entries linked to this study.
Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
Reference Type
DERIVED
Sherman SI, Kloos RT, Tuttle RM, Pontecorvi A, Volzke H, Harper K, Vance C, Alston JT, Usborne AL, Sloop KW, Lakshmanan M. No calcitonin change in a person taking dulaglutide diagnosed with pre-existing medullary thyroid cancer. Diabet Med. 2018 Mar;35(3):381-385. doi: 10.1111/dme.13437.
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
Weinstock RS, Guerci B, Umpierrez G, Nauck MA, Skrivanek Z, Milicevic Z. Safety and efficacy of once-weekly dulaglutide versus sitagliptin after 2 years in metformin-treated patients with type 2 diabetes (AWARD-5): a randomized, phase III study. Diabetes Obes Metab. 2015 Sep;17(9):849-58. doi: 10.1111/dom.12479. Epub 2015 May 20.
Reference Type
DERIVED
Skrivanek Z, Gaydos BL, Chien JY, Geiger MJ, Heathman MA, Berry S, Anderson JH, Forst T, Milicevic Z, Berry D. Dose-finding results in an adaptive, seamless, randomized trial of once-weekly dulaglutide combined with metformin in type 2 diabetes patients (AWARD-5). Diabetes Obes Metab. 2014 Aug;16(8):748-56. doi: 10.1111/dom.12305. Epub 2014 May 22.
Reference Type
DERIVED
Spencer K, Colvin K, Braunecker B, Brackman M, Ripley J, Hines P, Skrivanek Z, Gaydos B, Geiger MJ. Operational challenges and solutions with implementation of an adaptive seamless phase 2/3 study. J Diabetes Sci Technol. 2012 Nov 1;6(6):1296-304. doi: 10.1177/193229681200600608.
Reference Type
DERIVED
Other Identifiers
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H9X-MC-GBCF
Identifier Type: OTHER
Identifier Source: secondary_id
CTRI/2009/091/000969
Identifier Type: REGISTRY
Identifier Source: secondary_id
11422
Identifier Type: -
Identifier Source: org_study_id
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