NCT00734474

Brief Summary

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.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,202

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_2 diabetes-mellitus-type-2

Geographic Reach
13 countries

99 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

January 28, 2015

Completed
Last Updated

April 20, 2015

Status Verified

March 1, 2015

Enrollment Period

2.8 years

First QC Date

August 12, 2008

Results QC Date

October 3, 2014

Last Update Submit

March 31, 2015

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes, type 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • Glycosylated Hemoglobin (HbA1c) Change From Baseline

    Least squares (LS) means were calculated using analysis of covariance (ANCOVA) and last observation carried forward (LOCF) imputation with country and treatment as fixed effects and baseline HbA1c as a covariate.

    Baseline, 52 weeks

Secondary Outcomes (30)

  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at the Dose Decision Point

    Baseline up to 27.4 weeks

  • Glycosylated Hemoglobin (HbA1c) Change From Baseline

    Baseline, 26 weeks, 104 weeks

  • Durability of Change From Baseline in Glycosylated Hemoglobin (HbA1c)

    Baseline, 13, 26, 52, and 104 weeks

  • Fasting Blood Glucose Change From Baseline

    Baseline, 26, 52, and 104 weeks

  • Fasting Insulin Change From Baseline

    Baseline, 26, 52, and 104 weeks

  • +25 more secondary outcomes

Other Outcomes (2)

  • Number of Participants With Adjudicated Pancreatitis at 104 Weeks

    Baseline through 104 weeks

  • Number of Participants With Adjudicated Cardiovascular Events at 104 Weeks

    Baseline through 104 weeks

Study Arms (9)

3.0 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

2.0 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

1.5 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

1.0 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

0.75 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

0.5 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

0.25 mg LY2189265

EXPERIMENTAL

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

Drug: LY2189265Drug: Placebo tabletDrug: Metformin

Sitagliptin

ACTIVE COMPARATOR

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

Drug: SitagliptinDrug: Placebo solutionDrug: Metformin

Placebo/Sitagliptin (Baseline Through 104 Weeks)

PLACEBO COMPARATOR

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

Drug: Placebo solutionDrug: Placebo tabletDrug: Metformin

Interventions

LY2189265DRUG
Also known as: Dulaglutide, Trulicity
0.25 mg LY21892650.5 mg LY21892650.75 mg LY21892651.0 mg LY21892651.5 mg LY21892652.0 mg LY21892653.0 mg LY2189265
SitagliptinDRUG
Sitagliptin
Placebo solutionDRUG
Placebo/Sitagliptin (Baseline Through 104 Weeks)Sitagliptin
Placebo tabletDRUG
0.25 mg LY21892650.5 mg LY21892650.75 mg LY21892651.0 mg LY21892651.5 mg LY21892652.0 mg LY21892653.0 mg LY2189265Placebo/Sitagliptin (Baseline Through 104 Weeks)
MetforminDRUG
0.25 mg LY21892650.5 mg LY21892650.75 mg LY21892651.0 mg LY21892651.5 mg LY21892652.0 mg LY21892653.0 mg LY2189265Placebo/Sitagliptin (Baseline Through 104 Weeks)Sitagliptin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (99)

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Peoria, Arizona, 85381, United States

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Phoenix, Arizona, 85050, United States

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Tucson, Arizona, 85741, United States

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Fresno, California, 93726, United States

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Mission Hills, California, 91345, United States

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Longmont, Colorado, 80501, United States

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Waterbury, Connecticut, 06708, United States

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Hollywood, Florida, 33021, United States

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West Palm Beach, Florida, 33401, United States

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Athens, Georgia, 30606, United States

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Atlanta, Georgia, 30303, United States

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Idaho Falls, Idaho, 83404, United States

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Springfield, Illinois, 62704, United States

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Topeka, Kansas, 66606, United States

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Metairie, Louisiana, 70006, United States

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Biddeford, Maine, 04005, United States

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Ann Arbor, Michigan, 48106, United States

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Saint Clair Shores, Michigan, 48081, United States

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Southfield, Michigan, 48075, United States

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St Louis, Missouri, 63141, United States

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Billings, Montana, 59101, United States

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Las Vegas, Nevada, 89101, United States

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Rochester, New York, 14607, United States

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Syracuse, New York, 13210, United States

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Greensboro, North Carolina, 27401, United States

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Morehead City, North Carolina, 28557, United States

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Winston-Salem, North Carolina, 27103, United States

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Corvallis, Oregon, 97330, United States

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Charleston, South Carolina, 29412, United States

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Dallas, Texas, 75230, United States

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Georgetown, Texas, 78626, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78229, United States

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Federal Way, Washington, 98003, United States

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Tacoma, Washington, 98405, United States

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Calgary, Alberta, T2H 2G4, Canada

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Winnipeg, Manitoba, R3P 3P4, Canada

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Oakville, Ontario, L6H 3P1, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Corbeil-Essonnes, 91106, France

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La Rochelle, 17019, France

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Mantes-la-Jolie, 78200, France

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Montpellier, F-34295, France

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Narbonne, 11108, France

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Saint-Mandé, 94160, France

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Strasbourg, 67000, France

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Toul, 54201, France

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Vénissieux, 69200, France

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Aschaffenburg, 63739, Germany

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Bad Lauterberg im Harz, D-37431, Germany

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Bad Staffelstein, D-96231, Germany

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Bochum, D-44791, Germany

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Essen, 45355, Germany

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Hamburg, 21073, Germany

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Hirschhorn, 69434, Germany

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Mainz, D-55116, Germany

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Münster, 48145, Germany

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Neuwied, 56564, Germany

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Pohlheim, D-35415, Germany

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Rotenburg-Fulda, 36199, Germany

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Ahmedabad, 380006, India

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Bangalore, 560038, India

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Ghaziabad, 201 002, India

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Kochi, 682026, India

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Pune, 411005, India

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Aguascalientes, 20129, Mexico

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Chihuahua City, 31238, Mexico

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Guadalajara, 44600, Mexico

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Monterrey, 64461, Mexico

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Gdynia, 81-557, Poland

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Lodz, 93-319, Poland

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Lublin, 20-954, Poland

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Szczecin, 70-506, Poland

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Wroclaw, 50-403, Poland

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Manatí, 00674, Puerto Rico

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San Juan, 00907, Puerto Rico

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Baia Mare, 430123, Romania

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Cluj-Napoca, 400006, Romania

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Timișoara, 300736, Romania

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Arkhangelsk, 163045, Russia

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Rostov-on-Don, 344022, Russia

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Saint Petersburg, 193257, Russia

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Goyang-si, 410-719, South Korea

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Incheon, 400-711, South Korea

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Seongnam-si, 463-707, South Korea

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Seoul, 139-872, South Korea

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Sungnam-Si, 463-712, South Korea

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Dos Hermanas, 41014, Spain

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Lleida, 25198, Spain

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Málaga, 29010, Spain

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Palma de Mallorca, 07010, Spain

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Pozuelo de Alarcón, 28223, Spain

Location

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Chiayi City, 600, Taiwan

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Kaohsiung City, 807, Taiwan

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Taichung, 40201, Taiwan

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Taichung, 407, Taiwan

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Tainan, 70403, Taiwan

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Taipei, 100, Taiwan

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Yung-Kang, Tainan, 710, Taiwan

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Related Publications (7)

  • 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.

    PMID: 36894938DERIVED

  • 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.

    PMID: 28755389DERIVED

  • 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.

    PMID: 27161178DERIVED

  • 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.

    PMID: 26691396DERIVED

  • 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.

    PMID: 25912221DERIVED

  • 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.

    PMID: 24762094DERIVED

  • 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.

    PMID: 23294774DERIVED

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideSitagliptin PhosphateMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazinesBiguanidesGuanidinesAmidinesOrganic Chemicals

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
800-545-5979

Study Officials

  • 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

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2008

First Posted

August 14, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

July 1, 2012

Last Updated

April 20, 2015

Results First Posted

January 28, 2015

Record last verified: 2015-03

Locations

DE(12)IN(5)PL(5)PR(2)RO(3)KR(5)CA(4)RU(3)US(35)TW(7)ME(4)ES(5)FR(9)