NCT01624259

Brief Summary

The purpose of the study is to assess the benefits and risks of once-weekly dulaglutide compared to once-daily liraglutide in participants with type 2 diabetes who have inadequate glycemic control on metformin.

Trial Health

98
On Track

Trial Health Score

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

Enrollment
599

participants targeted

Target at P50-P75 for phase_3 type-2-diabetes

Timeline
Completed

Started Jun 2012

Shorter than P25 for phase_3 type-2-diabetes

Geographic Reach
10 countries

57 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

June 1, 2012

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

October 9, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

1.4 years

First QC Date

June 18, 2012

Results QC Date

October 3, 2014

Last Update Submit

October 3, 2014

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline to 26 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

    Least Squares (LS) means of the glycosylated hemoglobin A1c (HbA1c) change from baseline to the primary endpoint at Week 26 was adjusted by fixed effects of treatment, country, visit, treatment-by-visit interaction, participant as random effect, and baseline HbA1c as covariates, via a mixed-effects model for repeated measures (MMRM) analysis using restricted maximum likelihood (REML).

    Baseline, 26 Weeks

Secondary Outcomes (22)

  • Change From Baseline in Body Weight at 26 Weeks

    Baseline, Up to 26 Weeks

  • Change From Baseline in Body Mass Index (BMI) at 26 Weeks

    Baseline, Up to 26 Weeks

  • Change From Baseline in Fasting Plasma Glucose (FPG) at 26 Weeks

    Baseline, Up to 26 Weeks

  • Change From Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks

    Baseline, 26 Weeks

  • Percentage of Participants Achieving a Glycosylated Hemoglobin (HbA1c) ≤6.5% or <7% at 26 Weeks

    Up to 26 Weeks

  • +17 more secondary outcomes

Study Arms (2)

1.5 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

Drug: LY2189265Drug: Metformin

Liraglutide

ACTIVE COMPARATOR

Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.2 mg, SC, once daily for 7 days, then titrated up to Liraglutide 1.8 mg, SC, once daily for 24 weeks Metformin: at least 1500 mg/day, oral, for 26 weeks

Drug: LiraglutideDrug: Metformin

Interventions

LY2189265DRUG

Administered SC

Also known as: Dulaglutide
1.5 mg LY2189265
LiraglutideDRUG

Administered SC

Liraglutide
MetforminDRUG
1.5 mg LY2189265Liraglutide

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes
  • Not optimally controlled on diet and exercise and a dose of metformin that is at least 1500 milligrams/day (mg/day) and has been at a stable dose for at least 3 months prior to the first study visit
  • Glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than or equal to 10.0%
  • Accept continued treatment with metformin throughout the trial, as required per protocol
  • Men and nonpregnant women aged greater than or equal to 18 years
  • Stable weight (plus or minus 5%) greater than or equal to 3 months prior to screening
  • Body Mass Index (BMI) less than or equal to 45 kilograms/square meter (kg/m\^2)

You may not qualify if:

  • Have type 1 diabetes mellitus
  • Have been treated with ANY other antihyperglycemic medications (other than metformin) at the time of the first study visit or within the 3 months prior to the first study visit
  • Have used insulin therapy (outside of pregnancy) any time in the past 2 years, except for short-term treatment of acute conditions, and up to a maximum of 4 weeks; any insulin use within 3 months prior to the first study visit
  • Have been treated with drugs that promote weight loss within 3 months of the first study visit
  • Are receiving chronic (greater than 14 days) systemic glucocorticoid therapy or have received such therapy within the 4 weeks immediately prior to the first study visit
  • Have had any of the following cardiovascular conditions within 2 months prior to the first study visit: acute myocardial infarction, New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident
  • Have a known clinically significant gastric emptying abnormality (such as, severe diabetic gastroparesis or gastric outlet obstruction) or have undergone gastric bypass (bariatric) surgery or restrictive bariatric surgery
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease, or alanine transaminase level greater than or equal to 3 times the upper limit of normal
  • Have a history of chronic pancreatitis or acute idiopathic pancreatitis or were diagnosed with any type of acute pancreatitis within the 3 month period prior to the first study visit
  • Have a serum creatinine greater than or equal to 1.5 milligrams/deciliter (mg/dL) (male) or greater than or equal to 1.4 mg/dL (female), or a creatinine clearance less than 60 milliliters/minute (mL/minute)
  • Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, or carcinoma (including sporadic, familial, or part of MEN 2A or 2B syndrome)
  • Have a serum calcitonin greater than or equal to 20 picograms/milliliter (pg/mL)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

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Phoenix, Arizona, 85027, United States

Location

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Chino, California, 91710, United States

Location

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Fresno, California, 93720, United States

Location

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Los Angeles, California, 90057, United States

Location

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Spring Valley, California, 91978, United States

Location

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Fort Lauderdale, Florida, 33316, United States

Location

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Miami, Florida, 33175, United States

Location

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Oviedo, Florida, 32765, United States

Location

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Topeka, Kansas, 66606, United States

Location

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Louisville, Kentucky, 40218, United States

Location

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Shreveport, Louisiana, 71101, United States

Location

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Royal Oak, Michigan, 48073, United States

Location

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Las Vegas, Nevada, 89119, United States

Location

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Perrysburg, Ohio, 43551, United States

Location

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Kingsport, Tennessee, 37660, United States

Location

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Dallas, Texas, 75230, United States

Location

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Hurst, Texas, 76054, United States

Location

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San Antonio, Texas, 78228, United States

Location

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Prague, 181 00, Czechia

Location

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Dresden, 01307, Germany

Location

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Hohenmölsen, 06679, Germany

Location

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Lingen, 49808, Germany

Location

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Mainz, 55116, Germany

Location

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Neunkirchen, 66539, Germany

Location

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Saint Ingbert-Oberwürzbach, 66386, Germany

Location

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Sulzbach, 92237, Germany

Location

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Budapest, H-1139, Hungary

Location

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Debrecen, 4043, Hungary

Location

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Dombóvár, 7200, Hungary

Location

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Székesfehérvár, 8000, Hungary

Location

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Monterrey, 64620, Mexico

Location

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Bialystok, 15-445, Poland

Location

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Gdansk, 80-546, Poland

Location

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Kamieniec Ząbkowicki, 57-230, Poland

Location

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Lodz, 90-242, Poland

Location

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Poznan, 61-853, Poland

Location

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Ruda Śląska, 41-709, Poland

Location

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Szczecin, 70-506, Poland

Location

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Tychy, 43-100, Poland

Location

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Wroclaw, 50-306, Poland

Location

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Hato Rey, 00917, Puerto Rico

Location

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Río Grande, 00745, Puerto Rico

Location

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Bucharest, 020045, Romania

Location

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Galati, 800098, Romania

Location

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Ploieşti, 100342, Romania

Location

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Sibiu, 550371, Romania

Location

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Košice, 04012, Slovakia

Location

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Malacky, 90101, Slovakia

Location

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Nitra, 94901, Slovakia

Location

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Nové Mesto nad Váhom, 91501, Slovakia

Location

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Alicante, 03114, Spain

Location

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Alzira, 46600, Spain

Location

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Barcelona, 08022, Spain

Location

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Centelles, 08540, Spain

Location

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Málaga, 29006, Spain

Location

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Palma de Mallorca, 07014, Spain

Location

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Petrel, 03610, Spain

Location

Related Publications (3)

  • 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

  • Dungan KM, Povedano ST, Forst T, Gonzalez JG, Atisso C, Sealls W, Fahrbach JL. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014 Oct 11;384(9951):1349-57. doi: 10.1016/S0140-6736(14)60976-4. Epub 2014 Jul 10.

    PMID: 25018121DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideLiraglutideMetformin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsBiguanidesGuanidinesAmidinesOrganic 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 DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2012

First Posted

June 20, 2012

Study Start

June 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 9, 2014

Results First Posted

October 9, 2014

Record last verified: 2014-10

Locations

US(18)CZ(1)ES(7)HU(4)ME(1)PR(2)DE(7)RO(4)PL(9)SL(4)