NCT01064687

Brief Summary

The purpose of this study is to determine if LY2189265 is effective and safe in reducing hemoglobin A1c (HbA1c), as compared to placebo (no medicine), or exenatide in participants with Type 2 Diabetes. The participants must also be taking metformin and pioglitazone.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
978

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Feb 2010

Typical duration for phase_3 diabetes-mellitus-type-2

Geographic Reach
4 countries

89 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

February 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 8, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

January 26, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

February 5, 2010

Results QC Date

October 3, 2014

Last Update Submit

January 15, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

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

    Baseline, 26 weeks

Secondary Outcomes (46)

  • Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

    Baseline, 52 weeks

  • Change From Baseline to 26 Weeks for Body Weight

    Baseline, 26 weeks

  • Change From Baseline to 52 Weeks for Body Weight

    Baseline, 52 weeks

  • Change From Baseline to 26 Weeks on Body Mass Index (BMI)

    Baseline, 26 weeks

  • Change From Baseline to 52 Weeks on Body Mass Index (BMI)

    Baseline, 52 weeks

  • +41 more secondary outcomes

Study Arms (4)

1.5 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks

Drug: LY2189265Drug: MetforminDrug: Pioglitazone

0.75 mg LY2189265

EXPERIMENTAL

LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks

Drug: LY2189265Drug: MetforminDrug: Pioglitazone

Exenatide

ACTIVE COMPARATOR

Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks

Drug: ExenatideDrug: MetforminDrug: Pioglitazone

Placebo

PLACEBO COMPARATOR

Placebo: subcutaneous (SC), once weekly for 26 weeks LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52). Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks Pioglitazone: at least 30 mg/day, oral, for 52 weeks

Drug: LY2189265Drug: PlaceboDrug: MetforminDrug: Pioglitazone

Interventions

LY2189265DRUG
Also known as: Dulaglutide
0.75 mg LY21892651.5 mg LY2189265Placebo
ExenatideDRUG
Exenatide
PlaceboDRUG
Placebo
MetforminDRUG
0.75 mg LY21892651.5 mg LY2189265ExenatidePlacebo
PioglitazoneDRUG
0.75 mg LY21892651.5 mg LY2189265ExenatidePlacebo

Eligibility Criteria

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

You may qualify if:

  • Type 2 Diabetes (T2D) not well controlled on 1, 2, or 3 oral antidiabetic medications
  • Glycosylated hemoglobin (HbA1c) greater than or equal to 7 and less than or equal to 11 if taking 1 oral antidiabetic medication
  • HbA1c greater than or equal to 7 and less than or equal to 10 if on 2 or 3 oral antidiabetic medications
  • Able to tolerate minimum dose of 1500 milligrams (mg) metformin a day and 30 mg pioglitazone per day.
  • Willing to inject subcutaneous (SC) medication up to 2 times per day
  • Stable weight for 3 months prior to screening
  • Body mass index (BMI) between 23 and 45 kilograms per meter squared (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.

You may not qualify if:

  • Type 1 Diabetes
  • HbA1c equal to or less than 6.5 before randomization or 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 fluid retention or edema
  • History of Heart Failure New York Heart Classification II, III, or IV or acute myocardial infarction or stroke within 2 months of screening
  • Gastrointestinal (GI; stomach) problems such as diabetic gastroparesis or bariatric surgery (stomach stapling) or chronically taking drugs that directly affect GI motility
  • Hepatitis or liver disease or alanine transaminase (ALT) greater than 2.5 times the upper limit of normal
  • 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 creatine 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 (pg/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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (89)

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Goodyear, Arizona, 85395, United States

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Phoenix, Arizona, 85028, United States

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Cathedral City, California, 92234, United States

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Concord, California, 94520, United States

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Fresno, California, 93720, United States

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Greenbrae, California, 94904, United States

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Lancaster, California, 93534, United States

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Mission Hills, California, 91345, United States

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Monterey, California, 93940, United States

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National City, California, 91950, United States

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Oceanside, California, 92056, United States

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Paramount, California, 90723, United States

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Roseville, California, 95661, United States

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San Ramon, California, 94583, United States

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Tustin, California, 92780, United States

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New Britain, Connecticut, 06050, United States

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Fort Lauderdale, Florida, 33316, United States

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Hollywood, Florida, 33021, United States

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Orlando, Florida, 32806, United States

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Pembroke Pines, Florida, 33027, United States

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West Palm Beach, Florida, 33401, United States

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Atlanta, Georgia, 30308, United States

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Honolulu, Hawaii, 96813, United States

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Boise, Idaho, 83702, United States

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Idaho Falls, Idaho, 83404, United States

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Meridian, Idaho, 83646, United States

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Crystal Lake, Illinois, 60012, United States

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Peoria, Illinois, 61615, United States

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Vincennes, Indiana, 47591, United States

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Topeka, Kansas, 66606, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70112, United States

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Bangor, Maine, 04401, United States

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Biddeford, Maine, 04005, United States

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Elkridge, Maryland, 21075, United States

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Bloomfield Hills, Michigan, 48302, United States

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Flint, Michigan, 48503, United States

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St Louis, Missouri, 63141, United States

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Nashua, New Hampshire, 03063, United States

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Toms River, New Jersey, 08753, United States

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Albany, New York, 12206, United States

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Flushing, New York, 11365, United States

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Syracuse, New York, 13210, United States

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Asheville, North Carolina, 28803, United States

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Cary, North Carolina, 27518, United States

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Durham, North Carolina, 27713, United States

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Morehead City, North Carolina, 28557, United States

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Cincinnati, Ohio, 45242, United States

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Cleveland, Ohio, 44122, United States

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Columbus, Ohio, 43210, United States

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Dayton, Ohio, 45439, United States

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Delaware, Ohio, 43015, United States

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Perrysburg, Ohio, 43551, United States

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Bend, Oregon, 97701, United States

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Corvallis, Oregon, 97330, United States

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Eugene, Oregon, 97401, United States

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Beaver, Pennsylvania, 15009, United States

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Danville, Pennsylvania, 17822, United States

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Levittown, Pennsylvania, 19056, United States

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Philadelphia, Pennsylvania, 19107, United States

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Wilkes-Barre, Pennsylvania, 18711, United States

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Charleston, South Carolina, 29412, United States

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Greenville, South Carolina, 29605, United States

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Greer, South Carolina, 29651, United States

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Myrtle Beach, South Carolina, 29572, United States

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Memphis, Tennessee, 38119, United States

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Arlington, Texas, 76014, United States

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Austin, Texas, 78731, United States

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Corpus Christi, Texas, 78404, United States

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Dallas, Texas, 75231, United States

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El Paso, Texas, 79925, United States

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San Antonio, Texas, 78258, United States

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Schertz, Texas, 78154, United States

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Ogden, Utah, 84403, United States

Location

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St. George, Utah, 84790, United States

Location

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West Jordan, Utah, 84088, United States

Location

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Spokane, Washington, 99202, United States

Location

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Tacoma, Washington, 98405, United States

Location

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Buenos Aires, CBA 1419, Argentina

Location

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Guadalajara, 44600, Mexico

Location

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Mexico City, 6700, Mexico

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Monterrey, 64461, Mexico

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Caguas, 00726, Puerto Rico

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Hato Rey, 00917, Puerto Rico

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Manatí, 00674, Puerto Rico

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Ponce, 00716, Puerto Rico

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San Germán, 00683, Puerto Rico

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San Juan, 00907, Puerto Rico

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Yabucoa, 00767, Puerto Rico

Location

Related Publications (3)

  • 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

  • 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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutideExenatideMetforminPioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

PeptidesAmino Acids, Peptides, and ProteinsVenomsComplex MixturesToxins, BiologicalBiological FactorsBiguanidesGuanidinesAmidinesOrganic ChemicalsThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

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
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

February 5, 2010

First Posted

February 8, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2011

Study Completion

May 1, 2012

Last Updated

January 26, 2015

Results First Posted

January 26, 2015

Record last verified: 2015-01

Locations

ME(3)AR(1)US(78)PR(7)