A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes (AWARD-6)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01624259
First received: June 18, 2012
Last updated: January 7, 2014
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Drug: Dulaglutide
Drug: Liraglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Parallel-Arm Study Comparing the Effect of Once-Weekly Dulaglutide With Once-Daily Liraglutide in Patients With Type 2 Diabetes (AWARD-6: Assessment of Weekly AdministRation of LY2189265 in Diabetes-6)

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Body Weight at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Body Mass Index (BMI) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Fasting Plasma Glucose at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in 7-Point Self Monitored Plasma Glucose (SMPG) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Achieve HbA1c ≤6.5% and <7% at 26 Weeks [ Time Frame: 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Homeostasis Model Assessment 2 steady-state Beta (β)- cell function (HOMA2-%B) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Reported and Adjudicated Cardiovascular Events [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Electrocardiogram (ECG) Parameters at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Heart Rate (HR) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Blood Pressure (BP) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Adjudicated Acute Pancreatitis Events [ Time Frame: Baseline up to 30 Weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline in Calcitonin at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Lipase at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants with Self Reported Events of Hypoglycemia [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Percentage of Participants Requiring Additional Intervention for Severe, Persistent Hyperglycemia [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Time to Initiation of Additional Intervention for Severe, Persistent Hyperglycemia [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Number of Participants with Allergic or Hypersensitivity Reactions [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Dulaglutide Anti-Drug Antibodies [ Time Frame: Baseline up to 4 Weeks Post Last Dose of Study Drug ] [ Designated as safety issue: Yes ]
  • Rate of Hypoglycemic Events Adjusted per 30 Days [ Time Frame: Baseline through 26 Weeks ] [ Designated as safety issue: No ]
  • Change from Baseline in Amylase at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 592
Study Start Date: June 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dulaglutide
Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 26 weeks added to the participant's pre-study prescribed metformin dose.
Drug: Dulaglutide
Administered SQ
Other Name: LY2189265
Active Comparator: Liraglutide
Liraglutide 0.6 mg, administered SQ once daily for 7 days then titrate up to Liraglutide 1.2 mg SQ once daily for 7 days then titrate up to Liraglutide 1.8 mg SQ once daily for 24 weeks added to the participant's pre-study prescribed metformin dose.
Drug: Liraglutide
Administered SQ

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • HbA1c value of ≥7.0% to ≤10.0%
  • Accept continued treatment with metformin throughout the trial, as required per protocol
  • Men and nonpregnant women aged ≥18 years
  • Stable weight (±5%) ≥3 months prior to screening
  • Body Mass Index (BMI) ≤45 kilograms/square meter (kg/m^2)

Exclusion Criteria:

  • 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 (>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 (CV) 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 (eg, 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 ≥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 ≥1.5 milligram/deciliter (mg/dL) (male) or ≥1.4 mg/dL (female), or a creatinine clearance <60 milliliter/minute (mL/minute)
  • Have any self or family history of type 2A or type 2B multiple endocrine neoplasia (MEN 2A or 2B) in the absence of known C-cell hyperplasia (this exclusion includes those participants with a family history of MEN 2A or 2B, whose family history for the syndrome is Rearranged during Transfection (RET) negative; the only exception for this exclusion will be for participants whose family members with MEN 2A or 2B have a known RET mutation and the potential participant for the study is negative for that RET mutation)
  • Have any self or family history of medullary C-cell hyperplasia, focal hyperplasia, carcinoma (including sporadic, familial or part of MEN 2A or 2B syndrome)
  • Have a serum calcitonin ≥20 picogram/milliliter (pg/mL)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01624259

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Locations
United States, Arizona
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Phoenix, Arizona, United States, 85027
United States, California
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Chino, California, United States, 91710
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Fresno, California, United States, 93720
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Los Angeles, California, United States, 90057
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Spring Valley, California, United States, 91978
United States, Florida
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Fort Lauderdale, Florida, United States, 33316
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Miami, Florida, United States, 33175
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Oviedo, Florida, United States, 32765
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Louisville, Kentucky, United States, 40218
United States, Louisiana
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Shreveport, Louisiana, United States, 71101
United States, Michigan
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Royal Oak, Michigan, United States, 48073
United States, Nevada
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Las Vegas, Nevada, United States, 89119
United States, Ohio
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Perrysburg, Ohio, United States, 43551
United States, Tennessee
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Kingsport, Tennessee, United States, 37660
United States, Texas
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Dallas, Texas, United States, 75230
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Hurst, Texas, United States, 76054
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San Antonio, Texas, United States, 78228
Czech Republic
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Prague, Czech Republic, 181 00
Germany
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Dresden, Germany, 01307
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Hohenmölsen, Germany, 06679
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Lingen, Germany, 49808
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Mainz, Germany, 55116
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Neunkirchen, Germany, 66539
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St. Ingbert-Oberwürzbach, Germany, 66386
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Sulzbach, Germany, 92237
Hungary
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Budapest, Hungary, H-1139
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Debrecen, Hungary, 4043
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Dombovar, Hungary, 7200
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Szekesfehervar, Hungary, 8000
Mexico
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Monterrey, Mexico, 64620
Poland
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Bialystok, Poland, 15-445
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Gdansk, Poland, 80-546
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Kamieniec Zabkowicki, Poland, 57-230
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Lodz, Poland, 90-242
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Poznan, Poland, 61-853
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Ruda Slaska, Poland, 41-709
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Szczecin, Poland, 70-506
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Tychy, Poland, 43-100
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Wroclaw, Poland, 50-306
Puerto Rico
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Hato Rey, Puerto Rico, 00917
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Rio Grande, Puerto Rico, 00745
Romania
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Bucharest, Romania, 020045
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Galati, Romania, 800098
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Ploiesti, Romania, 100342
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Sibiu, Romania, 550371
Slovakia
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Kosice, Slovakia, 04012
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Malacky, Slovakia, 90101
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Nitra, Slovakia, 94901
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Nove Mesto Nad Vahom, Slovakia, 91501
Spain
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Alcira, Spain, 46600
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Alicante, Spain, 03114
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Barcelona, Spain, 08022
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Centelles, Spain, 08540
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Málaga, Spain, 29006
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Palma De Mallorca, Spain, 07014
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Petrer, Spain, 03610
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01624259     History of Changes
Other Study ID Numbers: 11377, H9X-MC-GBDE, 2011-003810-18
Study First Received: June 18, 2012
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on September 16, 2014