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

  Show 57 Study Locations
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014