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

June 18, 2012
January 7, 2014
June 2012
November 2013   (final data collection date for primary outcome measure)
Change from Baseline in Glycosylated Hemoglobin A1c (HbA1c) at 26 Weeks [ Time Frame: Baseline, 26 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01624259 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes
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)

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • Drug: Dulaglutide
    Administered SQ
    Other Name: LY2189265
  • Drug: Liraglutide
    Administered SQ
  • 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.
    Intervention: Drug: Dulaglutide
  • 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.
    Intervention: Drug: Liraglutide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
592
November 2013
November 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Germany,   Hungary,   Mexico,   Poland,   Puerto Rico,   Romania,   Slovakia,   Spain
 
NCT01624259
11377, H9X-MC-GBDE, 2011-003810-18
No
Eli Lilly and Company
Eli Lilly and Company
Not Provided
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
Eli Lilly and Company
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP