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A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes (AWARD-11)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495102
Recruitment Status : Completed
First Posted : April 11, 2018
Results First Posted : June 12, 2020
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Dulaglutide Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1842 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Arm Study of the Efficacy and Safety of Investigational Dulaglutide Doses When Added to Metformin in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : May 28, 2019
Actual Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Dulaglutide 1.5 mg
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Experimental: Dulaglutide 3 mg
Dulaglutide 3 mg administered SC once a week.
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Experimental: Dulaglutide 4.5 mg
Dulaglutide 4.5 mg administered SC once a week.
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265


Outcome Measures
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Primary Outcome Measures :
  1. Change in Hemoglobin A1c (HbA1c) From Baseline [ Time Frame: Baseline, Week 36 ]
    HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. The Least Squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included the independent variables:Baseline + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).


Secondary Outcome Measures :
  1. Change in Body Weight From Baseline [ Time Frame: Baseline, Week 36 ]
    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with independent variables: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

  2. Percentage of Participants Achieving HbA1c Target <7.0% [ Time Frame: Week 36 ]
    Percentage of participants achieving HbA1c target <7.0%.

  3. Change in Fasting Serum Glucose (FSG) From Baseline [ Time Frame: Baseline, Week 36 ]
    Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with covariates: Baseline + Baseline HbA1c group + Pooled Country + Treatment + Time + Treatment*Time (Type III sum of squares).

  4. Rate of Documented Symptomatic Hypoglycemic Episodes [ Time Frame: Week 36 ]
    Hypoglycemia was defined as blood glucose < 54 mg/dL, excluding post-rescue records. Estimate is based on Group Mean from negative binomial model. The negative binomial model for post-baseline comparisons between treatments and control group: Number of episodes = Pooled Country + HbA1c at Baseline (%) + Treatment, with log (exposure in days/365.25) as an offset variable.

  5. Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss) [ Time Frame: Week 4, Week 12, Week 36, Week 52 ]
    Pharmacokinetic (PK): Steady-state Maximum Concentration(Cmax,ss).

  6. Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State [ Time Frame: Week 4, Week 12, Week 36, Week 52 ]
    Pharmacokinetic (PK): Area Under the Curve AUC (0-168)ss at Steady State.


Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have type 2 diabetes mellitus (T2DM) for at least 6 months
  • Have been treated with stable metformin dose for at least 3 months
  • Have HbA1c ≥7.5% and ≤11.0% at study entry
  • Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m^2)

Exclusion Criteria:

  • Have type 1 diabetes mellitus
  • Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
  • Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
  • Have used in the last 3 months (or plan to use) prescription weight loss medications
  • Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
  • Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
  • Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
  • Had chronic or acute pancreatitis any time prior to study entry
  • Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
  • Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73m^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
  • Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
  • Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495102


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] February 5, 2018
Statistical Analysis Plan  [PDF] June 6, 2019

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03495102    
Other Study ID Numbers: 16877
H9X-MC-GBGL ( Other Identifier: Eli Lilly and Company )
2017-003490-33 ( EudraCT Number )
First Posted: April 11, 2018    Key Record Dates
Results First Posted: June 12, 2020
Last Update Posted: June 12, 2020
Last Verified: December 15, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs