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

Phase 3
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, week 12, week 36, week 52
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
No Placebo-Only Group

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.

Eligible Conditions
  • Diabetes
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, week 12, week 36, week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, week 12, week 36, week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Hemoglobin A1c (HbA1c) From Baseline
Secondary study objectives
Change in Body Weight From Baseline
Change in Fasting Serum Glucose (FSG) From Baseline
Percentage of Participants Achieving HbA1c Target <7.0%
+3 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Dulaglutide 4.5 mgExperimental Treatment1 Intervention
Dulaglutide 4.5 mg administered SC once a week.
Group II: Dulaglutide 3 mgExperimental Treatment1 Intervention
Dulaglutide 3 mg administered SC once a week.
Group III: Dulaglutide 1.5 mgActive Control1 Intervention
Dulaglutide 1.5 mg administered subcutaneously (SC) once a week.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dulaglutide
FDA approved

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,464,542 Total Patients Enrolled
11 Trials studying Diabetes
15,748 Patients Enrolled for Diabetes
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
426,999 Total Patients Enrolled
3 Trials studying Diabetes
4,457 Patients Enrolled for Diabetes
~240 spots leftby Jan 2026
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