Type 2 Diabetes MellitusPhase 3AWARD-10NCT02597049

A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus

A Phase 3 study testing Dulaglutide, SGLT2 inhibitor and Metformin in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 41 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as dulaglutide when added to sodium-glucose co-transporter 2 (SGLT2) inhibitors in participants with type 2 diabetes mellitus. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus
What is being tested?: Dulaglutide, SGLT2 inhibitor and Metformin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 424 participants
Where: 41 sitesin 9 countries
Study dates: Nov 2015to Feb 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Have type 2 diabetes mellitus (based on the World Health Organization's [WHO] diagnostic criteria)
Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal [GI] intolerability)
Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if:
all prescribed daily doses were in the range between the minimum required dose and maximum-approved dose per country-specific label; and
>90% of prescribed daily doses were equal to the dose at randomization
Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization
Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment

Who cannot join

Have type 1 diabetes mellitus
Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary
Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization
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
Estimated glomerular filtration rate (eGFR) <45 milliliters(mL)/minute/1.73m^2, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead in

Show all 9Show fewer

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 participants with a family history of MEN 2A or 2B, whose family history for the syndrome is rearranged during transfect [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 the 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 picograms/mL as determined by the central laboratory at study entry

Trial locations and contacts

41 sites in 9 countries.

Country

City, postcode or hospital

41 sites in 9 countries

United States13 sites

Grand Street Medical PC
Brooklyn, New York, 11211
Dallas Diabetes Endocrine Center
Dallas, Texas, 75230
Galenos Research
Dallas, Texas, 75251
Medical Group of Encino
Encino, California, 91436
National Research Institute
Huntington Park, California, 90255
JCMG Clinical Research
Jefferson City, Missouri, 65109
National Research Institute
Los Angeles, California, 90057
New Horizon Research Center
Miami, Florida, 33175
Diabetes & Endocrinology Consultants PC
Morehead City, North Carolina, 28557
Endeavor Clinical Trials
San Antonio, Texas, 78229
Cotton O'Neil Diabetes and Endocrinology Center
Topeka, Kansas, 66606
Metabolic Research Institute Inc.
West Palm Beach, Florida, 33401
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401

Other trials in United States

Czechia6 sites

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Brandys Nad Labem-Stara Bolesl, 25001
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Holešov, 769 01
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Krnov, 79401
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Pardubice, 53002
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Prague, 149 00
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Prague, 181 00

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Hungary4 sites

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Budapest, 1023
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Budapest, 1042
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Debrecen, 4043
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Nagykanizsa, 8800

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Spain4 sites

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Alicante, 03004
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Málaga, 29006
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Seville, 41003
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Seville, 41010

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Austria3 sites

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Saint Stefan Ob Stainz, 8511
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Steyr, 4400
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Vienna, 1030

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Israel3 sites

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Haifa, 3299001
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Holon, 5822012
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Jerusalem, 911200

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Mexico3 sites

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Monterrey, 64460
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Monterrey, 64620
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Zapopan, 45116

Other trials in Mexico

Puerto Rico3 sites

Centro de Endocrinologia y Nutricion
Caguas, 00725
Manati Medical Center
Manati, 00674
Centro de Endocrinologia del Este
Yabucoa, 00767

Other trials in Puerto Rico

Germany2 sites

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Münster, 48145
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Oldenburg, 23758

Other trials in Germany

About this study

Official title: A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Conditions: Type 2 Diabetes Mellitus
Being tested: Dulaglutide, Placebo, SGLT2 inhibitor, Metformin
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DulaglutideDrug
Also called LY2189265
Administered SC
PlaceboDrug
Administered SC
SGLT2 inhibitorDrug
Also called Canagliflozin, Dapagliflozin, Empagliflozin
Administered orally as standard of care for type 2 diabetes
MetforminDrug
Administered orally as standard of care for type 2 diabetes

Study groups in NCT02597049
Study group	Role	What they receive
1.5 mg Dulaglutide	Experimental	1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks. Receives: Drug: Dulaglutide; Drug: SGLT2 inhibitor; Drug: Metformin
0.75 mg Dulaglutide	Experimental	0.75 mg dulaglutide given SC once a week for 24 weeks. Receives: Drug: Dulaglutide; Drug: SGLT2 inhibitor; Drug: Metformin
Placebo	Placebo comparator	Placebo given SC once a week for 24 weeks. Receives: Drug: Placebo; Drug: SGLT2 inhibitor; Drug: Metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.
Measured: Baseline, Week 24
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)
LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.
Measured: Baseline, Week 24

Secondary outcomes (9)

Percentage of Participants With HbA1c <7%
Number of participants with an HbA1c value of <7% at Week 24 is measured using longitudinal logistic regression with repeated measurements. The model will include independent variables of treatment, country, SGLT2 inhibitor dose, metformin use, visit, treatment-by-visit interaction, and baseline HbA1c as a covariate.
Measured: 24 Weeks
Change From Baseline in Body Weight at 24 Weeks
LS mean of the body weight change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, treatment-by-visit interactions as fixed effects, and baseline body weight as a covariate and participant as a random effect, via a MMRM analysis
Measured: Baseline, Week 24
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks
LS mean of change from baseline was calculated using last observation carried forward (LOCF) by treatment group, adjusted for treatment, country, SGLT2 inhibitor dose, metformin use, baseline HbA1c strata, and baseline fasting serum glucose using analysis of covariance (ANCOVA).
Measured: Baseline, Week 24
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks
The self-monitored plasma glucose (SMPG) data were collected at the following 6 time points: pre-morning meal; 2 hours post-morning meal; pre-midday meal; 2 hours post-midday meal; pre-evening meal; 2 hours post-evening meal. Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with treatment, metformin use, SGLT2 inhibitor use, country, visit, baseline HbA1c strata, and treatment-by-visit interaction as fixed effects and baseline as a covariate.
Measured: Baseline, Week 24
Change From Baseline in Fasting Glucagon at 24 Weeks
Change from baseline in fasting glucagon was analyzed using an ANCOVA model with last observation carried forward (LOCF) included in treatment, country, SGLT2i dose, metformin use, and baseline HbA1c strata as fixed effects and baseline fasting glucagon as a covariate (with and without post rescue data).
Measured: Baseline, Week 24
Rate of Hypoglycemic Events Adjusted Per 30 Days
A hypoglycemic event is defined as any time a participant feels that he/she is experiencing symptoms and/or signs associated with hypoglycemia, and has a PG level of ≤70 mg/dL (≤3.9 mmol/L).
Measured: Baseline through 24 Weeks
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
Rescue therapy was defined as any additional therapeutic intervention in participants who developed persistent, severe hyperglycemia despite full compliance with the assigned therapeutic regimen, or initiation of an alternative antihyperglycemic medication following study drug discontinuation.
Measured: Baseline through 24 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
The number of participants with events of pancreatitis confirmed by adjudication were summarized cumulatively at 24 weeks. Pancreatitis events were adjudicated by a committee of physicians external to the Sponsor.
A summary of serious and other non-serious events regardless of causality is located in the Reported Adverse Events module.
Measured: Baseline through 24 Weeks
Number of Participants With Adjudicated Cardiovascular (CV) Events
Death and selected nonfatal CV adverse events (AEs) were adjudicated by an independent committee of physicians with cardiology expertise external to the Sponsor. Nonfatal CV events that were to be adjudicated were myocardial infarction (MI); hospitalization for unstable angina; hospitalization for heart failure; coronary interventions such as coronary artery bypass graft (CABG) or ( percutaneous coronary intervention (PCI); and cerebrovascular events, including cerebrovascular accident (stroke) and transient ischemic attack (TIA).
Measured: Baseline through 24 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Feb 2017

First posted4 Nov 2015 (estimated)
Study startNov 2015
Primary completionFeb 2017
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 424 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02597049
Sponsor's protocol ID: 15361
Other IDs: H9X-MC-GBGE, 2015-002095-24, 2015
Acronym: AWARD-10
Status last verified: Jun 2020
First submitted: 3 Nov 2015
Last updated: 17 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: 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.

Publications

Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
PubMed 36894938
Ludvik B, Frias JP, Tinahones FJ, Wainstein J, Jiang H, Robertson KE, Garcia-Perez LE, Woodward DB, Milicevic Z. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 May;6(5):370-381. doi: 10.1016/S2213-8587(18)30023-8. Epub 2018 Feb 23.
PubMed 29483060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Parallel-Arm, Double-Blind Study of Efficacy and Safety of Dulaglutide When Added to SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02597049
Acronym / sponsor ID: AWARD-10 / 15361
Conditions: Type 2 Diabetes Mellitus
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 424 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: Feb 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 4 Nov 2015 (estimated)
Results: Posted 27 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
1.5 mg Dulaglutide	Experimental	Drug: Dulaglutide, Drug: SGLT2 inhibitor, Drug: Metformin1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.
0.75 mg Dulaglutide	Experimental	Drug: Dulaglutide, Drug: SGLT2 inhibitor, Drug: Metformin0.75 mg dulaglutide given SC once a week for 24 weeks.
Placebo	Placebo comparator	Drug: Placebo, Drug: SGLT2 inhibitor, Drug: MetforminPlacebo given SC once a week for 24 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Have type 2 diabetes mellitus (based on the World Health Organization's [WHO] diagnostic criteria)
Have been treated with an SGLT2 inhibitor, with or without metformin, for at least 3 months prior to study entry (minimum required doses for that period for allowed SGLT2 inhibitors: empagliflozin 10 mg, dapagliflozin 5 or 10 mg [per country-specific label], canagliflozin 100 mg); minimum required dose for metformin, if used, is ≥1500 mg/day and must be reached (or highest tolerated dose which is acceptable with documented gastrointestinal [GI] intolerability)
Daily doses of all allowed oral antihyperglycemia agent (OAMs) must have been stable for at least 12 weeks (±3 days) prior to randomization (study enrollment); daily doses of SGLT2 inhibitor and metformin, if used, will be considered stable during this period if:
Have HbA1c ≥7.0% and ≤9.5% at study entry and approximately 1 week prior to randomization
Have body mass index (BMI) ≤45 kilograms per meter squared (kg/m^2) and agree to not initiate a diet and/or exercise program during the study with the intent of reducing body weight other than the lifestyle and dietary measures for diabetes treatment

Key exclusion criteria (9 listed)

Have type 1 diabetes mellitus
Have been treated with any other OAMs (other than SGLT2 inhibitors and metformin), glucagon-like peptide-1 receptor agonist (GLP-1 RA), pramlintide or insulin 3 months prior to study entry, or between study entry and randomization; or initiate metformin between study entry and randomization; short-term use of insulin for acute care (≤14 days) during the 3-month period prior to entry is not exclusionary
Have any condition that is a contraindication for use of the GLP-1 RA class or the SGLT2 inhibitor class (per country-specific labels) at study entry or develop such condition between study entry and randomization
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DulaglutideAlso: LY2189265Administered SC	Drug	0.75 mg Dulaglutide, 1.5 mg Dulaglutide
PlaceboAdministered SC	Drug	Placebo
SGLT2 inhibitorAlso: Canagliflozin, Dapagliflozin, EmpagliflozinAdministered orally as standard of care for type 2 diabetes	Drug	0.75 mg Dulaglutide, 1.5 mg Dulaglutide, Placebo
MetforminAdministered orally as standard of care for type 2 diabetes	Drug	0.75 mg Dulaglutide, 1.5 mg Dulaglutide, Placebo

Primary outcome

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)
Time frame: Baseline, Week 24
Least Squares mean (LS) of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The treatment-regimen estimand used all data including post-rescue data and compared the benefit of treatment regimens as they were actually taken.
Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)
Time frame: Baseline, Week 24
LS mean of the HbA1c change from baseline to primary endpoint at week 24 was adjusted by treatment, country, SGLT2 inhibitor dose, metformin use, treatment-by-visit interactions as fixed effects, and baseline HbA1c as a covariate and participant as a random effect, via a MMRM analysis. The efficacy estimand excluded post-rescue data and compared the benefit of randomized treatments when taken as directed without rescue medication.

9 secondary outcomes

Percentage of Participants With HbA1c <7%
Time frame: 24 Weeks
Change From Baseline in Body Weight at 24 Weeks
Time frame: Baseline, Week 24
Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks
Time frame: Baseline, Week 24
Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks
Time frame: Baseline, Week 24
Change From Baseline in Fasting Glucagon at 24 Weeks
Time frame: Baseline, Week 24
Rate of Hypoglycemic Events Adjusted Per 30 Days
Time frame: Baseline through 24 Weeks
Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia
Time frame: Baseline through 24 Weeks
Number of Participants With Adjudicated Acute Pancreatitis Events
Time frame: Baseline through 24 Weeks
Number of Participants With Adjudicated Cardiovascular (CV) Events
Time frame: Baseline through 24 Weeks

Results and safety

Results posted to the registry on 27 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1.5 mg Dulaglutide	142	135
0.75 mg Dulaglutide	142	137
Placebo	140	137

Primary outcome: Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand)

Time frame: Baseline, Week 24. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	1.5 mg Dulaglutide n = 132	0.75 mg Dulaglutide n = 134	Placebo n = 133
Value	-1.34 (0.064)	-1.21 (0.064)	-0.54 (0.064)

1.5 mg Dulaglutide vs Placebo: Mean Difference (Final Values): -0.79 (95% CI -0.97 to -0.61), p <.001, Mixed Models Analysis
0.75 mg Dulaglutide vs Placebo: Mean Difference (Final Values): -0.66 (95% CI -0.84 to -0.49), p < .001, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of study medication and had evaluable data.

Primary outcome: Change From Baseline in the HbA1c at 24 Weeks (Efficacy Estimand)

Time frame: Baseline, Week 24. Least squares mean (Standard Error). Unit: percentage of HbA1c

Measure	1.5 mg Dulaglutide n = 130	0.75 mg Dulaglutide n = 131	Placebo n = 123
Value	-1.33 (0.063)	-1.19 (0.063)	-0.51 (0.065)

1.5 mg Dulaglutide vs Placebo: Mean Difference (Final Values): -0.82 (95% CI -1.00 to -0.64), p <.001, Mixed Models Analysis
0.75 mg Dulaglutide vs Placebo: Mean Difference (Final Values): -0.69 (95% CI -0.86 to -0.51), p <.001, Mixed Models Analysis

Population analysed: All randomized participants who received at least one dose of study drug and had a baseline and post-baseline value excluding values collected after rescue medication.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of study (up to 24 weeks). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
1.5 mg Dulaglutide	5 of 142 (3.5%)	43 of 142 (30.3%)	2 of 142
0.75 mg Dulaglutide	3 of 141 (2.1%)	34 of 141 (24.1%)	0 of 141
Placebo	5 of 140 (3.6%)	29 of 140 (20.7%)	0 of 140

Limitations and caveats (from the sponsor): One participant was randomized into the study but did not receive study drug. This participant was not included in the efficacy or safety analysis.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36894938Ferdinand KC, Dunn J, Nicolay C, Sam F, Blue EK, Wang H. Weight-dependent and weight-independent effects of dulaglutide on blood pressure in patients with type 2 diabetes. Cardiovasc Diabetol. 2023 Mar 9;22(1):49. doi: 10.1186/s12933-023-01775-x.
Derived from this study: PubMed 29483060Ludvik B, Frias JP, Tinahones FJ, Wainstein J, Jiang H, Robertson KE, Garcia-Perez LE, Woodward DB, Milicevic Z. Dulaglutide as add-on therapy to SGLT2 inhibitors in patients with inadequately controlled type 2 diabetes (AWARD-10): a 24-week, randomised, double-blind, placebo-controlled trial. Lancet Diabetes Endocrinol. 2018 May;6(5):370-381. doi: 10.1016/S2213-8587(18)30023-8. Epub 2018 Feb 23.
Click here for more information about this study: A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes MellitusLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

41 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dulaglutide, SGLT2 inhibitor and Metformin in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 41 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, Czechia, Hungary, Spain, Austria and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) at 24 Weeks (Treatment-regimen Estimand) (time frame: Baseline, Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02597049, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.