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A Study of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes Mellitus (AWARD-10)

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Dulaglutide

Placebo

SGLT2 inhibitor

Metformin

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Sites / Locations

Medical Group of Encino
National Research Institute
National Research Institute
New Horizon Research Center
Metabolic Research Institute Inc.
Cotton O'Neil Diabetes and Endocrinology Center
JCMG Clinical Research
Grand Street Medical PC
Diabetes & Endocrinology Consultants PC
PMG Research of Wilmington, LLC
Dallas Diabetes Endocrine Center
Galenos Research
Endeavor Clinical Trials
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Centro de Endocrinologia y Nutricion
Manati Medical Center
Centro de Endocrinologia del Este
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

1.5 mg Dulaglutide

0.75 mg Dulaglutide

Placebo

Arm Description

1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.

0.75 mg dulaglutide given SC once a week for 24 weeks.

Placebo given SC once a week for 24 weeks.

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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

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).

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.

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).

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).

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.

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.

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).

Full Information

NCT ID

NCT02597049

First Posted

November 3, 2015

Last Updated

June 10, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02597049

Brief Title

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

Acronym

AWARD-10

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

424 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1.5 mg Dulaglutide

Arm Type

Experimental

Arm Description

1.5 milligrams (mg) given subcutaneously (SC) once a week for 24 weeks.

Arm Title

0.75 mg Dulaglutide

Arm Type

Experimental

Arm Description

0.75 mg dulaglutide given SC once a week for 24 weeks.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo given SC once a week for 24 weeks.

Intervention Type

Drug

Intervention Name(s)

Dulaglutide

Other Intervention Name(s)

LY2189265

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

SGLT2 inhibitor

Other Intervention Name(s)

Canagliflozin, Dapagliflozin, Empagliflozin

Intervention Description

Administered orally as standard of care for type 2 diabetes

Intervention Type

Drug

Intervention Name(s)

Metformin

Intervention Description

Administered orally as standard of care for type 2 diabetes

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline, Week 24

Title

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

Description

Time Frame

Baseline, Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants With HbA1c <7%

Description

Time Frame

24 Weeks

Title

Change From Baseline in Body Weight at 24 Weeks

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Fasting Serum Glucose (Central Laboratory) at 24 Weeks

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in 6-Point Self-Monitored Plasma Glucose (SMPG) Profile at 24 Weeks

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in Fasting Glucagon at 24 Weeks

Description

Time Frame

Baseline, Week 24

Title

Rate of Hypoglycemic Events Adjusted Per 30 Days

Description

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).

Time Frame

Baseline through 24 Weeks

Title

Number of Participants Requiring Rescue Therapy Due to Severe Persistent Hyperglycemia

Description

Time Frame

Baseline through 24 Weeks

Title

Number of Participants With Adjudicated Acute Pancreatitis Events

Description

Time Frame

Baseline through 24 Weeks

Title

Number of Participants With Adjudicated Cardiovascular (CV) Events

Description

Time Frame

Baseline through 24 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Medical Group of Encino

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

National Research Institute

City

Huntington Park

State/Province

California

ZIP/Postal Code

90255

Country

United States

Facility Name

National Research Institute

City

Los Angeles

State/Province

California

ZIP/Postal Code

90057

Country

United States

Facility Name

New Horizon Research Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Metabolic Research Institute Inc.

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33401

Country

United States

Facility Name

Cotton O'Neil Diabetes and Endocrinology Center

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66606

Country

United States

Facility Name

JCMG Clinical Research

City

Jefferson City

State/Province

Missouri

ZIP/Postal Code

65109

Country

United States

Facility Name

Grand Street Medical PC

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11211

Country

United States

Facility Name

Diabetes & Endocrinology Consultants PC

City

Morehead City

State/Province

North Carolina

ZIP/Postal Code

28557

Country

United States

Facility Name

PMG Research of Wilmington, LLC

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Dallas Diabetes Endocrine Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Galenos Research

City

Dallas

State/Province

Texas

ZIP/Postal Code

75251

Country

United States

Facility Name

Endeavor Clinical Trials

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

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.

City

Saint Stefan Ob Stainz

ZIP/Postal Code

8511

Country

Austria

Facility Name

City

Steyr

ZIP/Postal Code

4400

Country

Austria

Facility Name

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

City

Brandys Nad Labem-Stara Bolesl

ZIP/Postal Code

25001

Country

Czechia

Facility Name

City

Holesov

ZIP/Postal Code

769 01

Country

Czechia

Facility Name

City

Krnov

ZIP/Postal Code

79401

Country

Czechia

Facility Name

City

Pardubice

ZIP/Postal Code

53002

Country

Czechia

Facility Name

City

Praha 4

ZIP/Postal Code

149 00

Country

Czechia

Facility Name

City

Praha 8

ZIP/Postal Code

181 00

Country

Czechia

Facility Name

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

City

Oldenburg

ZIP/Postal Code

23758

Country

Germany

Facility Name

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

City

Budapest

ZIP/Postal Code

1042

Country

Hungary

Facility Name

City

Debrecen

ZIP/Postal Code

4043

Country

Hungary

Facility Name

City

Nagykanizsa

ZIP/Postal Code

8800

Country

Hungary

Facility Name

City

Haifa

ZIP/Postal Code

3299001

Country

Israel

Facility Name

City

Holon

ZIP/Postal Code

5822012

Country

Israel

Facility Name

City

Jerusalem

ZIP/Postal Code

911200

Country

Israel

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64620

Country

Mexico

Facility Name

City

Zapopan

ZIP/Postal Code

45116

Country

Mexico

Facility Name

Centro de Endocrinologia y Nutricion

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

Manati Medical Center

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

Centro de Endocrinologia del Este

City

Yabucoa

ZIP/Postal Code

00767

Country

Puerto Rico

Facility Name

City

Alicante

ZIP/Postal Code

03004

Country

Spain

Facility Name

City

Malaga

ZIP/Postal Code

29006

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41003

Country

Spain

Facility Name

City

Seville

ZIP/Postal Code

41010

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

29483060

Citation

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. Erratum In: Lancet Diabetes Endocrinol. 2018 Jun;6(6):e5.

Results Reference

derived

Learn more about this trial

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

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