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A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

Primary Purpose

Type 2 Diabetes

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Dulaglutide

Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification
Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory
Have been treated with stable doses of metformin for at least 3 months
Have a body mass index (BMI) ≥25 kilograms per square meter

Exclusion Criteria:

Have type 1 diabetes (T1D)
Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past
Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)
Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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
Have had chronic or acute pancreatitis any time prior to study entry
Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation
Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry

Sites / Locations

Parexel Early Phase Unit at Glendale
Marin Endocrine Associates
National Research Institute
National Research Institute
Catalina Research Institute, LLC
Artemis Institute for Clinical Research
Encompass Clinical Research
University Clinical Investigators, Inc.
Infosphere
Diablo Clinical Research
Chase Medical Research, LLC
Axes Medical Research, LLC
Clinical Research of South Florida
East Coast Institute For Research
Suncoast Research Group, LLC
New Horizon Research Center
Palm Harbor Medical Associates
In-Quest Medical Research, LLC - Norcross
East West Medical Institute
Elite Cilnical Trials LLLP
Solaris Clinical Research
HSHS Medical Group Diabetes Research
American Health Network
Iderc, P.L.C.
Cotton O'Neil Diabetes and Endocrinology Center
ActivMed Practices & Research, Inc
StudyMetrix Research, LLC
Manhattan Medical Research
High Point Clinical Trials Center
Aventiv Research
The Corvallis Clinic P.C.
Heritage Valley Medical Group, Inc.
New Phase Research & Development
Dallas Diabetes Endocrine Center
Consano Clinical Research
Clinpoint Trial, LLC
Chrysalis Clinical Research
Rainier Clinical Research Center
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.
Marginal Doctor's Center
American Telemedicine Center
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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Dulaglutide 4.5mg

Dulaglutide 3.0mg

Dulaglutide 1.5mg

Placebo

Arm Description

4.5mg of Dulaglutide administered subcutaneously (SC)

3.0mg of Dulaglutide administered SC

1.5mg of Dulaglutide administered SC

Placebo administered SC

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin A1c (HbA1c)

HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, treatment, time, treatment*time as fixed effects.

Secondary Outcome Measures

Percentage of Participants With HbA1c of <7.0%

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Change From Baseline in Fasting Serum Glucose (FSG)

Fasting serum glucose (FSG) is a test to determine how much glucose (sugar) is in a serum sample after an overnight fast. Least Squares (LS) means was determined by MMRM methodology with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.

Change From Baseline in Body Weight

Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with baseline as a covariate, pooled country, baseline HbA1c strata using >=8% as cutoff, treatment, time, treatment*time as fixed effects.

Percentage of Participants Discontinuing Study Drug Due to Adverse Events

Adverse event (AE) defined as any unfavorable medical event, newly emerged or a deterioration of a preexisting condition, in other words any untoward medical occurrence in a patient administered a pharmaceutical product, without regard to the possibility of a causal relationship, that occurred after the visit for informed consent and up to the visit for completion of administration, or discontinuation.

Rate of Documented Symptomatic Hypoglycemia

Hypoglycemic events (HE) were classified as severe, documented symptomatic (defined as an HE with typical symptoms of hypoglycemia and a blood glucose level of ≤3.9 millimoles per liter [mmol/L]). Hypoglycemia rate per 30 days was summarized at each visit by treatment group. The rate of hypoglycemia was analyzed using a generalized estimation equations model with a negative binomial distribution and a Log link. LS mean was determined by MMRM methodology with baseline hypoglycemia rate, pooled country, HbA1c at Baseline, treatment, with log of exposure in days divided by 365.25 as the offset.

Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide

Plasma samples for PK analysis were combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit. Cmax takes all time points post dose into account and one value was reported.

Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide

AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.

Full Information

NCT ID

NCT02973100

First Posted

November 22, 2016

Last Updated

September 5, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02973100

Brief Title

A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

Official Title

A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

July 15, 2017 (Actual)

Study Completion Date

August 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of investigational doses of dulaglutide in participants with type 2 diabetes on metformin monotherapy.

6. Conditions and Keywords

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

Type 2 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

318 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dulaglutide 4.5mg

Arm Type

Experimental

Arm Description

4.5mg of Dulaglutide administered subcutaneously (SC)

Arm Title

Dulaglutide 3.0mg

Arm Type

Experimental

Arm Description

3.0mg of Dulaglutide administered SC

Arm Title

Dulaglutide 1.5mg

Arm Type

Active Comparator

Arm Description

1.5mg of Dulaglutide administered SC

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC

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

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin A1c (HbA1c)

Description

Time Frame

Baseline, Week 18

Secondary Outcome Measure Information:

Title

Percentage of Participants With HbA1c of <7.0%

Description

Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time.

Time Frame

Week 18

Title

Change From Baseline in Fasting Serum Glucose (FSG)

Description

Time Frame

Baseline, Week 18

Title

Change From Baseline in Body Weight

Description

Time Frame

Baseline, Week 18

Title

Percentage of Participants Discontinuing Study Drug Due to Adverse Events

Description

Time Frame

Baseline through Week 18

Title

Rate of Documented Symptomatic Hypoglycemia

Description

Time Frame

Week 18

Title

Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide

Description

Time Frame

0, 2, 4, 6, 10, 18, 22 weeks and early termination

Title

Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide

Description

AUC[0-168h] is a combined measure obtained from 0, 2, 4, 6, 10, 18, 22 weeks and until early termination of the visit.

Time Frame

0, 2, 4, 6, 10, 18, 22 weeks and early termination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory Have been treated with stable doses of metformin for at least 3 months Have a body mass index (BMI) ≥25 kilograms per square meter Exclusion Criteria: Have type 1 diabetes (T1D) Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke) Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (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 Have had chronic or acute pancreatitis any time prior to study entry Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation Have serum calcitonin ≥20 picograms per milliliter, 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

Parexel Early Phase Unit at Glendale

City

Glendale

State/Province

California

ZIP/Postal Code

91206-4140

Country

United States

Facility Name

Marin Endocrine Associates

City

Greenbrae

State/Province

California

ZIP/Postal Code

94904

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

Catalina Research Institute, LLC

City

Montclair

State/Province

California

ZIP/Postal Code

91763

Country

United States

Facility Name

Artemis Institute for Clinical Research

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

Facility Name

Encompass Clinical Research

City

Spring Valley Lake

State/Province

California

ZIP/Postal Code

91978

Country

United States

Facility Name

University Clinical Investigators, Inc.

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Infosphere

City

Van Nuys

State/Province

California

ZIP/Postal Code

91405

Country

United States

Facility Name

Diablo Clinical Research

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

Chase Medical Research, LLC

City

Waterbury

State/Province

Connecticut

ZIP/Postal Code

06708

Country

United States

Facility Name

Axes Medical Research, LLC

City

Cooper City

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Facility Name

Clinical Research of South Florida

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Facility Name

East Coast Institute For Research

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32204

Country

United States

Facility Name

Suncoast Research Group, LLC

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

New Horizon Research Center

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Facility Name

Palm Harbor Medical Associates

City

Palm Harbor

State/Province

Florida

ZIP/Postal Code

34684

Country

United States

Facility Name

In-Quest Medical Research, LLC - Norcross

City

Norcross

State/Province

Georgia

ZIP/Postal Code

30071

Country

United States

Facility Name

East West Medical Institute

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Elite Cilnical Trials LLLP

City

Blackfoot

State/Province

Idaho

ZIP/Postal Code

83221

Country

United States

Facility Name

Solaris Clinical Research

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83646

Country

United States

Facility Name

HSHS Medical Group Diabetes Research

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62711

Country

United States

Facility Name

American Health Network

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46254

Country

United States

Facility Name

Iderc, P.L.C.

City

Des Moines

State/Province

Iowa

ZIP/Postal Code

50314

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

ActivMed Practices & Research, Inc

City

Methuen

State/Province

Massachusetts

ZIP/Postal Code

01844

Country

United States

Facility Name

StudyMetrix Research, LLC

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63303

Country

United States

Facility Name

Manhattan Medical Research

City

New York Mills

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

High Point Clinical Trials Center

City

High Point

State/Province

North Carolina

ZIP/Postal Code

27265

Country

United States

Facility Name

Aventiv Research

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

The Corvallis Clinic P.C.

City

Corvallis

State/Province

Oregon

ZIP/Postal Code

97330

Country

United States

Facility Name

Heritage Valley Medical Group, Inc.

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15009

Country

United States

Facility Name

New Phase Research & Development

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Dallas Diabetes Endocrine Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75230

Country

United States

Facility Name

Consano Clinical Research

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78231

Country

United States

Facility Name

Clinpoint Trial, LLC

City

Waxahachie

State/Province

Texas

ZIP/Postal Code

75165

Country

United States

Facility Name

Chrysalis Clinical Research

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

Rainier Clinical Research Center

City

Renton

State/Province

Washington

ZIP/Postal Code

98057

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

Brandýs Nad Labem-Stará Boleslav

ZIP/Postal Code

25001

Country

Czechia

Facility Name

City

Krnov

ZIP/Postal Code

79401

Country

Czechia

Facility Name

City

Praha 1

ZIP/Postal Code

11000

Country

Czechia

Facility Name

City

Praha 4 - Krc

ZIP/Postal Code

140 59

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

Chihuahua

ZIP/Postal Code

31217

Country

Mexico

Facility Name

City

Cuernavaca

ZIP/Postal Code

62250

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

04460

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

Tampico

ZIP/Postal Code

89000

Country

Mexico

Facility Name

City

Bialystok

ZIP/Postal Code

15-404

Country

Poland

Facility Name

City

Bialystok

ZIP/Postal Code

15-445

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-333

Country

Poland

Facility Name

City

Lublin

ZIP/Postal Code

20-538

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-655

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-853

Country

Poland

Facility Name

City

Ruda Slaska

ZIP/Postal Code

41-709

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-506

Country

Poland

Facility Name

Marginal Doctor's Center

City

Manati

ZIP/Postal Code

00674

Country

Puerto Rico

Facility Name

American Telemedicine Center

City

San Juan

ZIP/Postal Code

00917

Country

Puerto Rico

Facility Name

City

Alba Iulia

ZIP/Postal Code

510053

Country

Romania

Facility Name

City

Baia Mare

ZIP/Postal Code

430222

Country

Romania

Facility Name

City

Iasi

ZIP/Postal Code

700547

Country

Romania

Facility Name

City

Oradea

ZIP/Postal Code

410159

Country

Romania

Facility Name

City

Satu-Mare

ZIP/Postal Code

440055

Country

Romania

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/

Links:

URL

https://www.lillytrialguide.com/en-US/studies/type-2-diabetes/GBGJ#?postal=

Description

A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

Learn more about this trial

A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

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