Dulaglutide

Generic Name: Dulaglutide

Brand Names: Trulicity

Drug Type: Biotech

CAS Number: 923950-08-7

Unique Ingredient Identifier: WTT295HSY5

Background: Dulaglutide, marketed by Eli Lilly as Trulicity, is a once-weekly subcutaneous glucagon-like peptide-1 (GLP-1) receptor agonist designed using recombinant DNA technology; it has been approved as an adjunct therapy to diet and exercise in the management of 2 diabetes (T2DM). Dulaglutide was initially approved by the FDA in 2014, and in February 2020 was approved for use in patients with T2DM and multiple cardiovascular risk factors for the prevention of cardiovascular events. It is the first T2DM drug approved to reduce major adverse cardiovascular events (MACE) risk in primary and secondary prevention populations.

Indication: Dulaglutide is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients ≥10 years of age with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.

Associated Conditions: Major Adverse Cardiovascular Events, Type 2 Diabetes Mellitus

Clinical Trials

A Study Comparing the Effects and Safety of Dulaglutide With Glimepiride in Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Dulaglutide
Drug: Glimepiride
Drug: Placebo as Capsules
Drug: Placebo as SC Injection

First Posted Date: 2012-07-19

Last Posted Date: 2019-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 737

Registration Number: NCT01644500

Locations: 🇨🇳
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., Yong Kung City, Taiwan

A Study Comparing the Effect of Dulaglutide With Liraglutide in Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: LY2189265
Drug: Liraglutide
Drug: Metformin

First Posted Date: 2012-06-20

Last Posted Date: 2014-10-09

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 599

Registration Number: NCT01624259

Locations: 🇪🇸
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., Petrer, Spain

A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)

Phase 3

Completed

Conditions: Type 2 Diabetes
Chronic Kidney Disease

Interventions: Drug: Insulin glargine
Drug: Dulaglutide
Drug: Insulin lispro

First Posted Date: 2012-06-18

Last Posted Date: 2019-09-19

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 577

Registration Number: NCT01621178

Locations: 🇺🇸
Academic Medical Research Institute, Los Angeles, California, United States
🇺🇸
Extended Arm Physician, Inc., Montgomery, Alabama, United States
🇺🇸
Infosphere, West Hills, California, United States

and more 44 locations

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: LY2189265
Drug: Insulin glargine
Drug: Sulfonylureas (SU)
Drug: Biguanide (BG)

First Posted Date: 2012-04-24

Last Posted Date: 2014-10-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 361

Registration Number: NCT01584232

Locations: 🇯🇵
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., Yamaguchi, Japan

A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: LY2189265
Drug: Liraglutide
Drug: Placebo

First Posted Date: 2012-03-20

Last Posted Date: 2015-05-22

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 492

Registration Number: NCT01558271

Locations: 🇯🇵
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., Yokohama, Japan

A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: LY2189265
Drug: Thiazolidinedione (TZD)
Drug: alpha-glucosidase inhibitor (a-GI)
Drug: Glinides
Drug: Biguanides (BG)
Drug: Sulfonylureas (SU)

First Posted Date: 2011-11-09

Last Posted Date: 2015-01-29

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 394

Registration Number: NCT01468181

Locations: 🇯🇵
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., Wakayama, Japan

Researching Cardiovascular Events With a Weekly Incretin in Diabetes (REWIND)

Phase 3

Completed

Conditions: Cardiovascular Disease
Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Dulaglutide

First Posted Date: 2011-07-15

Last Posted Date: 2019-10-08

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 9901

Registration Number: NCT01394952

Locations: 🇬🇧
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., Londonderry, United Kingdom

A Single Dose Study of LY2189265 in Subjects With Varying Degrees of Hepatic (Liver) Impairment

Phase 1

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: LY2189265

First Posted Date: 2010-12-03

Last Posted Date: 2014-10-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 26

Registration Number: NCT01253304

Locations: 🇭🇺
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., Budapest, Hungary

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-4)

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: LY2189265
Drug: Insulin Glargine
Drug: Insulin Lispro

First Posted Date: 2010-08-30

Last Posted Date: 2014-10-08

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 884

Registration Number: NCT01191268

Locations: 🇨🇳
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., Yong Kang City, Taiwan

A Study of the Effect of LY2189265 on Blood Pressure and Heart Rate in Type 2 Diabetes

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: LY2189265

First Posted Date: 2010-06-23

Last Posted Date: 2015-02-02

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 755

Registration Number: NCT01149421

Locations: 🇵🇷
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., Santurce, Puerto Rico

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