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 of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Dulaglutide

First Posted Date: 2018-04-11

Last Posted Date: 2020-06-12

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 1842

Registration Number: NCT03495102

Locations: 🇺🇸
Artemis Institute for Clinical Research, San Diego, California, United States
🇺🇸
University Clinical Investigators, Inc., Tustin, California, United States
🇺🇸
Saltzer Medical Group. P.A., Nampa, Idaho, United States

and more 203 locations

Effect of Exenatide LAR or Dulaglutide on the Variability of 24-hour Heart Rate and Blood Pressure in Type 2 Diabetes

Phase 4

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Exenatide LAR
Drug: Dulaglutide

First Posted Date: 2018-02-23

Last Posted Date: 2020-03-26

Lead Sponsor: University of Guadalajara

Target Recruit Count: 30

Registration Number: NCT03444142

Locations: 🇲🇽
Instituto de terapeutica Experimental y Clinica. Centro universitario de Ciencias de la Salud. Universidad de Guadalajara, Guadalajara, Jalisco, Mexico

A Study of Dulaglutide in Healthy Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Dulaglutide (Reference)
Drug: Dulaglutide (Test)

First Posted Date: 2017-12-06

Last Posted Date: 2019-07-29

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 27

Registration Number: NCT03363906

Locations: 🇺🇸
Covance Dallas, Dallas, Texas, United States

A Study of the Glucodynamic Effects of Dulaglutide (LY2189265) in Japanese Participants With Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Dulaglutide
Drug: Placebo

First Posted Date: 2017-10-20

Last Posted Date: 2019-09-16

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 12

Registration Number: NCT03315780

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., Fukuoka, Japan

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues

Phase 2

Completed

Conditions: Smoking Cessation
Weight Change, Body
Glucagon-like Peptide-1
Craving

Interventions: Drug: 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])
Drug: Dulaglutide

First Posted Date: 2017-07-02

Last Posted Date: 2022-09-13

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 256

Registration Number: NCT03204396

Locations: 🇨🇭
Universitätsspital Basel, Basel, Switzerland

Effects of Glucagon Like Peptide 1 (GLP-1) Analogues on Fluid Intake

Phase 2

Completed

Conditions: Thirst
Water-Electrolyte Imbalance

Interventions: Other: Placebo
Drug: Dulaglutide

First Posted Date: 2017-05-05

Last Posted Date: 2017-10-25

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 17

Registration Number: NCT03141632

Locations: 🇨🇭
University Hospital Basel, Basel, Switzerland

A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Mellitus

Phase 2

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: tirzepatide
Drug: Dulaglutide
Drug: Placebo

First Posted Date: 2017-04-27

Last Posted Date: 2019-08-20

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 318

Registration Number: NCT03131687

Locations: 🇸🇰
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician., Trenčín, Slovakia
🇸🇰
"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.", Trenčín, Slovakia
🇺🇸
National Research Institute, Los Angeles, California, United States

and more 38 locations

Safety and Efficacy of Oral Semaglutide Versus Dulaglutide Both in Combination With One OAD (Oral Antidiabetic Drug) in Japanese Subjects With Type 2 Diabetes

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: Dulaglutide
Drug: Semaglutide

First Posted Date: 2017-01-09

Last Posted Date: 2021-03-02

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 458

Registration Number: NCT03015220

Locations: 🇯🇵
Novo Nordisk Investigational Site, Yamato-shi, Kanagawa, Japan

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

Phase 2

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Placebo
Drug: Dulaglutide

First Posted Date: 2016-11-25

Last Posted Date: 2019-09-23

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 318

Registration Number: NCT02973100

Locations: 🇺🇸
Parexel Early Phase Unit at Glendale, Glendale, California, United States
🇺🇸
Marin Endocrine Associates, Greenbrae, California, United States
🇺🇸
Catalina Research Institute, LLC, Montclair, California, United States

and more 37 locations

A Study of Dulaglutide (LY2189265) in Children and Adolescents With Type 2 Diabetes

Phase 3

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Dulaglutide
Drug: Placebo

First Posted Date: 2016-11-15

Last Posted Date: 2022-07-01

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 154

Registration Number: NCT02963766

Locations: 🇺🇸
ECU Pediatric Specialty Care, Greenville, North Carolina, United States
🇺🇸
Pennington Biomedical Research Center, Baton Rouge, Louisiana, United States
🇺🇸
Division of Endocrinology, Diabetes, and Metabolism, Los Angeles, California, United States

and more 58 locations

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