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

Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC) Versus GLP-1 Receptor Agonist in Patients With Type 2 Diabetes, With a FRC Extension Period

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: liraglutide
Drug: Insulin glargine/lixisenatide fixed ratio combination
Drug: exenatide
Drug: exenatide extended-release
Drug: albiglutide
Drug: dulaglutide

First Posted Date: 2016-06-01

Last Posted Date: 2022-03-25

Lead Sponsor: Sanofi

Target Recruit Count: 514

Registration Number: NCT02787551

Locations: 🇺🇸
Investigational Site Number 8400033, Baltimore, Maryland, United States
🇺🇸
Investigational Site Number 8400079, Albany, New York, United States
🇺🇸
Investigational Site Number 8400019, Columbus, Ohio, United States

and more 121 locations

Effects of GLP-1 Analogues on Fluid Intake in Patients With Primary Polydipsia (The GOLD-Study)

Phase 2

Completed

Conditions: Primary Polydipsia

Interventions: Drug: Dulaglutide
Drug: Placebo

First Posted Date: 2016-05-12

Last Posted Date: 2020-01-18

Lead Sponsor: University Hospital, Basel, Switzerland

Target Recruit Count: 50

Registration Number: NCT02770885

Locations: 🇨🇭
University Hospital Basel, Basel, Switzerland

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Phase 1

Completed

Conditions: Healthy
Type 2 Diabetes Mellitus (T2DM)

Interventions: Drug: Placebo
Drug: Tirzepatide
Drug: Dulaglutide

First Posted Date: 2016-05-03

Last Posted Date: 2024-01-16

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 142

Registration Number: NCT02759107

Locations: 🇸🇬
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician., Singapore, Singapore
🇺🇸
Miami Research Associates, South Miami, Florida, United States

A Study of Dulaglutide in Japanese Participants With Type 2 Diabetes

Phase 4

Completed

Conditions: Type 2 Diabetes

Interventions: Drug: Dulaglutide
Drug: Placebo

First Posted Date: 2016-04-25

Last Posted Date: 2019-09-24

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 159

Registration Number: NCT02750410

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, Tama, Japan
🇯🇵
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

Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.

Phase 3

Completed

Conditions: Diabetes
Diabetes Mellitus, Type 2

Interventions: Drug: Dulaglutide
Drug: semaglutide

First Posted Date: 2016-01-06

Last Posted Date: 2019-10-15

Lead Sponsor: Novo Nordisk A/S

Target Recruit Count: 1201

Registration Number: NCT02648204

Locations: 🇬🇧
Novo Nordisk Investigational Site, Watford, United Kingdom

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

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Dulaglutide
Drug: Placebo
Drug: SGLT2 inhibitor
Drug: Metformin

First Posted Date: 2015-11-04

Last Posted Date: 2020-06-17

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 424

Registration Number: NCT02597049

Locations: 🇵🇷
Manati Medical Center, Manati, Puerto Rico
🇺🇸
Grand Street Medical PC, Brooklyn, New York, United States
🇺🇸
PMG Research of Wilmington, LLC, Wilmington, North Carolina, United States

and more 14 locations

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

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Placebo
Drug: Dulaglutide
Drug: Insulin Glargine
Drug: Metformin

First Posted Date: 2014-06-02

Last Posted Date: 2019-09-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 300

Registration Number: NCT02152371

Locations: 🇺🇸
Valley Endocrine, Fresno, Fresno, California, United States
🇺🇸
Northwest Endo Diabetes Research, LLC, Arlington Heights, Illinois, United States
🇺🇸
Mills-Peninsula Diabetes Research Insitute, San Mateo, California, United States

and more 17 locations

Study of How Dulaglutide Compares to Placebo in Participants With Type 2 Diabetes Who Are Also on Sulfonylurea Therapy (AWARD-8)

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Placebo
Drug: Dulaglutide
Drug: Glimepiride

First Posted Date: 2013-01-16

Last Posted Date: 2016-01-25

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 300

Registration Number: NCT01769378

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., Somerset West, South Africa

A Study of Dulaglutide in Chinese Participants

Phase 1

Completed

Conditions: Diabetes Mellitus, Type 2
Healthy Volunteers

Interventions: Drug: Dulaglutide
Drug: Placebo

First Posted Date: 2012-08-17

Last Posted Date: 2016-03-07

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 58

Registration Number: NCT01667900

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., Beijing, China

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

Phase 3

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: Dulaglutide
Drug: Insulin glargine
Drug: Metformin
Drug: Sulfonylureas

First Posted Date: 2012-07-24

Last Posted Date: 2019-09-18

Lead Sponsor: Eli Lilly and Company

Target Recruit Count: 774

Registration Number: NCT01648582

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., Sankt-Petersburg, Russian Federation

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