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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

A Study in Participants With Type 2 Diabetes Mellitus (AWARD-3)

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo (oral)
Drug: Placebo (subcutaneous)
First Posted Date
2010-05-19
Last Posted Date
2015-01-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
807
Registration Number
NCT01126580
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., Nottingham, United Kingdom

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

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-02-25
Last Posted Date
2015-01-16
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
810
Registration Number
NCT01075282
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., Yung-Kang, Tainan, Taiwan

A Study in Participants With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
First Posted Date
2010-02-08
Last Posted Date
2015-01-26
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
978
Registration Number
NCT01064687
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., Yabucoa, Puerto Rico

A Study of LY2189265 in Japanese Patients With Type 2 Diabetes

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo
First Posted Date
2009-10-23
Last Posted Date
2015-09-28
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
145
Registration Number
NCT01001104
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., Tokyo, Japan

A Study of LY2189265 Compared to Sitagliptin in Participants With Type 2 Diabetes Mellitus on Metformin

Phase 2
Completed
Conditions
Diabetes Mellitus, Type 2
Interventions
Drug: Placebo tablet
Drug: Placebo solution
First Posted Date
2008-08-14
Last Posted Date
2015-04-20
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
1202
Registration Number
NCT00734474
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., Yung-Kang, Tainan, Taiwan

A Study of Dose Titration of LY2189265 in Overweight Participants With Type 2 Diabetes Mellitus

Phase 2
Completed
Conditions
Diabetes Mellitus Type 2
Interventions
Drug: Placebo
First Posted Date
2008-03-07
Last Posted Date
2014-12-10
Lead Sponsor
Eli Lilly and Company
Target Recruit Count
262
Registration Number
NCT00630825
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., Toa Baja, Puerto Rico

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