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Cardiovascular outcomes with GLP-1 receptor agonists

28 May 2019This document reviews the evidence from the major cardiovascular clinical trials for GLP-1 receptor agonists.
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Refrigerated Storage

TrulicityEli Lilly

Eli Lilly
Trulicity
0.75mg, 1.5mg, 3mg and 4.5mg solution for injection in pre-filled pen

In the event of an inadvertent temperature excursion the following data may be used:

Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30°C.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk
Contact Eli Lilly in all other cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company details.

Reduce expiry to 14 days if exposed to the conditions above
29 September 2021
London MI Service

New Medicines

TrulicityType 2 diabetes mellitus - 3mg and 4.5mg new formulation/dosing regimen

Information

Trulicity
New formulation
Eli Lilly
Eli Lilly

Development and Regulatory status

Launched
Approved (Licensed)
Approved (Licensed)
January 2021
Jan 21Launched in UK. 3m/0.5ml, 4.5mg/0.5ml pen, 4 = £73.25 [8].
Nov 20Trulicity 3mg and 4.35mg pre-filled pen formulations approved in EU for treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise as monotherapy when metformin is considered inappropriate due to intolerance or contraindications, and in addition to other medicinal products for the treatment of diabetes [6].
Sep 20Approved in US [7].
Sep 20EU CHMP issues positive opinion [6].
Jan 20New 3 and 4.5mg formulations under regulatory review; presume EU & US [4].

Category

Long-acting, glucagon-like peptide-1 (GLP-1) analogue - once weekly formulation
Currently 3.8 million people in the UK are diagnosed with diabetes (90% type 2), and it is estimated that a further 1 million people with type 2 diabetes have not yet been diagnosed [1].
Type 2 diabetes mellitus - 3mg and 4.5mg new formulation/dosing regimen
Subcutaneous injection

Trial or other data

Jan 21PIII AWARD-11 trial in 1852 patients with type 2 diabetes inadequately controlled by metformin found dose escalation of dulaglutide from 1.5 mg to 3.0 mg or 4.5 mg once weekly provided improved glycaemic control and body weight reduction vs. 1.5 mg at 36 weeks, with a similar safety [9].
May 20New 36-week data from AWARD-11 trial show HbA1c and weight reduction was greater with 4.5 mg dose (-1.9% and -4.7kg, -1.7% and -4.0 kg, and -1.5% and -3.1kg for 4.5, 3, and 1.5 mg doses respectively) [5].
Jul 19Topline data from AWARD-11 trial showed that the higher dose of Trulicity reached its primary endpoint of significantly reducing HbA1C from baseline vs. a once-a-week dose of Trulicity. At 36 weeks, pts receiving higher doses had better HbA1C reduction and also better weight reduction.[3]
Apr 18PIII AWARD-11 trial to evaluate the safety and efficacy of three doses of once weekly dulaglutide (1.5mg, 3mg and 4.5mg) in patients with type-2 diabetes on metformin starts (NCT03495102). The trial is designed to enrol approximately 1,800 patients in the US, Puerto Rico, Romania, Poland, Mexico, Taiwan, Spain, Slovakia, Russia, Italy, Israel, Hungary, Greece, Canada, Austria and Argentina. Collection of primary outcome data is due to complete May 19 [2].

TrulicityType 2 diabetes mellitus in children aged 10 to 17 years

Information

Trulicity
Licence extension / variation
Eli Lilly
Eli Lilly

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Long-acting, glucagon-like peptide-1 (GLP-1) analogue - once weekly formulation
There are about 31,500 children and young people with diabetes, under the age of 19, in the UK. About 95.1% have T1D, about 1.9% have T2D and 2.73% have maturity-onset diabetes of the young, CF related diabetes or their diagnosis is not defined [1].
Type 2 diabetes mellitus in children aged 10 to 17 years
Subcutaneous injection

Evidence based evaluations