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Trulicity ® (dulaglutide)
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Can Trulicity® (dulaglutide) be used in patients with concomitant renal impairment?
No dose adjustment is required in mild, moderate, or severe renal impairment (eGFR < 90 to ≥ 15 mL/min/1.73 m2). Dulaglutide can’t be recommended in patients with end stage renal disease (eGFR < 15 mL/min/1.73 m2).
Content overview
Is there a minimum recommended eGFR for dulaglutide?
Patients should have an estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73m2. Dulaglutide can't be recommended in patients with an eGFR < 15 mL/min/1.73m2.1
Efficacy and safety of dulaglutide in patients with varying levels of baseline kidney function
The use of glucagon-like peptide-1 receptor agonists, like dulaglutide, is associated with gastrointestinal adverse reactions, which include nausea, vomiting, and diarrhea. These events may lead to dehydration, which could cause a worsening in renal function and acute renal failure.2
We evaluated the safety and efficacy of dulaglutide in patients with varying levels of baseline kidney function in AWARD-11, AWARD-7, and a clinical pharmacology study. Overall, the kidney function did not systematically influence the efficacy, safety or pharmacokinetic parameters of dulaglutide.2
Efficacy and safety of dulaglutide 0.75 mg and 1.5 mg in AWARD-7
AWARD-7 compared the efficacy and safety of once-weekly dulaglutide 1.5 mg or 0.75 mg with insulin glargine, all in combination with insulin lispro, for the treatment of patients with type 2 diabetes and moderate-to-severe chronic kidney disease (CKD). It was phase 3, randomized, multicenter, open-label (blinded for the dose of dulaglutide), and took 52-weeks.3
The AWARD-7 study showed that dulaglutide has similar efficacy and safety compared with insulin glargine in patients with CKD.3
Please find the baseline eGFR and duration of CKD for patients in AWARD-7 in .3
Parametera |
Dulaglutide 1.5 mg |
Dulaglutide 0.75 mg |
Insulin Glargine |
Duration of CKDb, y |
4.2 (5.6) |
4.0 (4.9) |
3.5 (4.0) |
eGFR by creatinine, mL/min/1.73m2c |
35.7 (1.0) |
36.2 (0.9) |
36.1 (0.9) |
≥60 to <90, n (%) |
9 (5) |
7 (4) |
14 (7) |
≥45 to <60, n (%) |
53 (28) |
53 (28) |
51 (26) |
≥30 to <45, n (%) |
73 (38) |
75 (39) |
67 (35) |
≥15 to <30, n (%) |
55 (29) |
55 (29) |
61 (31) |
<15, n (%) |
2 (1) |
0 (0) |
1 (1) |
Abbreviations: AWARD = Assessment of Weekly AdministRation of LY2189265 in Diabetes; CKD = chronic kidney disease; eGFR = estimated glomerular filtration rate.
aData presented as mean (SD) unless otherwise indicated and based on safety population, defined as all patients who received ≥1 dose of study treatment and had post dose data.
bStage 3 or higher at baseline.
cGeometric mean (SE).
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Efficacy and safety of dulaglutide 1.5 mg, 3.0 mg and 4.5 mg in AWARD-11
A post hoc analysis of AWARD-11 evaluated the safety and efficacy of dulaglutide 1.5 mg, 3.0 mg, and 4.5 mg in patients with different baseline renal function and inadequately controlled type 2 diabetes on concomitant metformin therapy.4 AWARD-11 was a phase 3, randomized, double-blind, active-controlled, parallel-arm study.5
We categorized patients into 3 subgroups by baseline estimated glomerular filtration rate (eGFR)
- ≥90 mL/min/1.73 m2
- ≥60 to <90 mL/min/1.73 m2, and
- ≥30 to <60 mL/min/1.73 m2.4
Patients with an eGFR less than 30 mL/min/1.73 m2 were excluded from AWARD-11. We have no safety or efficacy data for dulaglutide 3.0 mg or dulaglutide 4.5 mg in this population.2
The effect of dulaglutide 1.5 mg, 3.0 mg, or 4.5 mg on glycated haemoglobin (HbA1c) from baseline to week 52 was not significantly affected by the baseline eGFR (interaction p value = 0.128).4
Similarly, the incidence of common treatment-emergent adverse events was not influenced by the baseline eGFR (interaction p value > 0.10 for all events, ).4
Safety Outcomes According to Renal Function Levela |
Dulaglutide 1.5 mg |
Dulaglutide 3.0 mg |
Dulaglutide 4.5 mg |
Test for Different Treatment Effects Across Renal Function Subgroup (P value)b |
Number of Patients With Events, n/N (%) |
||||
Gastrointestinal eventsc |
0.657 |
|||
Baseline eGFR ≥90 |
87/408 (21.3) |
99/393 (25.2) |
111/397 (28.0) |
|
60≤ baseline eGFR <90 |
35/171 (20.5) |
52/198 (26.3) |
50/184 (27.2) |
|
30≤ baseline eGFR <60 |
6/33 (18.2) |
3/25 (12.0) |
10/33 (30.3) |
|
Hypoglycemiad |
0.188 |
|||
Baseline eGFR ≥90 |
6/408 (1.5) |
0/393 (0.0) |
4/397 (1.0) |
|
60≤ baseline eGFR <90 |
3/171 (1.8) |
2/198 (1.0) |
3/184 (1.6) |
|
30≤ baseline eGFR <60 |
0/33 (0.0) |
0/25 (0.0) |
0/33 (0.0) |
|
Incidence of new-onset albuminuriae |
0.236 |
|||
Baseline eGFR ≥90 |
23/408 (5.6) |
18/393 (4.6) |
23/397 (5.8) |
|
60≤ baseline eGFR <90 |
9/171 (5.3) |
7/198 (3.5) |
16/184 (8.7) |
|
30≤ baseline eGFR <60 |
2/33 (6.1) |
5/25 (20.0) |
4/33 (12.1) |
|
Incidence of new-onset macroalbuminuriaf |
0.827 |
|||
Baseline eGFR ≥90 |
7/408 (1.7) |
3/393 (0.8) |
7/397 (1.8) |
|
60≤ baseline eGFR <90 |
4/171 (2.3) |
1/198 (0.5) |
3/184 (1.6) |
|
30≤ baseline eGFR <60 |
2/33 (6.1) |
0/25 (0.0) |
1/33 (3.0) |
Abbreviations: Cr = creatinine; eGFR = estimated glomerular filtration rate; TEAE = treatment-emergent adverse event; UACR = urine albumin-to-creatinine ratio.
aRenal function level as measured by eGFR using cystatin C equation (in mL/min/1.73 m2).
bP value for test of homogeneity of odds ratios in treatment groups and renal subgroups is from a Breslow Day test.
cIncluded nausea, vomiting, and diarrhea.
dDefined as plasma glucose <3 mmol/L (54 mg/dL).
eDevelopment of UACR >3.39 mg/mmol (30 mg/g Cr).
fDevelopment of UACR >33.9 mg/mmol (300 mg/g Cr).
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Pharmacokinetic parameters of dulaglutide in a clinical pharmacology study
We noted no clinically relevant changes in the pharmacokinetic parameters of dulaglutide in a phase 1, pharmacokinetic study that evaluated a single dose of dulaglutide 1.5 mg in patients with mild, moderate, and severe renal impairment (n=32), including end-stage renal disease (ESRD).2,6
Please find the baseline characteristics in .2
Parametera |
Control |
Mild Impairment |
Moderate Impairment |
Severe Impairment |
ESRDb |
T2D, % |
0.0 |
12.5 |
0.0 |
12.5 |
0.0 |
Estimated CrCl, mL/min |
89.9 (10.7) |
55.7 (4.19) |
39.3 (6.56) |
25.8 (2.45) |
10.3 (1.77) |
Abbreviations: CrCl = creatinine clearance; ESRD = end-stage renal disease; FDA = Food and Drug Administration; T2D = type 2 diabetes.
aData presented as mean (SD) unless otherwise noted.
bAll 8 people in the ESRD group were undergoing dialysis, as defined in the FDA 1998 Guidance, which was used to assign subjects to this renal function group.
Can dulaglutide be used in dialysis patients with end-stage renal disease?
We did not systematically evaluate the safety and efficacy of dulaglutide in patients with type 2 diabetes on dialysis. There is very limited experience in patients with end-stage renal disease (<15 mL/min/1.73 m2), therefore dulaglutide cannot be recommended in this population.1
Can dulaglutide be used after renal transplant or nephrectomy?
We didn't evaluate dulaglutide in patients with a history of renal transplant or nephrectomy, therefore, we have no safety or efficacy data for this population.2
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References
1Trulicity [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Tuttle KR, Lakshmanan MC, Rayner B, et al. Dulaglutide versus insulin glargine in patients with type 2 diabetes and moderate-to-severe chronic kidney disease (AWARD-7): a multicentre, open-label, randomised trial. Lancet Diabetes Endocrinol. 2018;6(8):605-617. https://doi.org/10.1016/S2213-8587(18)30104-9
4Garcia-Perez LE, Maldonado JM, Ranta KT, Raha S. Effect of once weekly dulaglutide 3.0 mg and 4.5 mg in patients with different baseline renal function: post-hoc analysis from the AWARD-11 Trial. Poster presented at: 81st Scientific Sessions of the American Diabetes Association (ADA 2021 Virtual); June 25-29, 2021. Accessed May 13, 2022. https://ada.scientificposters.com/apprizr.cfm?IQCczPZNd9gXuFgj0kBfYZsprbX4rdRzY%2B8cb5%2B73SR1434uxecFQn6LboNBPEjXX%2Fh7kQapqEU%3D
5Frias JP, Bonora E, Nevarez Ruiz L, et al. Efficacy and safety of dulaglutide 3.0 mg and 4.5 mg versus dulaglutide 1.5 mg in metformin-treated patients with type 2 diabetes in a randomized controlled trial (AWARD-11). Diabetes Care. 2021;44(3):765-773. https://doi.org/10.2337/dc20-1473
6Loghin C, de la Peña A, Cui X, et al. Pharmacokinetics of once weekly dulaglutide in special populations. Diabetes. 2014;63(suppl 1):A251. American Diabetes Association abstract 980-P. https://doi.org/10.2337/db14-833-1316
7Dungan KM, Povedano ST, Forst T, et al. Once-weekly dulaglutide versus once-daily liraglutide in metformin-treated patients with type 2 diabetes (AWARD-6): a randomised, open-label, phase 3, non-inferiority trial. Lancet. 2014;384(9951):1349-1357. https://doi.org/10.1016/S0140-6736(14)60976-4
8Dungan KM, Weitgasser R, Perez Manghi F, et al. A 24-week study to evaluate the efficacy and safety of once-weekly dulaglutide added on to glimepiride in type 2 diabetes (AWARD-8). Diabetes Obes Metab. 2016;18(5):475-482. http://dx.doi.org/10.1111/dom.12634
9Gerstein HC, Colhoun HM, Dagenais GR, et al; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019;394(10193):121-130. https://doi.org/10.1016/S0140-6736(19)31149-3
Date of Last Review: 13 April 2022