Soliqua and Trulicity Comparison

Soliqua®(insulin glargine / lixisenatide)	Trulicity®(dulaglutide)
Prescription Only Soliqua 100/33 is a combination medication featuring insulin glargine and lixisenatide. Insulin glargine offers prolonged blood glucose reduction, while lixisenatide enhances...	Prescription Only Trulicity is an injectable medication designed to manage blood sugar levels in individuals with diabetes. It is employed in conjunction with dietary adjustments and physical...
Administration
Subcutaneous. Learn more.	Subcutaneous. Learn more.
Dosing
Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.	Adults * 0.75 mg injected SC weekly. * ↑ 1.5 mg once weekly for glycemic control* ↑ 1.5 mg increments after at least 4 weeks * Max 4.5 mg weekly. Pediatric * 0.75 mg injected SC weekly. * ↑ to max 1.5 mg weekly after at least 4 weeks on the 0.75 mg.. Learn more.
Latin Shorthand
Administer SOLIQUA 100/33 SC qd within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.	Adults: Start: 0.75 mg SC weekly ↑ to 1.5 mg weekly for more control ↑ by 1.5 mg every 4 wks if needed Max: 4.5 mg weekly Pediatric: Start: 0.75 mg SC weekly ↑ to 1.5 mg weekly if more control needed after 4 wks at 0.75 mg. Learn more.
Out-Of-Pocket Costs With Copay Card
$9. Learn more.	$25. Learn more.
Annual Cap
$365 per pack. Learn more.	$1800. Learn more.
Assistance Expiration
12 months. Learn more.	End of calendar year. Learn more.
Generics
No lower-cost generic available	No lower-cost generic available
Adverse Reactions
The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.. Learn more.	Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.. Learn more.
Mechanism of Actions (MoA)
GLP-1 Receptor Agonists. Learn more.	GLP-1 Receptor Agonists. Learn more.
Special Populations
1. What are the pregnancy risks associated with SOLIQUA 100/33? Based on animal studies, there may be fetal risks from exposure to lixisenatide during pregnancy. SOLIQUA 100/33 should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Limited data are available, and there is no clear association with major birth defects or miscarriage risk. 2. What is the risk of major birth defects and miscarriage in pregnant women with diabetes? The estimated background risk of major birth defects is 6%–10% in women with pregestational diabetes and HbA1c >7, and it can be as high as 20%–25% with HbA1c >10. The background risk of miscarriage for this population is unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage is 2%–4% and 15%–20%, respectively. 3. What are the maternal and fetal risks associated with poorly controlled diabetes during pregnancy? Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. The fetal risk includes major birth defects, stillbirth, and macrosomia-related morbidity. 4. What fetal risks are associated with lixisenatide exposure during pregnancy? Lixisenatide exposure in pregnant rats and rabbits was associated with visceral closure and skeletal defects. These effects were observed at exposures higher than the highest clinical dose. Decreases in maternal food intake and weight gain were also observed. However, the relevance of these findings to human risk assessment is confounded by concurrent maternal effects. 5. Is there any information about lixisenatide and insulin glargine in human milk? There is no information about the presence of lixisenatide and insulin glargine in human milk, their effects on the breastfed infant, or their effects on milk production. Lixisenatide is present in rat milk. 6. Is SOLIQUA 100/33 safe and effective for pediatric patients? Safety and effectiveness of SOLIQUA 100/33 have not been established in pediatric patients. 7. What should be considered for geriatric patients using SOLIQUA 100/33? While no overall differences in effectiveness and safety were observed in geriatric patients, caution should be exercised. In elderly patients with diabetes, dosing should be conservative to avoid hypoglycemic reactions, as hypoglycemia may be difficult to recognize in the elderly. 8. What are the considerations for patients with renal impairment using SOLIQUA 100/33? Frequent glucose monitoring and dose adjustment may be necessary for SOLIQUA 100/33 in patients with renal impairment. Patients with severe renal impairment should be closely monitored for adverse reactions and changes in renal function. 9. How does hepatic impairment affect the use of SOLIQUA 100/33? The effect of hepatic impairment on the pharmacokinetics of SOLIQUA 100/33 has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for patients with hepatic impairment. 10. Can SOLIQUA 100/33 be used in patients with gastroparesis? SOLIQUA 100/33 is not recommended for patients with severe gastroparesis. Lixisenatide, a component of SOLIQUA 100/33, slows gastric emptying.	What are the pregnancy-related risks associated with TRULICITY use? Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see Clinical Considerations]. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. TRULICITY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide. What is the estimated background risk of major birth defects and miscarriage in women with pre-gestational diabetes? The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. What are the clinical considerations regarding pregnancy and TRULICITY use? Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. What animal data is available regarding TRULICITY use during pregnancy? Pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (AUC) comparison. Reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. Irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg. In pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the MRHD, based on plasma AUC comparison. Fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. In a prenatal-postnatal study in F0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the MRHD, based on plasma AUC comparison. F1 pups from F0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. F1 offspring from F0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. Females had decreased startle response. These physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. F1 female offspring of the F0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the Biel water maze. These findings occurred in conjunction with decreased F0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. The human relevance of these memory deficits in the F1 female rats is not known. What are the risks associated with TRULICITY use during lactation? There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The presence of dulaglutide in milk of treated lactating animals was not determined. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRULICITY and any potential adverse effects on the breastfed infant from TRULICITY or from the underlying maternal condition. Is TRULICITY safe and effective for pediatric use? The safety and effectiveness of TRULICITY as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. Use of TRULICITY for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see Clinical Studies (14.6)]. TRULICITY-treated pediatric patients reported a higher incidence of injection site-related reactions compared to TRULICITY-treated adults. The safety and effectiveness of TRULICITY have not been established in pediatric patients less than 10 years of age. What is the experience with TRULICITY use in geriatric patients? In the adult glycemic control trials [see Clinical Studies (14.2, 14.3)], 620 (19%) of TRULICITY-treated patients were 65 years of age or older and 65 (2%) of TRULICITY-treated patients were 75 years of age or older at baseline. In the TRULICITY 1.5 mg treatment arm of the REWIND trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors), 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline. No overall differences in safety or effectiveness for TRULICITY have been observed between patients 65 years of age and older and younger adult patients. Is dosage adjustment necessary for patients with renal impairment using TRULICITY? TRULICITY has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. No overall differences in safety or effectiveness were observed in these studies according to renal function. In a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. In the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the PK behavior of TRULICITY 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies. No dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Use TRULICITY with caution in patients with ESRD. Is dosage adjustment necessary for patients with hepatic impairment using TRULICITY? In a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide PK was observed. However, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use TRULICITY with caution in these patient populations. What precautions should be taken for patients with gastroparesis using TRULICITY? Dulaglutide slows gastric emptying. TRULICITY has not been studied in patients with preexisting gastroparesis. Use TRULICITY with caution in patients with gastroparesis.

Soliqua®(insulin glargine / lixisenatide)

Trulicity®(dulaglutide)

Prescription Only

Soliqua 100/33 is a combination medication featuring insulin glargine and lixisenatide. Insulin glargine offers prolonged blood glucose reduction, while lixisenatide enhances...

Prescription Only

Trulicity is an injectable medication designed to manage blood sugar levels in individuals with diabetes. It is employed in conjunction with dietary adjustments and physical...

Dosage & Administration

Administration

Subcutaneous. Learn more.

Dosing

Administer SOLIQUA 100/33 subcutaneously once a day within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.

Adults * 0.75 mg injected SC weekly. * ↑ 1.5 mg once weekly for glycemic control* ↑ 1.5 mg increments after at least 4 weeks * Max 4.5 mg weekly. Pediatric * 0.75 mg injected SC weekly. * ↑ to max 1.5 mg weekly after at least 4 weeks on the 0.75 mg.. Learn more.

Latin Shorthand

Administer SOLIQUA 100/33 SC qd within the hour prior to the first meal of the day. See starting dose and titration table in the PI for schedule.. Learn more.

Adults: Start: 0.75 mg SC weekly ↑ to 1.5 mg weekly for more control ↑ by 1.5 mg every 4 wks if needed Max: 4.5 mg weekly Pediatric: Start: 0.75 mg SC weekly ↑ to 1.5 mg weekly if more control needed after 4 wks at 0.75 mg. Learn more.

Financial Assistance

Out-Of-Pocket Costs With Copay Card

$9. Learn more.

$25. Learn more.

Annual Cap

$365 per pack. Learn more.

$1800. Learn more.

Assistance Expiration

12 months. Learn more.

End of calendar year. Learn more.

Generics

No lower-cost generic available

Physician Advisory

Adverse Reactions

The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.. Learn more.

Most common adverse reactions (incidence ≥5%) are nausea, diarrhea, vomiting, abdominal pain, and decreased appetite.. Learn more.

Mechanism of Actions (MoA)

GLP-1 Receptor Agonists. Learn more.

Special Populations

1. What are the pregnancy risks associated with SOLIQUA 100/33?

Based on animal studies, there may be fetal risks from exposure to lixisenatide during pregnancy. SOLIQUA 100/33 should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Limited data are available, and there is no clear association with major birth defects or miscarriage risk.

2. What is the risk of major birth defects and miscarriage in pregnant women with diabetes?

The estimated background risk of major birth defects is 6%–10% in women with pregestational diabetes and HbA1c >7, and it can be as high as 20%–25% with HbA1c >10. The background risk of miscarriage for this population is unknown. In the general U.S. population, the estimated background risk of major birth defects and miscarriage is 2%–4% and 15%–20%, respectively.

3. What are the maternal and fetal risks associated with poorly controlled diabetes during pregnancy?

Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. The fetal risk includes major birth defects, stillbirth, and macrosomia-related morbidity.

4. What fetal risks are associated with lixisenatide exposure during pregnancy?

Lixisenatide exposure in pregnant rats and rabbits was associated with visceral closure and skeletal defects. These effects were observed at exposures higher than the highest clinical dose. Decreases in maternal food intake and weight gain were also observed. However, the relevance of these findings to human risk assessment is confounded by concurrent maternal effects.

5. Is there any information about lixisenatide and insulin glargine in human milk?

There is no information about the presence of lixisenatide and insulin glargine in human milk, their effects on the breastfed infant, or their effects on milk production. Lixisenatide is present in rat milk.

6. Is SOLIQUA 100/33 safe and effective for pediatric patients?

Safety and effectiveness of SOLIQUA 100/33 have not been established in pediatric patients.

7. What should be considered for geriatric patients using SOLIQUA 100/33?

While no overall differences in effectiveness and safety were observed in geriatric patients, caution should be exercised. In elderly patients with diabetes, dosing should be conservative to avoid hypoglycemic reactions, as hypoglycemia may be difficult to recognize in the elderly.

8. What are the considerations for patients with renal impairment using SOLIQUA 100/33?

Frequent glucose monitoring and dose adjustment may be necessary for SOLIQUA 100/33 in patients with renal impairment. Patients with severe renal impairment should be closely monitored for adverse reactions and changes in renal function.

9. How does hepatic impairment affect the use of SOLIQUA 100/33?

The effect of hepatic impairment on the pharmacokinetics of SOLIQUA 100/33 has not been studied. Frequent glucose monitoring and dose adjustment may be necessary for patients with hepatic impairment.

10. Can SOLIQUA 100/33 be used in patients with gastroparesis?

SOLIQUA 100/33 is not recommended for patients with severe gastroparesis. Lixisenatide, a component of SOLIQUA 100/33, slows gastric emptying.

What are the pregnancy-related risks associated with TRULICITY use?

Limited data with TRULICITY in pregnant women are not sufficient to determine a drug-associated risk for major birth defects and miscarriage. There are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see Clinical Considerations]. Based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. TRULICITY should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week. In pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the MRHD. Adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide.

What is the estimated background risk of major birth defects and miscarriage in women with pre-gestational diabetes?

The estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an HbA1c >7% and has been reported to be as high as 20–25% in women with an HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively.

What are the clinical considerations regarding pregnancy and TRULICITY use?

Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity.

What animal data is available regarding TRULICITY use during pregnancy?

Pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (MRHD) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (AUC) comparison. Reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. Irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg. In pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the MRHD, based on plasma AUC comparison. Fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. In a prenatal-postnatal study in F0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the MRHD, based on plasma AUC comparison. F1 pups from F0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. F1 offspring from F0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. Females had decreased startle response. These physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. F1 female offspring of the F0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the Biel water maze. These findings occurred in conjunction with decreased F0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. The human relevance of these memory deficits in the F1 female rats is not known.

What are the risks associated with TRULICITY use during lactation?

There are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. The presence of dulaglutide in milk of treated lactating animals was not determined. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TRULICITY and any potential adverse effects on the breastfed infant from TRULICITY or from the underlying maternal condition.

Is TRULICITY safe and effective for pediatric use?

The safety and effectiveness of TRULICITY as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. Use of TRULICITY for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see Clinical Studies (14.6)]. TRULICITY-treated pediatric patients reported a higher incidence of injection site-related reactions compared to TRULICITY-treated adults. The safety and effectiveness of TRULICITY have not been established in pediatric patients less than 10 years of age.

What is the experience with TRULICITY use in geriatric patients?

In the adult glycemic control trials [see Clinical Studies (14.2, 14.3)], 620 (19%) of TRULICITY-treated patients were 65 years of age or older and 65 (2%) of TRULICITY-treated patients were 75 years of age or older at baseline. In the TRULICITY 1.5 mg treatment arm of the REWIND trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors), 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline. No overall differences in safety or effectiveness for TRULICITY have been observed between patients 65 years of age and older and younger adult patients.

Is dosage adjustment necessary for patients with renal impairment using TRULICITY?

TRULICITY has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. No overall differences in safety or effectiveness were observed in these studies according to renal function. In a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (ESRD), no clinically relevant change in dulaglutide pharmacokinetics (PK) was observed. In the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the PK behavior of TRULICITY 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies. No dose adjustment is recommended in patients with renal impairment including end-stage renal disease (ESRD). Monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. Use TRULICITY with caution in patients with ESRD.

Is dosage adjustment necessary for patients with hepatic impairment using TRULICITY?

In a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide PK was observed. However, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use TRULICITY with caution in these patient populations.

What precautions should be taken for patients with gastroparesis using TRULICITY?

Dulaglutide slows gastric emptying. TRULICITY has not been studied in patients with preexisting gastroparesis. Use TRULICITY with caution in patients with gastroparesis.

Soliqua® Alternatives