Diabetes interactive cases

Please note, this is a hypothetical patient case made in collaboration with Sanofi and a healthcare expert in the field of endocrinology. It is intended for education only. The patient depicted is fictional. You will follow the patient journey, answer case questions and receive feedback. You will be able to view the aggregated results of how you and others have responded. Individual responses to treatments may vary.


The information contained in this content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition

Diabetes interactive cases

Patient info.

1 54 year-old, diabetic from 18 years

2 Obese (BMI: 32 kg/m2 )

Treatment:

Metformin:1000 mg BID

Sitagliptin:100 mg QD

Glimepiride: 4 mg QD

Insulin glargine 100 U/ml: 42 U QHS

Clinical characteristics: :

Presenting HbA1c: >8.5 % for over 1 year

Target HbA1c: <7 %

FPG:~ 120-140 mg/dL (6.7-7.8 mmol/L)

PPG:~ >250 mg/dL (>13.9 mmol/L)

Diabetes interactive cases

Please choose
an answer below

Diabetes interactive cases

Diabetes interactive cases

For individuals with suboptimally controlled T2D, there are four recommendations for advancing basal insulin therapy1:

Basal Insulin + GLP-1 RA

Basal Insulin + rapid-acting insulin

Multiple doses of premix insulin

Switch to once-daily FRC of basal insulin and GLP-1 RA

Davies MJ et al. Diabetes Care 2022;45(11):2753–2786
Suliqua (iGlarLixi) SmPC available at European Medicines Agency website. Last accessed February 2023.

FRCS allow a single, once-daily injection and may provide a simplified therapy option compared to other alternatives. ¡GlarLixi is a once-daily titratable FRC of basal insulin glargine 100 U/mL (iGlar) and the GLP-1 RA, lixisenatide (Lixi). It combines the complementary actions of these therapies2 : iGlar - primarily targets FPG Lixi - primarily reduces PPG levels FRC of basal insulin and GLP-1 RA

Diabetes interactive cases

If patient with a basal insulin:
  • Fasting blood glucose level
      (usually more than 0.5 units/kg/day)
  • HbA1c (above target)

Diabetes interactive cases

Rapid-acting insulin requires Self management education Self monitoring of glucose levels

Diabetes interactive cases

Increase to complexity & cost Risk of hypoglycemia & weight gain Multiple injections GLP-1 RA + basal insulin analogs (iGlarLixi) Glycemic lowering efficacy Gastrointestinal tolerability Lower rates of hypoglycemia Less weight gain Less treatment complexity and more patient adherence 1. Davies MJ et al. Diabetes Care 2022;45(11):2753–2786 2. Blonde L et al. Curr Med Res Opin. 2019 May;35(5):793-804. 3. Meece J. Diabetes Ther. 2018 Jun;9(3):877-890. 4. Suliqua (iGlarLixi) SmPC available at European Medicines Agency website. Last accessed February 2023. Premixed insulin (Rapid-acting insulin + Basal insulin)

Diabetes interactive cases

Please choose
an answer below

Diabetes interactive cases

Diabetes interactive cases

SoliMix randomized controlled trial
Once daily FRC iGlarLixi demonstrated better glycemic control and weight benefit with less hypoglycemia compared to twice daily premix BIAsp 30. &

Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes: Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial Rosenstock J, Emral R, Sauque-Reyna L, Mohan V, Trescolí C, Al Sifri S, Lalic N, Alvarez A, Picard P, Bonnemaire M, Demil N, McCrimmon RJ, On behalf of the SoliMix Trial Investigators

Study design:
iGlarLixi once daily (n=443) BIAsp 30 twice daily (n=444) vs

Open-label randomized
treatment period (26 weeks)

Inclusion criteria:
Adults with T2D HbA1c ≥ 7.5 - ≤10% Suboptimally controlled by BI plus OADs (metformin+/-) SGLT2 inhibitors
Primary efficacy endpoints:
HbA 1c or Non-interiority of iGlarLixi to BIAsp 30 in HbA1c reduction from baseline to week 26 (margin of 0.3%) Superiority of iGlarLixi to BIAsp 30 in bodyweight change from baseline to week 26
Key secondary endpoints:

Superiority to iGlarLixi versus BIAsp 301:

  1. 1
    The proportion of participants reaching HbA1c target < 7% without weight gain at week 26
  2. 2
    The proportion of participants reaching HbA1c target <7% without weight gain at week 26 and without hypoglycemia (<70 mg/dl) during the treatment period
  3. 3
    HbA1c reduction from baseline to week 26
Conclusion Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia compared with twice-daily premix BIAsp 30. iGlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 for advancing from basal insulin and OAD therapy in people with suboptimally controlled T2D Results: HbA 1c 5 Body weight LS mean ± SE HbA1c, change from baseline to Week 26. % Non-inferiority (achieved) LS mean difference (97.5% CI): -0.2 (-0.4, -0.1) %:p<0.001 Superiority (achieved) LS mean differebnce (95% CI):-1.9 (-2.3, -1.4) Kg; p< 0.001 Superiority (achieved) (key secondary endpoint) Ls mean difference (95% CI): -0.2 (-0.4. -0.1) %; p<0.001 LS mean ± SE bodyweight change from baseline to week 26,Kg +1.2 ±0.2 -1.1 ±0.1 -1.3 ±0.1 -0.7 ±0.2 Other endpoints included incidence and rates of hypoglycemia1 and TEAEs HbA 1c <7 % without weight gain ( Key secondary endpoint ) HbA 1c , <7 % without weight gain and without hypoglycemia (Key secondary endpoint) HbA1c <7% (Exploratory analysis1) P<0.001 P<0.001 0 10 20 30 40 50 Percentage of Participants reaching target 27.5 (n=122) 12.4 (n=56) 19.4 (n=86) 7.0 (n=31) 42.2 (n=187) 31.8(n=141) Hypoglycemia ADA Level 1 ADA Level 2 -45% -55% Relative odds reduction (iGLarLixi vs BIAsp 30) -29% -60% Relative rate reduction (iGLarLixi vs BIAsp 30) Level 3: Hypoglycemic events were infrequent in both treatment groups

1. Rosenstock et al. Diabetes Care. 2021 Jun 28;44(10):2361-2370.

2. Suliqua (iGlarLixi) SmPC available at European Medicines Agency website. Last accessed February 2023.

Diabetes interactive cases

Diabetes interactive cases

Soliqua™ Abbreviated Prescribing Information: KSA

1. Name of the Medicinal Product: SoliquaTM 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen and SoliquaTM 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen. 2. Presentation and Qualitative/Quantitative Composition: SoliquaTM is available in two pens, providing different dosing options, i.e. SoliquaTM (10 - 40) pen, SoliquaTM (30 - 60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen. SoliquaTM 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10 - 40 units of insulin glargine in combination with 5 - 20 mcg lixisenatide (SoliquaTM (10 - 40) pen). SoliquaTM 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30 - 60 units of insulin glargine in combination with 10 -2 0 mcg lixisenatide (SoliquaTM (30 - 60) pen). 3. Therapeutic Indication: SoliquaTM is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. 4. Special Population: Elderly (≥ 65 years old): SoliquaTM can be used in elderly patients. The dose should be adjusted on an individual basis, based on glucose monitoring. Pediatric population: There is no relevant use of SoliquaTM in the pediatric population. 5. Method of Administration SoliquaTM is to be injected subcutaneously in the abdomen, deltoid, or thigh. 6. Contraindications: Hypersensitivity to the active substances or to any of the excipients: Glycerol 85% 20 mg/ml, methionine 3 mg/ml, meta-cresol 2.7 mg/ ml, zinc chloride 0.0626 mg/ml, concentrated hydrochloric acid (for pH adjustment) q.s. pH 4.5, sodium hydroxide (for pH adjustment) q.s. pH 4.5, water for injections q.s. 1 ml. 7. Special Warnings and Precautions for Use: SoliquaTM should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycemia: Hypoglycemia was the most frequently reported observed adverse reaction during treatment with SoliquaTM. Acute pancreatitis: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. Severe gastrointestinal disease: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. SoliquaTM has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of SoliquaTM is not recommended in these patients. Severe renal impairment: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Use is not recommended in patients with severe renal impairment or end-stage renal disease. 8. Pregnancy and Lactation: Women of childbearing potential: SoliquaTM is not recommended in women of childbearing potential not using contraception. Pregnancy: There is no clinical data on exposed pregnancies from controlled clinical studies with use of SoliquaTM, insulin glargine, or lixisenatide. Lactation: SoliquaTM should not be used during breast-feeding. 9. Other Side Effects: Common side effects are feeling dizzy, nausea, vomiting, and diarrhea. Abbreviated Prescribing Information based on SmPC last revised on April 2020. Always refer to full summary of product characteristics SmPC before prescribing.

SOLIQUA™ Abbreviated Prescribing Information: GULF 1.NAME OF THE MEDICINAL PRODUCT: SOLIQUA™ 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen and SOLIQUA™ 100 units/ml + 33 micrograms/ml solution for injection in a pre-filledpen. 2. PRESENTATION AND QUALITATIVE/QUANTITATIVE COMPOSITION: SOLIQUA™ is available in two pens,providing different dosing options, i.e., SOLIQUA™ (10-40) pen, SOLIQUA™ (30-60) pen respectively.The differentiation between the pen strengths is based on the dose range of the pen. SOLIQUA™ 100 units/ml + 50micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine incombination with 5-20 mcg Lixisenatide (SOLIQUA™ (10-40) pen). SOLIQUA™ 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20mcg Lixisenatide (SOLIQUA™ (30-60) pen). 3. THERAPEUTIC INDICATION: SOLIQUA™ is indicated for the treatmentof adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. 4.SPECIAL POPULATION: Elderly (≥65 years old): SOLIQUA™ can be used in elderly patients. The dose should be adjusted on an individual basis, based on glucose monitoring. Paediatric population: There is no relevant use of SOLIQUA™ in the paediatric population.5.METHOD OF ADMINISTRATION: SOLIQUA™ is to be injected subcutaneously in the abdomen, deltoid, or thigh. 6. CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of theexcipients: Glycerol 85%, Methionine, Metacresol, Zinc chloride, Concentrated hydrochloric acid, Sodium hydroxide, Water for injections. Skin changes at the injection site:The injection sites should be rotated within the same region (abdomen, deltoid, or thigh) from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis 7. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Skin changes at the injection site. The injection site should be rotated to prevent skin changes such as lumps under the skin. SOLIQUA™ shouldnot be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycemia: Hypoglycemia was the most frequently reported observed adverse reaction during treatmentwith SOLIQUA™. Acute pancreatitis: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. Severe gastrointestinal disease: Use of GLP-1receptor agonists may be associated with gastrointestinal adverse reactions. SOLIQUA™ has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore,the use of SOLIQUA™ is not recommended in these patients. Severe renal impairment: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min)or end-stage renal disease. Use is not recommended in patients with severe renal impairment or end-stage renal disease 8. PREGNANCY AND LACTATION: Women of childbearing potential: SOLIQUA™ is notrecommended in women of childbearing potential not using contraception. Pregnancy: There is no clinical data on exposed pregnancies from controlled clinical studies with use of SOLIQUA™, insulin glargine, orLixisenatide. Lactation: SOLIQUA™ should not be used during breast-feeding. OTHER SIDE EFFECTS: Common side effects are feeling dizzy, nausea, vomiting and diarrhea. Abbreviated Prescribing Informationbased on SmPC last revised in August 2020. Always refer to full summary of product characteristics SmPC before prescribing.

To report any side effect(s): Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC) SFDA Call Center: 19999 • E-mail: npc.drug@sfda.gov.sa • Website: www.sfda.gov.sa/npc SANOFI, Kingdom of Saudi Arabia, P.O. Box 9874, Jeddah 21423, K.S.A. Tel: +966-12-669-3318, Fax: +966-12-663-6191 For Medical Information, Please contact: +966-12-669-3318, ksa.medicalinformation@sanofi.com For Pharmacovigilance, Please contact: +966-54-428-4797, ksa_pharmacovigilance@sanofi.com To report any Product Technical Complaint, please contact SANOFI Quality Department: Email: KSA_PTC_Reporting@sanofi.com SANOFI, Level 3, One JLT, Jumeirah Lake Towers (JLT), DMCC, PO Box 53899, Dubai, UAE | Tel.: +971 4 550 3600 | Fax: +971 4 5521050 For further medical information, Please contact: For UAE 800 MEDICAL Toll Free Number, For all Gulf Countries +971 565776791 or email: medical-information.gulf@sanofi.com To report an adverse events please call: +971 561747001 or email: Gulf.Pharmacovigilance@sanofi.com

🔊
Diabetes interactive cases

Please note, this is a hypothetical patient case made in collaboration with Sanofi and a healthcare expert in the field of endocrinology. It is intended for education only. The patient depicted is fictional. You will follow the patient journey, answer case questions and receive feedback. You will be able to view the aggregated results of how you and others have responded. Individual responses to treatments may vary.

The information contained in this content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified healthcare provider with any questions you may have regarding a medical condition

🔊
Diabetes interactive cases
Patient info.

1 54 year-old, diabetic from 18 years

2 Obese (BMI: 32 kg/m2 )

Treatment:

Metformin:1000 mg BID

Sitagliptin:100 mg QD

Glimepiride: 4 mg QD

Insulin glargine 100 U/ml: 42 U QHS

Clinical characteristics:

Presenting HbA1c: >8.5 % for over 1 year

Target HbA1c: <7 %

FPG:~ 120-140 mg/dL (6.7-7.8 mmol/L)

PPG:~ >250 mg/dL (>13.9 mmol/L)

🔊
Diabetes interactive cases

Please choose
an answer below

🔊
Diabetes interactive cases
🔊
Diabetes interactive cases

For individuals with suboptimally controlled T2D, there are four recommendations for advancing basal insulin therapy1:

Basal Insulin + GLP-1 RA

Basal Insulin + rapid-acting insulin

Multiple doses of premix insulin

Switch to once-daily FRC of basal insulin and GLP-1 RA

Davies MJ et al. Diabetes Care 2022;45(11):2753–2786
Suliqua (iGlarLixi) SmPC available at European Medicines Agency website. Last accessed February 2023.

FRCS allow a single, once-daily injection and may provide a simplified therapy option compared to other alternatives. ¡GlarLixi is a once-daily titratable FRC of basal insulin glargine 100 U/mL (iGlar) and the GLP-1 RA, lixisenatide (Lixi). It combines the complementary actions of these therapies2 : iGlar - primarily targets FPG Lixi - primarily reduces PPG levels FRC of basal insulin and GLP-1 RA
🔊
Diabetes interactive cases
If patient with a basal insulin:
  • Fasting blood glucose level
      (usually more than 0.5 units/kg/day)
  • HbA1c (above target)
🔊
Diabetes interactive cases
Rapid-acting insulin requires Self management education Self monitoring of glucose levels
🔊
Diabetes interactive cases
Premixed insulin (Rapid-acting insulin + Basal insulin Increase to complexity & cost Risk of hypoglycemia & weight gain Multiple injections GLP-1 RA + basal insulin analogs (iGlarLixi) Glycemic lowering efficacy Gastrointestinal tolerability Lower rates of hypoglycemia Less weight gain Less treatment complexity and more patient adherence 1. Davies MJ et al. Diabetes Care 2022;45(11):2753–2786 2. Blonde L et al. Curr Med Res Opin. 2019 May;35(5):793-804. 3. Meece J. Diabetes Ther. 2018 Jun;9(3):877-890. 4. Suliqua (iGlarLixi) SmPC available at European Medicines Agency website. Last accessed February 2023.
🔊
Diabetes interactive cases

Please choose
an answer below

🔊
Diabetes interactive cases
🔊
Diabetes interactive cases

SoliMix randomized controlled trial

Advancing therapy in suboptimally controlled basal insulin-treated type 2 diabetes: Clinical outcomes with iGlarLixi versus premix BIAsp 30 in the SoliMix randomized controlled trial

Rosenstock J, Emral R, Sauque-Reyna L, Mohan V, Trescolí C, Al Sifri S, Lalic N, Alvarez A, Picard P, Bonnemaire M, Demil N, McCrimmon RJ, On behalf of the SoliMix Trial Investigators

Study design:

1. Rosenstock et al. Diabetes Care. 2021 Jun 28;44(10):2361-2370.

2. Suliqua (iGlarLixi) SmPC available at European Medicines Agency website. Last accessed February 2023.

Conclusion

Once-daily iGlarLixi provided better glycemic control with weight benefit and less hypoglycemia compared with twice-daily premix BIAsp 30. GlarLixi is a more efficacious, simpler, and well-tolerated alternative to premix BIAsp 30 for advancing from basal insulin and OAD therapy in people with suboptimally controlled T2D

🔊
Diabetes interactive cases
🔊
Diabetes interactive cases

Soliqua™ Abbreviated Prescribing Information: KSA

1. Name of the Medicinal Product: SoliquaTM 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen and SoliquaTM 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen. 2. Presentation and Qualitative/Quantitative Composition: SoliquaTM is available in two pens, providing different dosing options, i.e. SoliquaTM (10 - 40) pen, SoliquaTM (30 - 60) pen respectively. The differentiation between the pen strengths is based on the dose range of the pen. SoliquaTM 100 units/ml + 50 micrograms/ml pre-filled pen delivers dose steps from 10 - 40 units of insulin glargine in combination with 5 - 20 mcg lixisenatide (SoliquaTM (10 - 40) pen). SoliquaTM 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30 - 60 units of insulin glargine in combination with 10 -2 0 mcg lixisenatide (SoliquaTM (30 - 60) pen). 3. Therapeutic Indication: SoliquaTM is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. 4. Special Population: Elderly (≥ 65 years old): SoliquaTM can be used in elderly patients. The dose should be adjusted on an individual basis, based on glucose monitoring. Pediatric population: There is no relevant use of SoliquaTM in the pediatric population. 5. Method of Administration SoliquaTM is to be injected subcutaneously in the abdomen, deltoid, or thigh. 6. Contraindications: Hypersensitivity to the active substances or to any of the excipients: Glycerol 85% 20 mg/ml, methionine 3 mg/ml, meta-cresol 2.7 mg/ ml, zinc chloride 0.0626 mg/ml, concentrated hydrochloric acid (for pH adjustment) q.s. pH 4.5, sodium hydroxide (for pH adjustment) q.s. pH 4.5, water for injections q.s. 1 ml. 7. Special Warnings and Precautions for Use: SoliquaTM should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycemia: Hypoglycemia was the most frequently reported observed adverse reaction during treatment with SoliquaTM. Acute pancreatitis: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. Severe gastrointestinal disease: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions. SoliquaTM has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of SoliquaTM is not recommended in these patients. Severe renal impairment: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease. Use is not recommended in patients with severe renal impairment or end-stage renal disease. 8. Pregnancy and Lactation: Women of childbearing potential: SoliquaTM is not recommended in women of childbearing potential not using contraception. Pregnancy: There is no clinical data on exposed pregnancies from controlled clinical studies with use of SoliquaTM, insulin glargine, or lixisenatide. Lactation: SoliquaTM should not be used during breast-feeding. 9. Other Side Effects: Common side effects are feeling dizzy, nausea, vomiting, and diarrhea. Abbreviated Prescribing Information based on SmPC last revised on April 2020. Always refer to full summary of product characteristics SmPC before prescribing.

SOLIQUA™ Abbreviated Prescribing Information: GULF 1.NAME OF THE MEDICINAL PRODUCT: SOLIQUA™ 100 units/ml + 50 micrograms/ml solution for injection in a pre-filled pen and SOLIQUA™ 100 units/ml + 33 micrograms/ml solution for injection in a pre-filledpen. 2. PRESENTATION AND QUALITATIVE/QUANTITATIVE COMPOSITION: SOLIQUA™ is available in two pens,providing different dosing options, i.e., SOLIQUA™ (10-40) pen, SOLIQUA™ (30-60) pen respectively.The differentiation between the pen strengths is based on the dose range of the pen. SOLIQUA™ 100 units/ml + 50micrograms/ml pre-filled pen delivers dose steps from 10-40 units of insulin glargine incombination with 5-20 mcg Lixisenatide (SOLIQUA™ (10-40) pen). SOLIQUA™ 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20mcg Lixisenatide (SOLIQUA™ (30-60) pen). 3. THERAPEUTIC INDICATION: SOLIQUA™ is indicated for the treatmentof adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors. 4.SPECIAL POPULATION: Elderly (≥65 years old): SOLIQUA™ can be used in elderly patients. The dose should be adjusted on an individual basis, based on glucose monitoring. Paediatric population: There is no relevant use of SOLIQUA™ in the paediatric population.5.METHOD OF ADMINISTRATION: SOLIQUA™ is to be injected subcutaneously in the abdomen, deltoid, or thigh. 6. CONTRAINDICATIONS: Hypersensitivity to the active substances or to any of theexcipients: Glycerol 85%, Methionine, Metacresol, Zinc chloride, Concentrated hydrochloric acid, Sodium hydroxide, Water for injections. Skin changes at the injection site:The injection sites should be rotated within the same region (abdomen, deltoid, or thigh) from one injection to the next in order to reduce the risk of lipodystrophy and cutaneous amyloidosis 7. SPECIAL WARNINGS AND PRECAUTIONS FOR USE: Skin changes at the injection site. The injection site should be rotated to prevent skin changes such as lumps under the skin. SOLIQUA™ shouldnot be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Hypoglycemia: Hypoglycemia was the most frequently reported observed adverse reaction during treatmentwith SOLIQUA™. Acute pancreatitis: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis. Severe gastrointestinal disease: Use of GLP-1receptor agonists may be associated with gastrointestinal adverse reactions. SOLIQUA™ has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore,the use of SOLIQUA™ is not recommended in these patients. Severe renal impairment: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min)or end-stage renal disease. Use is not recommended in patients with severe renal impairment or end-stage renal disease 8. PREGNANCY AND LACTATION: Women of childbearing potential: SOLIQUA™ is notrecommended in women of childbearing potential not using contraception. Pregnancy: There is no clinical data on exposed pregnancies from controlled clinical studies with use of SOLIQUA™, insulin glargine, orLixisenatide. Lactation: SOLIQUA™ should not be used during breast-feeding. OTHER SIDE EFFECTS: Common side effects are feeling dizzy, nausea, vomiting and diarrhea. Abbreviated Prescribing Informationbased on SmPC last revised in August 2020. Always refer to full summary of product characteristics SmPC before prescribing.

To report any side effect(s): Saudi Arabia: The National Pharmacovigilance and Drug Safety Centre (NPC) SFDA Call Center: 19999 • E-mail: npc.drug@sfda.gov.sa • Website: www.sfda.gov.sa/npc SANOFI, Kingdom of Saudi Arabia, P.O. Box 9874, Jeddah 21423, K.S.A. Tel: +966-12-669-3318, Fax: +966-12-663-6191 For Medical Information, Please contact: +966-12-669-3318, ksa.medicalinformation@sanofi.com For Pharmacovigilance, Please contact: +966-54-428-4797, ksa_pharmacovigilance@sanofi.com To report any Product Technical Complaint, please contact SANOFI Quality Department: Email: KSA_PTC_Reporting@sanofi.com SANOFI, Level 3, One JLT, Jumeirah Lake Towers (JLT), DMCC, PO Box 53899, Dubai, UAE | Tel.: +971 4 550 3600 | Fax: +971 4 5521050 For further medical information, Please contact: For UAE 800 MEDICAL Toll Free Number, For all Gulf Countries +971 565776791 or email: medical-information.gulf@sanofi.com To report an adverse events please call: +971 561747001 or email: Gulf.Pharmacovigilance@sanofi.com