Efficacy



Soliqua compared to Basal-Plus / Basal-Bolus

PSM study design⁴

For adult patients with type 2 diabetes struggling to control glycaemia with basal insulin

 

SOLIQUA™ significantly reduced HbA1c in once daily injection compared to basal bolus⁴

 

SOLIQUA™ significantly associated with more patients reaching target HbA1c without hypoglycemia and weight gain vs basal-bolus therapy⁴

 

Patients reaching
HbA1c <7 without hypo

Patients reaching HbA1c <7 without hypo & no weight gain

 

SOLIQUA™ was significantly associated with twice as many patients reaching target HbA1c without weight gain⁴

    1. Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care 2016; 39: 2026–2035.
    2. Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, González-Gálvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes care. 2016; 39(11):1972-80. 
    3. SOLIQUA™ SmPC as of July 2020. 
    4. Tabak AG, Anderson G, Aschner P, et al. Efficacy and Safety of iGlarLixi, Fixed-Ratio Combination of Insulin Glargine and Lixisenatide, Compared with Basal-Bolus Regimen in Patients with Type 2 Diabetes: Propensity Score Matched Analysis. Diabetes Ther 2020; 11:305–318.

Soliqua compared to PreMix Insulin

 

Safety and efficacy of SOLIQUA™ and IDegAsp in type 2 diabetes patients not controlled on basal insulin indirect comparison¹

 

SOLIQUA™ significantly helped more patients to achieve HbA1c target with better HbA1c reduction compared to IDegAsp¹

HbA1c (%) decrease
from baseline*

Proportion of patients achieving glycemic control**

* ETD 0.53% (95% CI 0.27;-0.79, p<0.0001).

** OR 0.40 (95% CI -0.083;0.884, p<0.0001).

 

SOLIQUA™ has favorable weight benefit & less hypoglycemia compared to IDegAsp¹

SOLIQUA decreased
weight from baseline*

Fewer patients on SOLIQUA reported hypoglycemia events**

* ETD 1.73 ± 0.32 (95% CI 1.09-2.47, p<0.0001).

** OR=1.33 (95% CI 0.859;1.797, p<0.001).

    1. Jammah AA. Indirect comparison of efficacy and safety of insulin glargine/lixisenatide and insulin degludec/insulin aspart in type 2 diabetes patients not controlled on basal insulin. Primary Care Diabetes. 2020: 1-6.
    2. Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, González-Gálvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes care. 2016 ;39(11):1972-80.
    3. Kumar S, Jang HC, Demirağ NG, Skjøth TV, Endahl L, Bode B. Efficacy and safety of once-daily insulin degludec/insulin aspart compared with once-daily insulin glargine in participants with Type 2 diabetes: a randomized, treat-to-target study. Diabetic Medicine. 2017; 34(2):180-8.

SoliMix Study



Glycemic Control

SOLIQUA™ achieved superior HbA1c reduction compared to premix insulin1

REDUCTION IN HbA1c AT BASELINE TO WEEK 26

 

Analyses of primary and key secondary efficacy endpoints were performed using the intent-to-treat population.

*Adults who have been treated with any basal insulin combined with 1 or 2 OADs that could be metformin alone or metformin + an SGLT2 inhibitor.1,2

Non-inferiority p-value was calculated using a non-inferiority margin of 0.3%.

CI = confidence interval LS = least squares

OADs = oral antidiabetic drugs

SGLT2 = sodium-glucose cotransporter-2 T2D = type 2 diabetes

At Week 26, mean HbA1c improved to 7.3% for the SOLIQUA™ group vs 7.5% for the premix insulin group, both from mean baselines of 8.6%

    1. Rosenstock J, Emral R, Sauque-Reyna L, et al. Diabetes Care. Published online June 28, 2021.
    2. McCrimmon RJ, Al Sifri S, Emral R, et al. Diabetes Obes Metab. 2021:1-11. Epub ahead of print. PMID: 33606908. doi:10.1111/dom.14354

SOLIQUA™ significantly helped more patients to achieve HbA1c target with better HbA1c reduction compared to IDegAsp¹

HbA1c (%) decrease
from baseline*

Proportion of patients achieving glycemic control**

* ETD 0.53% (95% CI 0.27;-0.79, p<0.0001).

** OR 0.40 (95% CI -0.083;0.884, p<0.0001).

    1. Jammah AA. Indirect comparison of efficacy and safety of insulin glargine/lixisenatide and insulin degludec/insulin aspart in type 2 diabetes patients not controlled on basal insulin. Primary Care Diabetes. 2020: 1-6.

     

Favorable Hypoglycemia Profile

 

Lower incidence of hypoglycemia was observed with SOLIQUA™ compared to premix insulin1†

Overall safety and tolerability profiles of SOLIQUA™ and premix insulin were consistent with the known safety profile of each product. Gastrointestinal (GI) disorders were more common in the SOLIQUA™ group vs premix insulin: nausea 7.7% vs 0.0%, vomiting 1.1% vs 0.2%, and dyspepsia 0.9% vs 0.2%,2 respectively

*Adults who have been treated with any basal insulin combined with 1 or 2 OADs that could be metformin alone or metformin + an SGLT2 inhibitor.1,3

Severe hypoglycaemia, defined as severe cognitive impairment requiring external assistance, was rare with only 1 episode occurring in the SOLIQUA™ group and 2 episodes in the premix insulin group.

The higher incidence of AEs observed for SOLIQUA™ vs premix insulin was due to nausea and led to treatment discontinuation in 0.5% of patients. Over the 26-week treatment period, 32.6 % of SOLIQUA™ patients and 27.7% of premix insulin patients reported treatment-emergent adverse events; 2.7% vs 2.9%, respectively, reported serious adverse events. The rate of discontinuation due to any adverse event was 0.9% for each group.

ADA = American Diabetes Association OADs = oral antidiabetic drugs

PG = plasma glucose

PPY = per participant-year

SGLT2 = sodium-glucose cotransporter-2 T2D = type 2 diabetes

The odds ratios (95% CI) for the risk reduction in incidence of hypoglycemia for SOLIQUA™ vs premix insulin was 0.62 (0.47, 0.81) any event; 0.55 (0.42, 0.74) level 1; and 0.45 (0.28, 0.73) level 2.1

    1. Rosenstock J, Emral R, Sauque-Reyna L, et al. Diabetes Care. Published online June 28, 2021.
    2. DoF 15017 study results.
    3. McCrimmon RJ, Al Sifri S, Emral R, et al. Diabetes Obes Metab. 2021:1-11. Epub ahead of print. PMID: 33606908. doi:10.1111/dom.14354

     

No increased risk of hypoglycemia despite significant HbA1c reduction1

Superiority of SOLIQUA vs. basal insulin in patients with HbA1c >9%

Lower hypo events
with SOLIQUA

    1. Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, González-Gálvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes care. 2016; 39(11):1972-80.
    2. Niemoeller E, Souhami E, Wu Y, and Jensen KH. iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes Ther 2018; 9: 373–382.

Weight Change Superiority


SOLIQUA™ achieved superior weight change compared to premix insulin1

Mean baseline weight (+/- SD) was 80.7 kg +/- 16.5 kg for SOLIQUA™ vs 82.2 kg +/- 18.5 kg for premix insulin.

*Adults who have been treated with any basal insulin combined with 1 or 2 OADs that could be metformin alone or metformin + an SGLT2 inhibitor.1,2

CI = confidence interval

LS = least squares

OADs = oral antidiabetic drugs SD = standard deviation

SGLT2 = sodium-glucose cotransporter-2 T2D = type 2 diabetes

    1. Rosenstock J, Emral R, Sauque-Reyna L, et al. Diabetes Care. Published online June 28, 2021.
    2. McCrimmon RJ, Al Sifri S, Emral R, et al. Diabetes Obes Metab. 2021:1-11. Epub ahead of print. PMID: 33606908. doi:10.1111/dom.14354

No weight gain¹

 

More patients achieve HbA1c target without weight gain²

     

    1. Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care 2016; 39: 2026–2035.
    2. Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, González-Gálvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes care. 2016; 39(11):1972-80.

Read Full SoliMix Study Outcomes


Complete Profile




Shedding light to Soliqua Profile



HBA1C reduction1,2

SOLIQUA™ significantly reduced HbA1c Post OADs and Post Basal Insulin6,7



Complimentary FPG & PPG control3,4,5

SOLIQUA™ targets both FPG & PPG with a complementary mechanism of action3



Superior PPG control4

Excursion was calculated as 2-hour PPG value minus preprandial value. All values are mg/dl CI, confidence interval; GLP-1 RA, glucagon-like peptide-1 receptor agonist; PPG, postprandial plasma glucose  

Adapted from ref. 4

148 adults with T2DM insufficiently controlled (A1C 6.5−9.0%) on ≥1.5 g/day of metformin

Adapted from ref. 5



Well tolerated1,2

SOLIQUA™ provides the ability to gradually titrate a GLP-1 RA to allow low-risk of GI adverse reactions¹

Gastrointestinal (GI) adverse reactions in the Lixilan-O study



Favorable hypoglycemia profile1

No increased risk of hypoglycemia despite significant HbA1c reduction²

Superiority of SOLIQUA vs. basal insulin in patients with HbA1c >9%

Lower hypo events
with SOLIQUA


No weight gain¹

More patients achieve HbA1c target without weight gain²

 


Single daily injection³

SOLIQUA™ targets both FPG & PPG in a once daily injection¹⁻³

POST OAD

POST BASAL INSULIN

GLP-1 = glucagon-like peptide-1 (Lixisenatide), RA = receptor agonist, Basal insulin = Insulin glargine 100 units/ml, FPG = Fasting Plasma Glucose, PPG = Postprandial Glucose

    1. Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care 2016; 39: 2026–2035.
    2. Aroda VR, Rosenstock J, Wysham C, Unger J, Bellido D, González-Gálvez G, Takami A, Guo H, Niemoeller E, Souhami E, Bergenstal RM. Efficacy and safety of LixiLan, a titratable fixed-ratio combination of insulin glargine plus lixisenatide in type 2 diabetes inadequately controlled on basal insulin and metformin: the LixiLan-L randomized trial. Diabetes care. 2016; 39(11):1972-80.
    3. SOLIQUA™ SmPC as of July 2020.
    4. Blonde L, Rosenstock J, Del Prato S, et al. Switching to iGlarLixi Versus Continuing Daily or Weekly GLP-1 RA in Type 2 Diabetes Inadequately Controlled by GLP-1 RA and Oral Antihyperglycemic Therapy: The LixiLan-G Randomized Clinical Trial. Diabetes Care. 2019; 1-9.
    5. Kapitza C, Forst T, Coester HV, et al. Pharmacodynamic characteristics of lixisenatide once daily versus liraglutide once daily in patients with type 2 diabetes insufficiently controlled on metformin. Diabetes, Obesity and Metabolism. 2013; 15: 642–649.
    6. Niemoeller E, Souhami E, Wu Y, and Jensen KH. iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes Ther 2018; 9: 373–382.
    7. Davies MJ, Russell-Jones D, Barber TM, et al. Glycaemic benefit of iGlarLixi in insulin-naive type 2 diabetes patients with high HbA1c or those with inadequate glycaemic control on two oral antihyperglycaemic drugs in the LixiLan-O randomized trial. Diabetes Obes Metab. 2019; 21:1967–1972.

Starting Soliqua



Simple dosing with only once daily injection

Easy to use: Widely used SoloStar® pre-filled pen1,2

    1. SOLIQUA™ SmPC as of July 2020.
    2. Market share (02/2019) is 46.7 % (counting units) for the SoloSTAR® pen in ATC code A10C, NFC code RF pre-filled pens according to IQVIA MIDAS market share data 02/2019.

Start or titrate SOLIQUA™ dose according to your patients’ needs

    1. Rosenstock J, Aronson R, Grunberger G, et al. Benefits of LixiLan, a Titratable Fixed-Ratio Combination of Insulin Glargine Plus Lixisenatide, Versus Insulin Glargine and Lixisenatide Monocomponents in Type 2 Diabetes Inadequately Controlled on Oral Agents: The LixiLan-O Randomized Trial. Diabetes Care 2016; 39: 2026–2035.
    2. SOLIQUA™ SmPC as of July 2020.

MAT-BH-2100440/v2/Nov2021