PARIS, June 28, 2021 /PRNewswire/ -- A new study of Soliqua® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL, iGlarLixi, met its two primary endpoints and all key secondary endpoints in a head-to-head comparison against premixed insulin (biphasic insulin aspart 30, BIAsp 30) in adults living with type 2 diabetes, the most common form of diabetes, uncontrolled on insulin and one or two oral anti-diabetic medicines. The findings were presented today at the American Diabetes Association (ADA) 81st Scientific Sessions1 and simultaneously published in Diabetes Care.2
The study met both primary endpoints with Soliqua 100/33 demonstrating noninferiority of blood sugar (HbA1c) reduction and superiority on body weight change from baseline compared to premixed insulin. The study also met its key secondary endpoints with Soliqua 100/33 achieving a greater proportion of people reaching a HbA1c target of <7% without weight gain, a greater proportion of people reaching a HbA1c target of <7% without weight gain and without hypoglycemia, and superiority in reduction of HbA1c compared with those using premixed insulin.
"Concerns about hypoglycemia and weight gain are known barriers when advancing basal insulin therapy, especially with complex insulin regimens," says Julio Rosenstock, Director of the Dallas Diabetes Research Center at Medical City, Dallas, TX, and main author of the study. "These results show improved outcomes with iGlarLixi over BIAsp 30, demonstrating better glucose control without body weight gain and less hypoglycemia. This combined benefit could help clinicians consider advancing basal insulin therapy by switching to a once-daily fixed-ratio combination of basal insulin plus a GLP-1 receptor agonist rather than switching to a twice-daily premixed insulin regimen."
A secondary analysis also found study participants using Soliqua 100/33 reported greater improvements in patient-reported outcomes compared to premixed insulin as measured by Treatment-Related Impact Measure Diabetes (TRIM-D) and patient- and physician-rated Global Treatment Effectiveness Evaluation (GTEE) scores.3 These tools include measurements of treatment burden, daily life, diabetes management, compliance, psychological health, and treatment effectiveness.
"Despite the advances in diabetes care, many people living with type 2 diabetes are unable to reach their HbA1c goals," said Luigi Meneghini, M.D., US Medical Head of Diabetes, General Medicines at Sanofi. "This study highlights appropriate options for earlier treatment intensification for those not reaching their blood sugar goals, and these data suggest that Soliqua 100/33 may be a superior therapy for these people compared to premixed insulins."
Safety findings were in line with the established profiles of Soliqua 100/33 and premixed insulin.
About the SoliMix study
The SoliMix study was a 26-week, randomized controlled trial of 887 adults living with type 2 diabetes who were uncontrolled on insulin plus metformin with or without a sodium-glucose cotransporter-2 inhibitor (SGLT-2i). The study compared the efficacy and safety of Soliqua 100/33 compared to a commonly used premixed insulin (BIAsp 30). Participants were randomized to switch from their prior insulin to either Soliqua 100/33 once daily or premixed insulin twice daily, with starting doses determined and adjusted weekly. Any metformin or SGLT-2i treatment was maintained through the study period.
The study met its two primary endpoints and all three of its key secondary endpoints.
SoliMix Data Summary |
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Soliqua 100/33 (n=443) |
Premixed Insulin (n=444) |
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HbA1c, % |
Baseline |
8.61 ± 0.67 |
8.57 ± 0.65 |
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LS mean change from baseline to Week 26 ± SE |
-1.30 ± 0.06 |
-1.05 ± 0.06 |
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LS mean difference (97.5% CI)*
p-value for non-inferiority†
LS mean difference (95% CI)‡
p-value for superiority§ |
-0.24 (-0.41, -0.08)
p<0.001
-0.24 (-0.39, -0.10)
p<0.001 |
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HbA1c, mmol/mol |
Baseline |
70.6 ± 7.3 |
70.2 ± 7.1 |
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LS mean change from baseline to Week 26 ± SE |
-14.2 ± 0.7 |
-11.5 ± 0.7 |
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LS mean difference (97.5% CI)*
p-value for non-inferiority†
LS mean difference (95% CI)‡
p-value for superiority§ |
-2.6 (-4.5, -0.9)
p<0.001
-2.6 (-4.3, -1.1)
p<0.001 |
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Bodyweight, kg |
Baseline |
80.7 ± 16.5 |
82.2 ± 18.5 |
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LS mean change from baseline to Week 26 ± SE |
-0.70 ± 0.20 |
+1.15 ± 0.20 |
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LS mean difference (95% CI)
p-value for superiority* |
-1.86 (-2.28, -1.43)
p<0.001 |
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HbA1c <7 % without weight gain, n (%)
Odds ratio (95% CI)‡ |
122 (27.5) |
55 (12.4) |
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HbA1c <7 % without weight gain and without hypoglycemia (plasma glucose <70 mg/dL [<3.9 mmol/L]), n (%)
Odds ratio (95% CI)‡ |
86 (19.4) |
31 (7.0) |
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3.40 (2.19, 5.28); p<0.001 |
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HbA1c <7 %, n (%)§
Odds ratio (95% CI) |
187 (42.2) |
141 (31.8) |
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1.65 (1.25, 2.19) |
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Incidence and rates of hypoglycemia (safety population) |
n=442 223.15 PY |
n=441 217.85 PY |
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Level 1 (ADA definition: <70 mg/dL [<3.9 mmol/L] and ≥54 mg/dL [≥3.0 mmol/L]) |
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n (%)
Odds ratio (95% CI)
PPY (events)
Rate ratio (95% CI) |
114 (25.8) |
170 (38.5) |
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0.55 (0.42, 0.74)
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2.03 (453) |
2.83 (616) |
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0.71 (0.52, 0.99) |
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Level 2 (ADA definition: <54 mg/dL [<3.0 mmol/L]) |
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n (%)
Odds ratio (95% CI)
PPY (events)
Rate ratio (95% CI) |
28 (6.3) |
57 (12.9) |
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0.45 (0.28, 0.73)
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0.25 (56) |
0.56 (121) |
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0.40 (0.23, 0.71) |
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Level 3 (ADA definition: severe hypoglycemia)¶ |
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n (%)
Odds ratio (95% CI)
PPY (events)
Rate ratio (95% CI) |
1 (0.2) |
2 (0.5) |
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0.50 (0.04, 5.56)
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0 (1) |
0.01 (2) |
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0.49 (0.04, 5.40) |
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Data shown are mean ± SD unless otherwise specified. *Primary endpoint was assessed at 0.025 for non-inferiority on HbA1c change from baseline then 0.05 for other endpoints, as the alpha was distributed to subsequent tests. †Two primary efficacy endpoints, non-inferiority of HbA1c reduction assessed using a margin of 0.3 %; ‡Secondary endpoint was assessed at the alpha 0.05 level. §Secondary endpoint. ¶A hypoglycemic event with severe cognitive impairment (hypoglycemic unconsciousness) requiring external assistance for recovery.
ADA, American Diabetes Association; AE, adverse event; BiAsp, biphasic aspart insulin; BMI, body mass index; CI, confidence interval; iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/mL and the glucagon-like peptide-1 receptor agonist, lixisenatide; ITT, intent to treat population; LS, least squares; PPY, per participant-year; PY, participant-year; SD, standard deviation; SE, standard error; T2D, type 2 diabetes. |
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In a secondary analysis, participants using Soliqua 100/33 also reported greater improvements in patient-reported outcomes as measured by TRIM-D and patient- and physician-rated GTEE scores at 26 weeks.
Safety findings were in line with the established profiles of both treatments. The most commonly reported adverse events in the study were hypoglycemia (31.2% Soliqua 100/33, 42.4% premixed insulin), nausea (7.7% Soliqua 100/33, 0% premixed insulin), headache (2.5% Soliqua 100/33, 0.5% premixed insulin), dizziness (1.4% Soliqua 100/33, 0.5% premixed insulin), and vomiting (1.1% Soliqua 100/33, 0.2% premixed insulin).
About Soliqua 100/33
Soliqua 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise.
Important Safety Information
What is the most important information I should know about Soliqua 100/33?
Do not share your Soliqua 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Soliqua 100/33 can cause serious side effects, including inflammation of the pancreas, which may be severe and lead to death.
Before using Soliqua 100/33, tell your doctor if you have had pancreatitis, stones in your gallbladder (cholelithiasis), or a history of alcoholism. These medical problems may make you more likely to get pancreatitis.
Stop taking Soliqua 100/33 and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe, and will not go away. The pain may be felt in the back area. The pain may happen with or without vomiting.
Who should not use Soliqua 100/33?
Do not use Soliqua 100/33 if you:
Before using Soliqua 100/33, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including all prescription and over-the-counter medicines, vitamins, and herbal supplements. Soliqua 100/33 may affect the way some medicines work. Before using Soliqua 100/33, talk to your healthcare provider about low blood sugar and how to manage it.
How should I use Soliqua 100/33?
What are the possible side effects of Soliqua 100/33?
Soliqua 100/33 may cause serious side effects, including:
The most common side effects of Soliqua 100/33 include low blood sugar (hypoglycemia), nausea, diarrhea, upper respiratory infection, stuffy or runny nose, and headache. Nausea and diarrhea usually happen more often when you first start using Soliqua 100/33.
Click here for full Prescribing Information for Soliqua 100/33.
References
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