New Soliqua®* data shows improved blood sugar control without weight gain versus premixed insulin
- Study also shows more people on Soliqua had improved blood sugar control without weight gain and without low blood sugar events (hypoglycemia) in first head-to-head comparison with premixed insulin
LAVAL, QC, June 28, 2021 /CNW Telbec/ - A new study of Soliqua (insulin glargine 100 Units/mL and lixisenatide, 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 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 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 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.
"While premixed is used by around 40% of people taking insulin globally to manage their type 2 diabetes today, recent real-world evidence suggests only 18.2% of people using it reach their blood sugar goal,"4,5 said Sandra Silvestri, M.D., Ph.D., Global Medical Head of General Medicines at Sanofi. "Today's results provide further information on Soliqua's impact and patient-reported outcomes that could be considered by healthcare providers."
Safety findings were in line with the established profiles of Soliqua 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 compared to a commonly used premixed insulin (BIAsp 30). Participants were randomized to switch from their prior insulin to either Soliqua 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 | ||||
Soliqua (n=443) | Premixed Insulin | |||
HbA1c, % | Baseline | 8.61 ± 0.67 | 8.57 ± 0.65 | |
LS mean change from baseline | -1.30 ± 0.06 | -1.05 ± 0.06 | ||
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 | |||
HbA1c, mmol/mol | Baseline | 70.6 ± 7.3 | 70.2 ± 7.1 | |
LS mean change from baseline | -14.2 ± 0.7 | -11.5 ± 0.7 | ||
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 | |||
Bodyweight, kg | Baseline | 80.7 ± 16.5 | 82.2 ± 18.5 | |
LS mean change from baseline | -0.70 ± 0.20 | +1.15 ± 0.20 | ||
LS mean difference (95% CI) p-value for superiority* | -1.86 (-2.28, -1.43) p<0.001 | |||
HbA1c <7 % without weight gain, n (%) Odds ratio (95% CI)‡ | 122 (27.5) | 55 (12.4) | ||
2.83 (1.98, 4.04); p<0.001 | ||||
HbA1c <7 % without weight gain and without Odds ratio (95% CI)‡ | 86 (19.4) | 31 (7.0) | ||
3.40 (2.19, 5.28); p<0.001 | ||||
HbA1c <7 %, n (%)§ Odds ratio (95% CI) | 187 (42.2) | 141 (31.8) | ||
1.65 (1.25, 2.19) | ||||
Incidence and rates of hypoglycemia | n=442 223.15 PY | n=441 217.85 PY | ||
Level 1 (ADA definition: <70 mg/dL [<3.9 mmol/L] and ≥54 mg/dL [≥3.0 mmol/L]) | ||||
n (%) Odds ratio (95% CI) PPY (events) Rate ratio (95% CI) | 114 (25.8) | 170 (38.5) | ||
0.55 (0.42, 0.74) | ||||
2.03 (453) | 2.83 (616) | |||
0.71 (0.52, 0.99) | ||||
Level 2 (ADA definition: <54 mg/dL [<3.0 mmol/L]) | ||||
n (%) Odds ratio (95% CI) PPY (events) Rate ratio (95% CI) | 28 (6.3) | 57 (12.9) | ||
0.45 (0.28, 0.73) | ||||
0.25 (56) | 0.56 (121) | |||
0.40 (0.23, 0.71) | ||||
Level 3 (ADA definition: severe hypoglycemia)¶ | ||||
n (%) Odds ratio (95% CI) PPY (events) Rate ratio (95% CI) | 1 (0.2) | 2 (0.5) | ||
0.50 (0.04, 5.56) | ||||
0 (1) | 0.01 (2) | |||
0.49 (0.04, 5.40) | ||||
Data shown are mean ± SD unless otherwise specified. *Primary endpoint was assessed at 0.025 for ADA, American Diabetes Association; AE, adverse event; BiAsp, biphasic aspart insulin; BMI, body | ||||
In a secondary analysis, participants using Soliqua also reported greater improvements in patient-reported outcomes as measured by TRIM-D and patient- and physician-rated GTEE scores at 26 weeks.
- TRIM-D results demonstrated greater improvements for participants using Soliqua compared to those using premixed insulin, across domains including compliance, diabetes management, and psychological health, among others.3
- GTEE findings showed that nearly twice as many patients reported complete control of their diabetes with Soliqua compared to premixed insulin (27.5% vs 15%). Similarly, nearly twice as many physicians also reported treatment effectiveness (i.e., complete control of diabetes) with Soliqua compared to premixed insulin (29.9% vs 15.3%).3
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, 42.4% premixed insulin), nausea (7.7% Soliqua, 0% premixed insulin), headache (2.5% Soliqua, 0.5% premixed insulin), dizziness (1.4% Soliqua, 0.5% premixed insulin), and vomiting (1.1% Soliqua, 0.2% premixed insulin).
* |
SOLIQUA®, a fixed ratio combination of insulin glargine and lixisenatide, once daily injection, is indicated in combination with metformin as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus inadequately controlled on: [PM p. 4A] basal insulin (<60 units daily) alone or in combination with metformin, a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in combination with metformin |
References | |
1. | Rosenstock, J., et al. "Advancing Therapy in Uncontrolled Basal Insulin-Treated Type 2 Diabetes (T2D): Better Clinical Outcomes with iGlarLixi vs Premix 70/30 in the SoliMix Trial", Presentation 234-OR, American Diabetes Association (ADA) 81st Scientific Sessions (virtual event), June 28, 2021. |
2. | Rosenstock, J., et al. 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. Diabetes Care. 2021 Jun 28. |
3. | Polonsky, W., et al. "Improved Treatment Perceptions with iGlarLixi vs Premix Insulin in Type 2 Diabetes (T2D) Uncontrolled on Basal Insulin (BI) + Oral Antihyperglycemic Drugs (OADs): Patient-reported Outcomes (PROs) of the SoliMix Trial", Presentation 747-P, American Diabetes Association (ADA) 81st Scientific Sessions (virtual event), June 28, 2021. |
4. | Source: Market sales data, IQVIA |
5. | Jude E., et al. Effectiveness of premix insulin in type 2 diabetes: a retrospective UK cohort study. Diabetes Obes Metab. 2021;23:929-937. |
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