- |||||||||| BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk, DegludecPlus (insulin degludec/insulin aspart) / Novo Nordisk
Journal: Glycaemic outcomes in hospital with IDegAsp versus BIAsp30 premixed insulins. (Pubmed Central) - Aug 18, 2024 Inpatients treated with IDegAsp compared to BIAsp30 had similar hypoglycaemia incidence, but higher hyperglycaemia incidence, potentially related to less frequent twice-daily dosing. With the increasing use of IDegAsp in the community, development of hospital management guidelines for this insulin formulation is needed.
- |||||||||| BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk, DegludecPlus (insulin degludec/insulin aspart) / Novo Nordisk
Retrospective data, Review, Journal: Efficacy and Safety of Insulin Degludec/Insulin Aspart versus Biphasic Insulin Aspart 30 in Patients with Type 2 Diabetes: A Meta-Analysis of Randomized Controlled Trials. (Pubmed Central) - Jun 19, 2024 However, there was no significant difference in the improvement of body weight change (P=0.99), glycosylated hemoglobin (P=0.50), the overall risk of hypoglycemic events (P=0.57) and adverse events (P=0.89) between the two groups. Compared with BIAsp30, IDegAsp could significantly reduce FPG levels, insulin dosage, and the risk of nocturnal hypoglycemic events in T2D patients, without increasing the overall risk of adverse events.
- |||||||||| BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Clinical, Journal: Bioequivalence of Reference and Biosimilar Preparations of Premixed Biphasic Insulin Aspart: A Comparative Clamp Study. (Pubmed Central) - Dec 4, 2023 Biphasic insulin aspart 30 is a premixed formulation containing a soluble fraction of insulin aspart (30%) and a protamine-crystallized fraction (70%) that was developed to combine the rapid-acting and prolonged advantages of commercially available insulins...The 90% confidence intervals for the geometric mean ratios of PK (C and AUC ) parameters of Gp-bi-asp and Novo-bi-asp were close to 100% and within the 80%-125% limits for establishing bioequivalence. The safety profiles of both drugs were also comparable.
- |||||||||| NovoLog Mix 70/30 (insulin aspart protamine 70%/insulin aspart 30%) / Novo Nordisk, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Observational data, Journal, Real-world evidence, Real-world: Glycaemia in low-premixed insulin analogue type 2 diabetes patients in a real-world setting: are the CGM targets met? (Pubmed Central) - Mar 12, 2023 The study indicates that the general type 2 diabetes population targets would mostly be met for TBR and %CV in our patients but not the TIR and TAR targets. CGM appears to be a useful clinical tool in these patients.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Journal: Findings for iGlarLixi vs BIAsp 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics. (Pubmed Central) - Nov 1, 2022 P3 Compared with BIAsp 30, IDegAsp was a cost-effective treatment option for people with T2DM with inadequate glycemic management on basal insulin in China. Treatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes, and renal function, supporting the use of iGlarLixi as an efficacious and well-tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Journal, Patient reported outcomes: Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial. (Pubmed Central) - Nov 1, 2022 P3 Treatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes, and renal function, supporting the use of iGlarLixi as an efficacious and well-tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics. In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Journal: Hypoglycaemia events with iGlarLixi versus premix biphasic insulin aspart 30 (BIAsp 30) in people with type 2 diabetes advancing from basal insulin: An analysis of the SoliMix trial. (Pubmed Central) - Nov 1, 2022 In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs. These results show that the lower HbA1c levels and weight benefit seen with iGlarLixi versus premixed BIAsp 30 in people with type 2 diabetes advancing their basal insulin therapy in the SoliMix trial are also accompanied by a lower risk of hypoglycaemia at any time of day and across a broad range of HbA1c levels.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Cost Per Responder and Number Needed to Treat of iGlarlixi vs Premix BIAsp 30 in Algerian Setting (In-person; Virtual) - Sep 1, 2022 - Abstract #ISPOREU2022ISPOR_EU_648; While iGlarLixi was associated with increased treatment costs, the cost per responder was lower than premix BIAsp 30 when considering all treatment effect. This analysis suggests iGlarLixi is an efficient alternative in Algeria
- |||||||||| BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Journal: PKPD Modeling and Simulations to Support Biosimilar Development of Biphasic Insulin Aspart 30. (Pubmed Central) - Aug 22, 2022 As a result, using real data along with model-based simulation data, a biosimilarity test for PD was performed, and the lower limit for became 82.6%, while the CV decreased from 31.7% to 24.1%. Thus, popPKPD modeling and simulations have been shown to be effective in interpreting and supporting the results of clinical biosimilarity trials.
- |||||||||| BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
PK/PD data, Journal: Modeling of Pharmacokinetic Profiles of Insulin Aspart and Biphasic Insulin Aspart 30 / 70. (Pubmed Central) - Aug 3, 2022 The developed PK model was fitted successfully to the experimental dataand all fitted parameters displayed a moderate coefficient of variation. The PK model allows us to predict PK profiles for various doses and formulations of insulin aspart and can be used to improve the accuracy, safety and ethics of novel clinical trials of insulin.
- |||||||||| BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Retrospective data, Journal, Monotherapy: Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis. (Pubmed Central) - Dec 16, 2021 Meanwhile, for patients with BMI ≤ 26 kg/m, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
[VIRTUAL] Connections and combinations: Supporting people to help control their diabetes Session 2 (Paris Hall) - Aug 26, 2021 - Abstract #EASD2021EASD_1528; In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy. Sponsored By SANOFI Combining efficacy and simplicity to help improve glycemic control The SoliMix trial was the first randomized controlled trial to directly compare the efficacy and safety of a fixed-ratio combination of basal insulin and GLP-1 RA, iGlarLixi, with a premix insulin analog, biphasic insulin aspart 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30), in people with Type 2 diabetes uncontrolled on basal insulin plus one or two oral antihyperglycemic drugs.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
[VIRTUAL] Advancing therapy in basal insulin users with type 2 diabetes: better clinical outcomes with iGlarLixi vs premix BIAsp 30 in the SoliMix trial (Saint Petersburg Hall) - Jul 13, 2021 - Abstract #EASD2021EASD_1321; P3 SoliMix, an open-label, multicentre study, was the first to compare these two insulin coformulations.Materials and SoliMix randomised adults with T2D and HbA1c 58-86 mmol/mol (7.5-10.0 %) on basal insulin + oral antihyperglycaemic drugs (OADs; metformin ± sodium-glucose co-transporter-2 inhibitors) to once-daily iGlarLixi or twice-daily premix biphasic insulin aspart 30 (BIAsp 30; 30% insulin aspart + 70% insulin aspart protamine). Based on better glucose control with weight benefit and less hypoglycaemia, once-daily iGlarLixi is a favourable alternative to twice-daily premix BIAsp 30 for advancing therapy in people with T2D uncontrolled on basal insulin + OADs.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
[VIRTUAL] Advancing injectable therapy in adults with T2D: Findings from the SoliMix trial (Paris Hall) - Jul 13, 2021 - Abstract #EASD2021EASD_1303; Based on better glucose control with weight benefit and less hypoglycaemia, once-daily iGlarLixi is a favourable alternative to twice-daily premix BIAsp 30 for advancing therapy in people with T2D uncontrolled on basal insulin + OADs. The SoliMix trial was the first randomized controlled trial to directly compare the efficacy and safety of a fixed-ratio combination of basal insulin and GLP-1 RA, iGlarLixi, with a premix insulin analog, biphasic insulin aspart 30 (30% insulin aspart and 70% insulin aspart protamine) (BIAsp 30), in people with Type 2 diabetes uncontrolled on basal insulin plus one or two oral antihyperglycemic drugs.; Sponsored By SANOFI
- |||||||||| NovoLog Mix 70/30 (insulin aspart protamine 70%/insulin aspart 30%) / Novo Nordisk, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Journal: Extreme insulin resistance during pregnancy: a therapeutic challenge. (Pubmed Central) - Jul 2, 2021 Obesity, PCOS, T2D and high levels of leptin and IGF-1 are predictors of severe insulin resistance in pregnancy. A close collaboration between patient, obstetricians and endocrinologists is crucial for tailoring the best possible treatment for pregnant women with diabetes, beneficial for both the mother and her child.
- |||||||||| Nesina (alogliptin) / Takeda, NovoLog Mix 70/30 (insulin aspart protamine 70%/insulin aspart 30%) / Novo Nordisk, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Clinical, Journal: Rare case of diabetic neuropathic cachexia along with diabetic amyotrophy. (Pubmed Central) - Jun 8, 2021 Patient was diagnosed with diabetic neuropathic cachexia secondary to poorly controlled diabetes and was commenced on 30 units two times per day of NovoMix 30 insulin; this was adjusted to 24 units two times per day in endocrine clinic 3 months later, after gaining 10 kg in weight. Good glycaemic control is key to the management of such cases and, therefore, we recommend early referral to diabetes specialist input for consideration of insulin therapy.
- |||||||||| Soliqua 100/33 (lixisenatide/insulin glargine) / Sanofi, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk, Lyxumia (lixisenatide) / Zealand Pharma, Sanofi
[VIRTUAL] Advancing Therapy in Basal Insulin Users with Type 2 Diabetes (T2D): Hypoglycemia as a Function of HbA1c in the SoliMix Trial () - May 29, 2021 - Abstract #ADA2021ADA_1700; SoliMix was a 26-week, open-label, multicenter study in which adults (N=887) with T2D and HbA 1c ≥7.5-≤10.0 % (≥58-≤86 mmol/mol) using basal insulin + metformin ± sodium-glucose co-transporter-2 inhibitors were randomized to once-daily iGlarLixi (fixed-ratio combination of basal insulin glargine 100 U/mL + lixisenatide) or twice-daily premix insulin 30/70 analog (BiAsp 30). Lower rates of hypoglycemia with iGlarLixi across a broad range of HbA 1c suggests that iGlarLixi facilitates greater HbA 1c improvement vs. premix insulin 30/70.
- |||||||||| metformin / Generic mfg., BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk, DegludecPlus (insulin degludec/insulin aspart) / Novo Nordisk
Clinical, P3 data, Journal: Efficacy and safety of insulin degludec/insulin aspart versus biphasic insulin aspart 30 in Chinese adults with type 2 diabetes: a phase 3, open-label, 2:1 randomized, treat-to-target trial. (Pubmed Central) - Jul 11, 2020 P3 Active, not recruiting --> Completed The efficacy and safety of IDegAsp in Chinese patients with type 2 diabetes was demonstrated, confirming results from international trials.
- |||||||||| NovoLog Mix 70/30 (insulin aspart protamine 70%/insulin aspart 30%) / Novo Nordisk, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Enrollment change, Trial withdrawal, Real-world evidence, Real-world: A Research Study, Looking at How NovoMix (clinicaltrials.gov) - Jun 4, 2020 P=N/A, N=0, Withdrawn, The efficacy and safety of IDegAsp in Chinese patients with type 2 diabetes was demonstrated, confirming results from international trials. N=918 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| GP-40081 (insulin aspart biphasic biosimilar) / Geropharm
Enrollment closed: Efficacy and Safety of GP40081 ?ompared to NovoMix (clinicaltrials.gov) - Apr 14, 2020 P3, N=264, Active, not recruiting, Compared with BIAsp30, BIAsp50 showed greater efficacy in patients with baseline BG excursion >7.8 mmol/L or 2hPBG >17.6 mmol/L as well as good safety for hypoglycaemia. Recruiting --> Active, not recruiting
- |||||||||| NovoLog Mix 70/30 (insulin aspart protamine 70%/insulin aspart 30%) / Novo Nordisk, BIAsp 30 (biphasic insulin aspart 30/70 biosimilar) / Novo Nordisk
Trial completion date, Trial primary completion date, Real-world evidence, Real-world: A Research Study, Looking at How NovoMix (clinicaltrials.gov) - Mar 2, 2020 P=N/A, N=918, Not yet recruiting, Recruiting --> Active, not recruiting Trial completion date: Dec 2020 --> May 2021 | Trial primary completion date: Dec 2020 --> May 2021
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