Apidra

Manufactured by Sanofi

Sourced in France, United States

Apidra is a rapid-acting insulin analog used in the treatment of diabetes. It is designed to help regulate blood sugar levels by providing insulin to the body. Apidra is administered through subcutaneous injection and is intended for use in both type 1 and type 2 diabetes management.

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Lab products found in correlation

Lantus, by Sanofi (4 mentions) Humalog, by Eli Lilly (3 mentions) Novorapid, by Novo Nordisk (2 mentions) Novolog, by Novo Nordisk (2 mentions) Streptozotocin (stz), by Merck Group (2 mentions) Phenol, by Novo Nordisk (1 mentions) Sb202190, by Bio-Techne (1 mentions) Su3327, by Bio-Techne (1 mentions) Insuman infusat, by Sanofi (1 mentions) Recombinant human insulin, by Roche (1 mentions) M cresol, by Merck Group (1 mentions) Sitagliptin, by MSD (1 mentions) Galvus, by Novartis (1 mentions) Humalog u100, by Eli Lilly (1 mentions)

9 protocols using apidra

Insulin Formulations and Kinase Inhibitors

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phenol (CAS No.108-95-2) and m-cresol (CAS No. 108-39-4) were obtained from Sigma–Aldrich. Jun N-terminal kinase (JNK) inhibitor SU3327 (10–20 μM in dimethyl sulfoxide (DMSO)) and p38 Inhibitor SB202190 (1–2 μM in DMSO) were from Tocris Bioscience.
The following formulations of insulin or insulin analogs were used, each at 100 I.U./ml: Apidra (3.15 mg/ml m-cresol, Sanofi-Aventis), Insuman Infusat (2.7 mg/ml phenol, Sanofi-Aventis), Humalog (3.15 mg/ml m-cresol, Eli Lilly), NovoRapid (1.72 mg/ml m-cresol and 1.5 mg/ml phenol, Novo Nordisk). Recombinant human insulin (Roche Diagnostics GmbH) was dissolved in phosphate buffer at 3 mg/ml (equivalent to 100 U/ml).

Weber C., Kammerer D., Streit B, & Licht A.H. (2014). Phenolic excipients of insulin formulations induce cell death, pro-inflammatory signaling and MCP-1 release. Toxicology Reports, 2, 194-202.

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Insulin Purification via Desalting Columns

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Apidra (Sanofi, Bridgewater, NJ ), Humalog (Eli Lilly & Co., Indianapolis, IN), and Novolog (Novo Nordisk, Plainsboro Township, NJ) purchased from a pharmacy were passed through spin Zeba desalting columns (Thermo Fisher Scientific, Waltham, MA) to remove phenolic compounds [22 (link)]. The column was placed in a 1.5–2.0mL collection tube and centrifuged at 1500 × g for 1 minute to remove storage solution. Next, 300μL of PBS was passed through the column by centrifugation at 1500 × g for 1 minute. After washing the resin 3 times, the column was placed in a new collection tube and commercial insulin was applied to the top of the compact resin bed. Insulin was eluted by centrifugation at 1500 × g for 2 minutes and collected. A standard protein assay (Thermo Fisher Scientific, Waltham, MA) was performed on the post-column eluates to confirm retrieval of insulin protein following removal of phenolic compounds.

Kesserwan S., Mulka A., Sharafieh R., Qiao Y., Wu R., Kreutzer D, & Klueh U. (2020). Advancing Continuous Subcutaneous Insulin Infusion in vivo: New Insights into Tissue Challenges. Journal of biomedical materials research. Part A, 109(7), 1065-1079.

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Cytotoxicity Evaluation of Insulin Analogs

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MTT assay is widely used to show loss of cellular metabolic activity (ATCC bioproducts, Manassas, VA). Cells undergoing analysis via the cytotoxicity assay were plated in a 48-well plate with 2.5x10⁵ cells/well. These cells were incubated overnight in 250µl of the growth media required for each individual cell line. Mouse cell lines and PBMCs were exposed to saline, sterile diluent (Eli Lilly and Company, Indianapolis, IN) and Humalog (Eli Lilly and Company, Indianapolis, IN) at a serial dilution of 1:3 for 1 and 3-days. PMBCs were also exposed to Apidra (Sanofi, Bridgewater, NJ ), Humalog (Eli Lilly & Co., Indianapolis, IN), and Novolog (Novo Nordisk, Plainsboro Township, NJ) with and without phenolic compounds at a serial diluent of 1:3 for 1-day. Following an incubation period of 3 days for PBMC and 1- and 3-days for mouse cell lines, 30µl of MTT reagent was added to each well and plates were incubated for 1 hour at 37°C until visibility of purple precipitate. Next, all supernatants were discarded and 300µl DMSO was added, mixed well, and 100µl samples were transferred to a 96-well plate in duplicates. Absorbance was read at 570 nm for analysis.

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Insulin Therapy for Glycemic Control

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During the run‐in period, participants were hospitalized, and stopped previous OADs except for MET (no changed dosage), then received short‐term intensive insulin therapy with Gla (Lantus; Sanofi) and bolus insulin glulisine (Apidra; Sanofi). All participants who had an FPG of less than 7.0 mmol/L and 2‐hour postprandial glucose (PPG) of less than 10.0 mmol/L in the last 2 consecutive days of the run‐in period were discharged from hospital and randomly assigned (1:1) to receive once‐daily basal insulin glargine in combination with a dipeptidyl peptidase‐4 inhibitor (DPP4i; either sitagliptin [Januvia; MSD, Beijing, China] or vildagliptin [Galvus; Novartis, Beijing, China]) or twice‐daily premixed insulin aspart (Asp30; Novolog Mix 70/30; Novo Nordisk, Tianjin, China). All participants continued to receive their background MET. Randomization was performed using centralized interactive response technology and was stratified by baseline sulphonylurea/glinide use and HbA1c level at screening (>9.0% or ≤9.0% [>75 or ≤75 mmol/mol]). While participants, investigators and site staff remained unmasked to treatment, the statistician and sponsor were masked to the treatment assignment until after database lock and completion of analyses.

Pan Q., Li Y., Wan H., Wang J., Xu B., Wang G., Jiang C., Liang L., Feng W., Liu J., Wang T., Zhang X., Cui N., Mu Y, & Guo L. (2022). Efficacy and safety of a basal insulin + 2‐3 oral antihyperglycaemic drugs regimen versus a twice‐daily premixed insulin + metformin regimen after short‐term intensive insulin therapy in individuals with type 2 diabetes: The multicentre, open‐label, randomized controlled BEYOND‐V trial. Diabetes, Obesity & Metabolism, 24(10), 1957-1966.

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Pancreatectomy and Diabetes Induction in Monkeys

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Pancreatectomy and the induction, confirmation, and maintenance of insulin-dependent diabetes mellitus in cynomolgus monkeys were performed as previously described^{33 (link)}. Briefly, the donor monkey’s pancreas was removed through subtotal (> 70% of the pancreas) or total pancreatectomy. The removed pancreas was used for islet isolation, and the donor monkey whose pancreas was removed became a recipient monkey after an injection of 60–80 mg/kg of streptozotocin (SIGMA, St Louis, MO, USA). Diabetes mellitus was diagnosed when the following criteria were satisfied: (1) sustained hyperglycemia (blood glucose level > 250 mg/dl), (2) fasting C-peptide level < 0.5 ng/ml, and (3) decrease in stimulated C-peptide response in the IVGTT. After the onset of diabetes and islet transplantation, the blood glucose level was monitored 2–4 times daily, and exogenous insulin (glargine: Lantus; SANOFI-AVENTIS, Bridgewater, NJ, USA, and glulisine: Apidra, SANOFI-AVENTIS) were used to maintain blood glucose levels < 200 mg/kg to protect the animals from hyperglycemia (Fig. 2).

Kim G.S., Cho C.W., Lee J.H., Shin D.Y., Lee H.S., Lee K.W., Kwon Y., Kim J.S., Yang H.M., Kim S.J, & Park J.B. (2021). Optimal allogeneic islet dose for transplantation in insulin-dependent diabetic Macaca fascicularis monkeys. Scientific Reports, 11, 8617.

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Insulin Treatment in Diabetic Rats

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Thirty-six rats were randomly assigned to four groups: rats with normal glucose levels that received sodium citrate buffer vehicle (normal glucose group [NOR], n=10); diabetic rats that did not receive treatment (diabetes mellitus [DM], n=8); diabetic rats who were administered subcutaneous injections of 15 to 20 IU/kg insulin glargine (Lantus^®, Sanofi-Aventis, Paris, France), once daily at 4:00 PM (DM+LAN, n=9); and diabetic rats who were administered insulin glargine, as described before, and approximately 5 to 10 IU/kg insulin glulisine (Apidra^®, Sanofi-Aventis) twice daily every 12 hours, at 8:00 AM and 8:00 PM (DM+LAN+API, n=9). The NOR and DM groups received an equal volume of saline solution at 8:00 AM, 4:00 PM, and 8:00 PM. The DM+LAN group also received saline injections at 8:00 AM and 8:00 PM.
Administration of insulin started 1 month after STZ injections, and this time point was defined as week 0. Body weight was measured every 2 weeks. Evaluation of behavior, plasma anti-oxidant enzymes, and morphometric parameters of cutaneous and sciatic nerves was performed at week 24.

Kim Y.J., Lee N.Y., Lee K.A., Park T.S, & Jin H.Y. (2021). Influence of Glucose Fluctuation on Peripheral Nerve Damage in Streptozotocin-Induced Diabetic Rats. Diabetes & Metabolism Journal, 46(1), 117-128.

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Single-Dose Comparison of URLi and Humalog

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Patients were randomised to receive a single 15-unit subcutaneous dose of study drug (URLi or Humalog U100 formulations [Eli Lilly, Indianapolis, IN, USA]) in the first dosing period and the alternate study drug in the second dosing period (Fig. 1). Before each dosing period, patients discontinued their basal insulin for a predefined washout period (≥72 h for insulin degludec or insulin glargine U300, ≥ 48 h for insulin detemir or glargine, ≥ 24 h for neutral protamine Hagedorn or other intermediate-acting insulins, and ≥ 6 h for any bolus injection of short-acting insulin via CSII). Patients receiving CSII therapy were to switch to insulin glulisine (Apidra^®; Sanofi, Paris, France) ≥ 8 h before dosing and to discontinue basal insulin delivery ≥ 3 h before dosing. An outpatient period of 3–15 days occurred between dosing periods. Follow-up was conducted ≥ 14 days after the second dosing period.Fig. 1

Trial design. SC subcutaneous, U units, URLi ultra rapid lispro

Linnebjerg H., Zhang Q., LaBell E., Dellva M.A., Coutant D.E., Hövelmann U., Plum-Mörschel L., Herbrand T, & Leohr J. (2020). Pharmacokinetics and Glucodynamics of Ultra Rapid Lispro (URLi) versus Humalog® (Lispro) in Younger Adults and Elderly Patients with Type 1 Diabetes Mellitus: A Randomised Controlled Trial. Clinical Pharmacokinetics, 59(12), 1589-1599.

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Induction and Maintenance of Type 1 Diabetes in Cynomolgus Monkeys

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All procedures for the induction, confirmation, and maintenance of type 1 diabetes in cynomolgus monkeys were performed as previously described^{53 (link)}. Briefly, diabetes was induced by injecting 60 mg/kg streptozotocin (Sigma, St. Louis, MO, USA) after surgical removal of >70% of the recipient monkey’s pancreas. Confirmation of diabetes was based on the following three criteria: (1) blood glucose level (>250 mg/dL), (2) fasting C-peptide level < 0.5 ng/mL, and (3) the absence of stimulated C-peptide and endogenous insulin response based on the intravenous glucose tolerance test (IVGTT). After successful induction of diabetes and islet transplantation, blood glucose levels were checked 3 to 4 times daily, and exogenous insulin (glargine: Lantus; Sanofi-Aventis, Bridgewater, NJ, USA, and glulisine: Apidra, Sanofi-Aventis) was used to maintain blood glucose levels < 200 mg/kg.

Kim G.S., Lee J.H., Shin D.Y., Lee H.S., Park H., Lee K.W., Yang H.M., Kim S.J, & Park J.B. (2020). Integrated whole liver histologic analysis of the allogeneic islet distribution and characteristics in a nonhuman primate model. Scientific Reports, 10, 793.

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Glycemic Response to Insulin Analogues in T2DM

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A randomized, single-center, open-label, crossover study was conducted in 12 hospitalized male patients with T2DM (the Japan Diabetes Society criteria of 2010 [9] ). Randomization was conducted according to the order of study attendance. Sixteen patients were recruited to the study, but 4 patients could not complete the study due to the violation of the study protocol. Finally, 12 patients (7 patients started with Glu and 5 patients started with Asp) completed the study. Glu or Asp was subcutaneously administered just before standard Japanese-style breakfast (530 kcal: 55% carbohydrate, 20% protein and 25% fat) in the morning. In patients with IIT, insulin dosage of each patient was determined as the ordinary dose of pre-prandial rapidacting insulin. On the other hand, dosage of insulin was determined as 0.1 unit/kg for patients treated with oral anti-hyperglycemic drugs (OADs). Vials of Glu (Apidra, Sanofi, Paris, France) and Asp (Novorapid, Novo-Nordisk, Copenhagen, Denmark) were pur- sodes was symptomatic nor considered as severe as to require assistance from another person. In patients with BMI < 25 kg/m 2 (n = 6), post-exercise plasma glucose levels were significantly lower in Asp group at 90, 120 and 150 min than in Glu group (p < 0.05). However, in subjects with BMI ≥ 25 kg/m 2 (n = 6) the difference was minimal (Fig. 3).

Tanaka N, & Hiura Y. (2015). Effects of rapid-acting insulin analogues insulin glulisine and insulin aspart on postprandial glycemic excursion with single bout of exercise in patients with type 2 diabetes. Endocrine journal, 62(5).

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