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Indian Journal of Endocrinology and... 2016Type 2 diabetes (T2D) represents an escalating burden worldwide, particularly in China and India. Compared with Caucasians, Asian people with diabetes have lower body... (Review)
Review
Type 2 diabetes (T2D) represents an escalating burden worldwide, particularly in China and India. Compared with Caucasians, Asian people with diabetes have lower body mass index, increased visceral adiposity, and postprandial glucose (PPG)/insulin resistance. Since postprandial hyperglycemia contributes significantly to total glycemic burden and is associated with heightened cardiovascular risk, targeting PPG early in T2D is paramount. Premixed insulin regimens are widely used in Asia due to their convenience and effectiveness. Data from randomized controlled trials and observational studies comparing efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) with biphasic insulin lispro mix (LM 25/50) and versus other insulin therapies or oral antidiabetic drugs (OADs) in T2D demonstrated that BIAsp 30 and LM 25/50 were associated with similar or greater improvements in glycemic control versus comparator regimens, such as basal-bolus insulin, in insulin-naÏve, and prior insulin users. Studies directly comparing BIAsp 30 and LM 25 provided conflicting glycemic control results. Safety data generally showed increased hypoglycemia and weight gain with premixed insulins versus basal-bolus insulin or OADs. However, large observational trials documented improvements in glycated hemoglobin, PPG, and hypoglycemia with BIAsp 30 in multi-ethnic patient populations. In summary, this literature review demonstrates that premixed insulin regimens are an appropriate and effective treatment choice in T2D.
PubMed: 27186543
DOI: 10.4103/2230-8210.179993 -
Diabetic Medicine : a Journal of the... Apr 2020Achieving optimal blood glucose control in Type 1 diabetes is a delicate balance between ensuring tight glycaemic control and achieving this without the expense of... (Review)
Review
Achieving optimal blood glucose control in Type 1 diabetes is a delicate balance between ensuring tight glycaemic control and achieving this without the expense of hypoglycaemia and weight gain, two major factors impacting quality of life. This is a real challenge for people with Type 1 diabetes and underpins many of the struggles they face in self-managing on a day-to-day basis. The main goals of insulin delivery are to try to simulate the physiology of β-cell insulin secretion as closely as possible and to overcome the challenges of peripheral insulin administration by achieving rapidity of onset with mealtime insulins and stability of the glucose-lowering effects of long-acting insulins. Since the early days of human insulin use, there have been many developments in insulin formulations that aim to achieve these goals as much as possible, thus contributing to better glycaemic control whilst minimizing hypoglycaemia. In the present review we discuss the currently available insulin analogues and the challenges of achieving glucose control using current analogues in those on multiple daily injections, and appraise the evidence base for newer-generation insulin analogues, such as insulin degludec, glargine U300, faster-acting insulin aspart and BioChaperone lispro. We also highlight new insulins in development and unmet needs in people with Type 1 diabetes.
Topics: Blood Glucose; Diabetes Mellitus, Type 1; Drug Administration Schedule; Drug Development; Drugs, Investigational; Glycated Hemoglobin; Glycemic Control; Health Services Needs and Demand; Humans; Injections; Insulin; Quality of Life; Therapies, Investigational
PubMed: 30585663
DOI: 10.1111/dme.13891 -
American Family Physician Jan 1998Research has established the importance of maintaining blood glucose levels near normal in patients with type 1 (insulin-dependent) diabetes mellitus. Short-acting... (Review)
Review
Research has established the importance of maintaining blood glucose levels near normal in patients with type 1 (insulin-dependent) diabetes mellitus. Short-acting insulin analogs are designed to overcome the limitations of regular short-acting insulins. Compared with regular human insulin, the analog insulin lispro offers faster subcutaneous absorption, an earlier and greater insulin peak and a more rapid postpeak decrease. Insulin lispro begins to exert its effects within 15 minutes of subcutaneous administration, and peak levels occur 30 to 90 minutes after administration. Duration of activity is less than five hours. Rates of insulin allergy, lipodystrophy, hypoglycemia and abnormal laboratory test results are essentially the same in patients using insulin lispro and in those using regular human insulin.
Topics: Blood Glucose; Diabetes Mellitus; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Insulin Lispro; Patient Education as Topic
PubMed: 9456992
DOI: No ID Found -
Journal of Diabetes Science and... May 2018SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps).
METHODS
This was a randomized, open-label, 2 × 4-week, two-arm crossover study in 27 patients with type 1 diabetes mellitus (NCT02603510). The main outcome was the incidence of infusion set occlusions (ISOs), defined as failure to correct hyperglycemia (plasma glucose ≥≥ 300 mg/dl) by 50 mg/dl within 60 minutes by insulin bolus via the pump. Secondary outcomes included intervals between infusion set changes, treatment-emergent adverse events (TEAEs) including infusion site, hypersensitivity reactions and hypoglycemic events, and safety.
RESULTS
The number of patients reporting at least one ISO was small: 6/25 patients on SAR-Lis reported 14 ISOs and 4/27 on Ly-Lis reported nine ISOs. The estimated difference in ISO risk for SAR-Lis versus Ly-Lis was 7.9% (95% CI, -1.90 to 17.73). Mean interval between infusion set changes for any reason was similar with SAR-Lis (3.09 days) and Ly-Lis (2.95 days). The event rate (events/patient-month) of any hypoglycemia was similar with SAR-Lis (7.15) and Ly-Lis (7.98), as was the percentage of patients who experienced any TEAE (12.0% and 14.8%).
CONCLUSION
Both SAR-Lis and Ly-Lis were well tolerated by patients using insulin pumps. The results do not suggest a clinically significant difference in the risk of ISO between SAR-Lis and Ly-Lis when used in CSII.
Topics: Adult; Aged; Biosimilar Pharmaceuticals; Cross-Over Studies; Diabetes Mellitus, Type 1; Equipment Failure; Female; Humans; Hypoglycemic Agents; Insulin Infusion Systems; Insulin Lispro; Male; Middle Aged
PubMed: 29359575
DOI: 10.1177/1932296817753644 -
Diabetology International Jul 2021The control of postprandial plasma glucose (PPG) excursions is critical in the prevention of diabetic complications. Controversy remains on the differences in...
OBJECTIVE
The control of postprandial plasma glucose (PPG) excursions is critical in the prevention of diabetic complications. Controversy remains on the differences in postprandial actions of insulin glulisine and lispro. The aim of this study was to define the differences in the efficacy of these two insulin analogues on PPG.
METHODS
The study subjects were 20 in-hospital patients with type 2 diabetes mellitus (T2DM). Plasma glucose (PG) was tightly controlled with basal insulin and insulin glulisine or lispro, and then glulisine or lispro were switched to the other insulin analog every other day for 6 study days. PG was measured before breakfast and 0.5-, 1-, and 2 h-postprandial during the study. Postprandial plasma C-peptide and lipids were analyzed in the first 2 days of the study. Postprandial increments in each parameter were compared between glulisine and lispro.
RESULTS
Whereas the median value of 0.5 h-Δ-PPG was comparable in glulisine and lispro, the 1 h-Δ-PPG was significantly lower with lispro than with glulisine (41 vs 53 mg/dl, respectively, = 0.03). Similarly, the 2 h-Δ-PPG with lispro was 10 mg/dl lower than that with glulisine (35 vs 45 mg/dl, respectively, = 0.05). In parallel with PPG, Δ-C-peptide at 1- and 2 h-postprandial were significantly lower with lispro than glulisine (0.50 vs 0.75 ng/ml, respectively, and 0.55 vs 0.75 ng/ml, respectively). The increment in LDL-C and HDL-C was significantly lower with lispro than with glulisine at 0.5 h-postprandial.
CONCLUSION
Insulin lispro seems superior to glulisine in the control of PPG in Japanese patients with T2DM.
PubMed: 34150441
DOI: 10.1007/s13340-020-00475-1 -
Journal of Veterinary Internal Medicine Jul 2019Intravenous continuous rate infusion (IVCRI) of lispro at a starting dose of 0.09 U/kg/h and the use of 0.9% sodium chloride (NaCl) for fluid resuscitation in cats...
BACKGROUND
Intravenous continuous rate infusion (IVCRI) of lispro at a starting dose of 0.09 U/kg/h and the use of 0.9% sodium chloride (NaCl) for fluid resuscitation in cats with diabetic ketoacidosis (DKA) have not been reported. Protocols for correction of electrolyte deficiencies in cats with DKA are lacking.
OBJECTIVES
To characterize the use of IVCRI lispro at an initial dose of 0.09 U/kg/h and the use of NaCl for resuscitation. Explore protocols for electrolyte supplementation in cats with DKA.
ANIMALS
Twelve cats with DKA enrolled from the cat population of a university hospital.
METHODS
Randomized, controlled, blinded study. Six cats were randomized into each group, the lispro insulin treatment group (LITG) and regular insulin treatment group (RITG). All cats received IVCRI fluid resuscitation with NaCl. Solutions with higher than previously published electrolyte concentrations were used to treat electrolyte deficiencies.
RESULTS
The median time to blood glucose (BG) concentration <250 mg/dL was significantly shorter in the LITG (median 7 hours, 2-10 hours) than the RITG (median 12.5 hours, 8-20 hours; P = .02). Two cats had nonclinical hypoglycemia (BG = 40 mg/dL). The most rapid change in 157 measurements of corrected sodium concentrations was 0.7 mmol/L/h. Low concentrations of serum sodium, potassium, phosphate, and magnesium were over 3 times more common than above normal electrolyte concentrations, despite supplementation with fluids of high electrolyte concentrations.
CONCLUSIONS AND CLINICAL IMPORTANCE
Lispro at a starting dose of 0.09 U/kg/h and NaCl administered for fluid resuscitation are safe and effective for treatment of DKA in cats.
Topics: Animals; Blood Glucose; Cat Diseases; Cats; Diabetic Ketoacidosis; Electrolytes; Female; Infusions, Intravenous; Insulin; Insulin Lispro; Male; Random Allocation; Saline Solution
PubMed: 31134702
DOI: 10.1111/jvim.15518 -
Clinical Pharmacology in Drug... Jun 2022This phase 1 study compared the pharmacokinetic (PK) and glucose pharmacodynamic (PD) characteristics of biosimilar SAR342434 insulin lispro and Japan-reference Humalog... (Randomized Controlled Trial)
Randomized Controlled Trial
This phase 1 study compared the pharmacokinetic (PK) and glucose pharmacodynamic (PD) characteristics of biosimilar SAR342434 insulin lispro and Japan-reference Humalog insulin lispro. This was a randomized, double-blind, 2-period, crossover study. Thirty-six healthy Japanese male subjects underwent a 10-hour euglycemic clamp following a single subcutaneous 0.3-U/kg dose of SAR342434 or Humalog. Insulin lispro concentration and blood glucose were measured, and the glucose infusion rate (GIR) was adjusted to maintain the target blood glucose level. Primary PK end points were maximum plasma insulin lispro concentration and area under the plasma insulin concentration-time curve (AUC) from time 0 to the last quantifiable concentration. Primary PD end points were area under the GIR-time curve from time 0 to 10 hours and maximum GIR. PK exposure (maximum plasma concentration and AUC from time 0 to the last quantifiable concentration) and PD activity (GIR-AUC from time 0 to 10 hours and maximum GIR) were similar between treatments. Geometric mean ratios were close to 1, and the corresponding 90% and 95%CIs (PK and PD activity, respectively) were within the 0.80 to 1.25 equivalence range. SAR342434 and Humalog were well tolerated. In healthy Japanese males, SAR342434 and Humalog showed similar PK exposure profiles and PD potency, in support of SAR342434 use as a biosimilar product.
Topics: Biosimilar Pharmaceuticals; Blood Glucose; Cross-Over Studies; Glucose; Humans; Hypoglycemic Agents; Insulin Lispro; Japan; Male
PubMed: 35166054
DOI: 10.1002/cpdd.1068 -
Diabetes/metabolism Research and Reviews Jan 2016The level of glycaemic control necessary to achieve optimal short-term and long-term outcomes in subjects with type 1 diabetes mellitus (T1DM) typically requires... (Comparative Study)
Comparative Study Review
The level of glycaemic control necessary to achieve optimal short-term and long-term outcomes in subjects with type 1 diabetes mellitus (T1DM) typically requires intensified insulin therapy using multiple daily injections or continuous subcutaneous insulin infusion. For continuous subcutaneous insulin infusion, the insulins of choice are the rapid-acting insulin analogues, insulin aspart, insulin lispro and insulin glulisine. The advantages of continuous subcutaneous insulin infusion over multiple daily injections in adult and paediatric populations with T1DM include superior glycaemic control, lower insulin requirements and better health-related quality of life/patient satisfaction. An association between continuous subcutaneous insulin infusion and reduced hypoglycaemic risk is more consistent in children/adolescents than in adults. The use of continuous subcutaneous insulin infusion is widely recommended in both adult and paediatric T1DM populations but is limited in pregnant patients and those with type 2 diabetes mellitus. All available rapid-acting insulin analogues are approved for use in adult, paediatric and pregnant populations. However, minimum patient age varies (insulin lispro: no minimum; insulin aspart: ≥2 years; insulin glulisine: ≥6 years) and experience in pregnancy ranges from extensive (insulin aspart, insulin lispro) to limited (insulin glulisine). Although more expensive than multiple daily injections, continuous subcutaneous insulin infusion is cost-effective in selected patient groups. This comprehensive review focuses on the European situation and summarises evidence for the efficacy and safety of continuous subcutaneous insulin infusion, particularly when used with rapid-acting insulin analogues, in adult, paediatric and pregnant populations. The review also discusses relevant European guidelines; reviews issues that surround use of this technology; summarises the effects of continuous subcutaneous insulin infusion on patients' health-related quality of life; reviews relevant pharmacoeconomic data; and discusses recent advances in pump technology, including the development of closed-loop 'artificial pancreas' systems. © 2015 The Authors. Diabetes/Metabolism Research and Reviews Published by John Wiley & Sons Ltd.
Topics: Blood Glucose; Computer Security; Diabetes Mellitus, Type 1; Europe; Evidence-Based Medicine; Health Care Costs; Humans; Hyperglycemia; Hypoglycemia; Hypoglycemic Agents; Infusions, Subcutaneous; Insulin Infusion Systems; Insulin, Short-Acting; Insulins; Monitoring, Ambulatory; Precision Medicine; Quality of Life
PubMed: 25865292
DOI: 10.1002/dmrr.2653 -
World Journal of Diabetes Mar 2015Gestational diabetes mellitus (GDM) is on the rise globally. In view of the increasing prevalence of GDM and fetal and neonatal complications associated with it, there... (Review)
Review
Gestational diabetes mellitus (GDM) is on the rise globally. In view of the increasing prevalence of GDM and fetal and neonatal complications associated with it, there is a splurge of research in this field and management of GDM is undergoing a sea change. Trends are changing in prevention, screening, diagnosis, treatment and future follow up. There is emerging evidence regarding use of moderate exercise, probiotics and vitamin D in the prevention of GDM. Regarding treatment, newer insulin analogs like aspart, lispro and detemir are associated with better glycemic control than older insulins. Continuous glucose monitoring systems and continuous subcutaneous insulin systems may play a role in those who require higher doses of insulin for sugar control. Evidence exists that favors metformin as a safer alternative to insulin in view of good glycemic control and better perinatal outcomes. As the risk of developing GDM in subsequent pregnancies and also the risk of overt diabetes in later life is high, regular assessment of these women is required in future. Lifestyle interventions or metformin should be offered to women with a history of GDM who develop pre-diabetes. Further studies are required in the field of prevention of GDM for optimizing obstetric outcome.
PubMed: 25789109
DOI: 10.4239/wjd.v6.i2.284 -
Journal of Diabetes Science and... Mar 2023We evaluated the effect of meloxicam on insulin lispro pharmacokinetics and glucose pharmacodynamics over 10 days of continuous subcutaneous insulin infusion (CSII) at... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
We evaluated the effect of meloxicam on insulin lispro pharmacokinetics and glucose pharmacodynamics over 10 days of continuous subcutaneous insulin infusion (CSII) at one infusion site in people with type 1 diabetes (T1D).
METHOD
This phase 1, randomized, double-blind, single-center, two-way crossover study enrolled adults with T1D for ≥1 year on stable CSII for ≥3 months. Participants randomly received U100 insulin lispro and LY900027 (U100 insulin lispro + 0.25 mg/mL meloxicam). Primary end points were area under the insulin lispro curve from 0 to 5 hours (AUC) after bolus administration prior to a mixed-meal tolerance test (MMTT) and maximum observed concentration of insulin lispro (C) on days 5, 7, and 10, versus day 3 (baseline).
RESULTS
A total of 20 participants were randomized. Insulin absorption was accelerated for insulin lispro and LY900027 from days 1 to 7. The AUC was significantly lower on day 10 versus day 3 for LY900027 (-19%) and insulin lispro (-14%); the AUC did not differ significantly between treatments. The C increased with LY900027 and insulin lispro (by ~14%-23% and ~16%-51%) on days 5, 7, and 10 versus day 3. The C of LY900027 was ~14%-23% lower than insulin lispro C on days 7 and 10 ( ≤ .0805). Accelerated insulin absorption and a modest loss of total insulin exposure led to a loss of MMTT glycemic control at later time points.
CONCLUSIONS
The pharmacokinetics of insulin changed over catheter wear time even when an anti-inflammatory agent was present. Postprandial glycemic control was adversely affected by the accelerated insulin absorption and decreased insulin exposure.
Topics: Adult; Humans; Insulin Lispro; Insulin; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Cross-Over Studies; Meloxicam; Blood Glucose; Insulin, Regular, Human
PubMed: 36575993
DOI: 10.1177/19322968221145200