The Experts below are selected from a list of 4026 Experts worldwide ranked by ideXlab platform
P D Home - One of the best experts on this subject based on the ideXlab platform.
-
anti Insulin antibodies and adverse events with biosimilar Insulin Lispro compared with humalog Insulin Lispro in people with diabetes
Diabetes Technology & Therapeutics, 2018Co-Authors: P D Home, Karlmichael Derwahl, Monika Ziemen, Karin Wernickepanten, Suzanne Pierre, Yvonne Kirchhein, S K GargAbstract:Abstract Background: SAR342434 (SAR-Lis) is a biosimilar (follow-on) of Insulin Lispro (Humalog®; Ly-Lis). Two randomized, controlled, open-label, parallel-group, phase 3 studies were conducted to compare the efficacy and safety of SAR-Lis and Ly-Lis, both in combination with Insulin glargine (Lantus®). SORELLA 1 was a 12-month study in 507 people with type 1 diabetes mellitus (T1DM); SORELLA 2 was a 6-month study in 505 people with type 2 diabetes mellitus (T2DM). In this study, the impact of anti-Insulin antibodies (AIA) to SAR-Lis and Ly-Lis on safety and glycemic control is reported. Methods: AIA were measured regularly throughout both studies at a centralized laboratory blinded to treatment groups using a drug-specific AIA assay. The AIA status (positive or negative), AIA titers, and cross-reactivity to human Insulin, Insulin glargine, and Insulin glargine metabolite M1 were analyzed. The potential effect of AIA on safety, particularly as related to hypersensitivity reactions, hypoglycemia, and treat...
-
treatment satisfaction and quality of life with Insulin glargine plus Insulin Lispro compared with nph Insulin plus unmodified human Insulin in individuals with type 1 diabetes
Diabetes Care, 2008Co-Authors: Simon Ashwell, Clare Bradley, James W Stephens, Elke Witthaus, P D HomeAbstract:Abstract Objective: To compare quality of life and treatment satisfaction when using Insulin glargine + Insulin Lispro with that on NPH Insulin + unmodified human Insulin in adults with Type 1 diabetes managed with multiple injection regimens. Research Design and Methods: As part of a 32-week, five-centre, two-way cross-over study in 56 people with Type 1 diabetes randomized to evening Insulin glargine + meal-time Insulin Lispro or to NPH Insulin (once- or twice-daily) + meal-time unmodified human Insulin, the Diabetes Treatment Satisfaction Questionnaire (DTSQ) and the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire were completed at baseline, weeks 16 and 32, with additional interim DTSQ measurements. Results: For all patients combined, mean baseline present quality of life (QoL) score was 1.3, reflecting ‘good’ QoL. Present QoL improved with glargine+Lispro but did not change with NPH+human Insulin (1.6±0.1 [±SE] vs 1.3±0.1, difference 0.3 (95 % CI 0.1, 0.6), p=0.014). Baseline mean average weighted impact score (AWI) of diabetes on QoL was –1.8, indicating a negative impact of diabetes on QoL. AWI score at endpoint improved significantly with glargine+Lispro but changed little with NPH+human Insulin (−1.4±0.1 vs −1.7±0.1, 0.3 (0.0, 0.6), p=0.033). Treatment satisfaction (DTSQ 36-0 scale score) at endpoint was markedly greater with glargine+Lispro compared with NPH+human Insulin (32.2±3.4 vs 23.9±7.2, 8.6 (6.5, 10.6), p Conclusions: Insulin glargine + Insulin Lispro improves treatment satisfaction, reduces the negative impact of diabetes on QoL and improves QoL, in comparison with NPH Insulin + unmodified human Insulin in Type 1 diabetes.
-
improved glycaemic control with Insulin glargine plus Insulin Lispro a multicentre randomized cross over trial in people with type 1 diabetes
Diabetic Medicine, 2006Co-Authors: Simon Ashwell, Rudy Bilous, S A Amiel, Umesh Dashora, Simon Heller, D A Hepburn, S D Shutler, J W Stephens, P D HomeAbstract:Aims To compare blood glucose control using Insulin glargine + Insulin Lispro with that on NPH Insulin + unmodified human Insulin in adults with Type 1 diabetes managed with a multiple injection regimen. Methods In this 32-week, five-centre, two-way cross-over study, people with Type 1 diabetes (n = 56, baseline HbA1c 8.0 ± 0.8%) were randomized to evening Insulin glargine + mealtime Insulin Lispro or to NPH Insulin (once- or twice-daily) + mealtime unmodified human Insulin. Each 16-week period concluded with a 24-h inpatient plasma glucose profile. Results HbA1c was lower with glargine + Lispro than with NPH + human Insulin [7.5 vs. 8.0%, difference −0.5 (95% CI −0.7, −0.3) %, P 7.0 mmol/l1 (47 vs. 62 mmol l−1 h−1, P = 0.017) and a 15% lower post-prandial plasma glucose AUC (75 vs. 88 mmol l−1 h−1, P = 0.002). There was no reduction in night-time plasma glucose AUC or increase in plasma glucose area < 3.5 mmol/l. Monthly rate of nocturnal hypoglycaemia was reduced by 44% with glargine + Lispro (0.66 vs. 1.18 episodes/month, P < 0.001). Conclusions Compared with NPH Insulin + unmodified human Insulin, the combination of Insulin glargine with a rapid-acting Insulin analogue as multiple-injection therapy for Type 1 diabetes improves overall glycaemic control as assessed by HbA1c and 24-h plasma glucose monitoring to a clinically significant degree, together with a reduction in nocturnal hypoglycaemia.
-
optimal timing of injection of once daily Insulin glargine in people with type 1 diabetes using Insulin Lispro at meal times
Diabetic Medicine, 2006Co-Authors: Simon Ashwell, Janice Gebbie, P D HomeAbstract:Aims To compare blood glucose control when Insulin glargine is given at lunch-time, dinner-time, and bed-time in people with Type 1 diabetes using Insulin Lispro at meal-times. Methods In this 16-week, three-way, cross-over study, 23 people with Type 1 diabetes were randomized to Insulin glargine injection at lunch-time (L) [mean 12.37 ± 00.34 (± sd) h], dinner-time (D) (18.12 ± 00.40 h), or bed-time (B) (22.29 ± 00.40 h), each plus meal-time Insulin Lispro. Each 4-week treatment period concluded with a 24-h inpatient metabolic profile. Results Insulin doses, HbA1c, and fructosamine concentration did not differ between treatment periods. Pre-breakfast self-monitored blood glucose (SMBG) concentration was higher with injection of glargine at lunch-time than at other times [L: 9.2 ± 0.3 (± se) vs. D: 8.2 ± 0.3 or B: 8.0 ± 0.3 mmol/l, P = 0.016], as probably was pre-lunch SMBG (L: 8.6 ± 0.7 vs. D: 6.4 ± 0.7 or B: 6.4 ± 0.8 mmol/l, P = 0.051). Pre-dinner SMBG level was higher with dinner-time glargine than other injection times (D: 9.4 ± 0.9 vs. L: 4.9 ± 0.9 or B: 7.4 ± 1.1 mmol/l, P = 0.007). For 22.00 to 02.00 h, mean inpatient plasma glucose concentration was higher with injection of glargine at bed-time than other times (B: 9.1 ± 0.6 vs. L: 7.8 ± 0.6 or D: 6.7 ± 0.6 mmol/l, P = 0.023). Plasma free Insulin concentration was lower at the end of the afternoon with dinner-time glargine than other injection times (D: 11.5 ± 1.4 vs. L: 20.2 ± 1.3 or B: 16.5 ± 1.3 mU/l, P < 0.001). Frequency of hypoglycaemia was not different, but timing of hypoglycaemia differed between treatment periods. Conclusions Blood glucose levels rise around the time of injection of Insulin glargine whether given at lunch-time, dinner-time or bed-time. Bed-time injection leads to hyperglycaemia in the early part of the night which is improved by giving Insulin glargine at lunch-time or dinner-time.
James H. Anderson - One of the best experts on this subject based on the ideXlab platform.
-
improvement of glycemic control and quality of life by Insulin Lispro therapy assessing benefits by itr qol questionnaires
Diabetes Research and Clinical Practice, 2008Co-Authors: Hitoshi Ishii, James H. Anderson, Ayuko Yamamura, Masakazu Takeuchi, Ichiro IkedaAbstract:Abstract Objective To investigate the impact of Insulin Lispro on patients’ quality of life (QOL) in diabetic patients who need Insulin treatment. Methods In this open-label, 12-week study 770 diabetic patients whose medications were switched to Insulin Lispro from human Insulin were evaluated. Main outcome measures were compliance with Insulin injection timing, HbA 1c , postprandial blood glucose, frequency and time of onset of hypoglycemia, and QOL measurements. Results After switching to Insulin Lispro, approximately 95% of patients “Always” or “Usually” complied with the timing of Insulin injections as instructed by their physician. HbA 1c was improved from 8.2 to 7.8% without increasing the number of hypoglycemic episodes. In terms of QOL, statistically significant improvements were observed in the Insulin-therapy-related QOL measure questionnaire (ITR-QOL) total score. Statistically significant correlations were found between compliance with Insulin injection timing and glycemic control, as well as glycemic control and QOL. Conclusion The improvement in patient convenience obtained by switching to Insulin Lispro provided better compliance with Insulin injection timing, and this in turn led to better glycemic control and improved QOL. Especially, a better QOL was seen to be clearly related with better glycemic control.
-
effect of long term exposure to Insulin Lispro on the induction of antibody response in patients with type 1 or type 2 diabetes
Diabetes Care, 2003Co-Authors: Edwin S Fineberg, Rocco L Brunelle, Jie Huang, K S Gulliya, James H. AndersonAbstract:OBJECTIVE —To determine the long-term effects of Insulin Lispro on inducing Lispro-specific, Insulin-specific, and cross-reactive (reactive with both Insulin Lispro and human Insulin) antibodies. RESEARCH DESIGN AND METHODS —A multinational, multicenter combination of controlled and noncontrolled, open-label studies of 4.5 years’ duration was designed to evaluate the long-term immunologic profile of subcutaneously administered Insulin Lispro. A total of 1,221 patients (men and women; 12–81 years of age) with type 1 or type 2 diabetes were enrolled. Circulating anti-Insulin antibodies were measured using radioimmunoassays. RESULTS —Insulin-specific and Lispro-specific antibody responses were within the background noise levels of the assays. Significant elevations of antibody were confined to a cross-reactive antibody response. Antibody levels resulting from prior exposure to long- and short-acting Insulins changed little after transfer to Insulin Lispro and remained within or near the baseline levels. De novo exposure to Insulin Lispro resulted in increases in cross-reactive but not Insulin- or Lispro-specific antibody levels. Cross-reactive Insulin antibodies developed more readily in patients with type 1 diabetes than in those with type 2 diabetes. Long-term antibody responses tended to decrease over time and returned to baseline or near-baseline levels by the end of the long-term studies. No evidence of an anamnestic antibody response could be found in individuals treated intermittently with Insulin Lispro. CONCLUSIONS —The immunogenic profile of patients treated with Insulin Lispro was comparable to that of patients treated with recombinant human Insulin. Inductions of significant levels of specific or cross-reactive antibodies were not observed in patients who had received Insulin previously. No significant antibody-dependent increases in Insulin dosage requirements were noted in these patients. The incidence of Insulin allergy was not different from that in patients treated with recombinant regular human Insulin.
-
improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel Insulin Lispro protamine formulations Insulin Lispro mix25 and Insulin Lispro mix50
Clinical Therapeutics, 1999Co-Authors: Paris Roach, Michael E. Trautmann, Vipin Arora, Bin Sun, James H. AndersonAbstract:The objective of this 6-month, open-label, randomized, two-period crossover study was to compare glycemic control when patients were treated with (1) 2 manufactured premixed Insulin formulations containing Insulin Lispro and a novel Insulin Lispro-protamine formulation, neutral protamine Lispro (NPL), and (2) 2 manufactured premixed human Insulin formulations, human Insulin 50/50 and human Insulin 30/70. One hundred individuals, 37 with type 1 diabetes mellitus (12 females, 25 males; mean age, 39.4 years; mean body mass index [BMI], 24.8; mean duration of diabetes, 12.9 years) and 63 with type 2 diabetes mellitus (33 females, 30 males; mean age, 59.0 years; mean BMI, 28.4; mean duration of diabetes, 12.6 years), were treated with Insulin Lispro mixtures. Insulin Lispro Mix50 (50% Insulin Lispro/50% NPL) and human Insulin 50/50 (50% regular Insulin/50% neutral protamine Hagedorn [NPH] Insulin) were administered before breakfast; Insulin Lispro Mix25 (25% Insulin Lispro/75% NPL) and human Insulin 30/70 (30% regular Insulin/70% NPH) were administered before dinner. Blood glucose (BG), hypoglycemic episodes (hypoglycemic signs or symptoms or BG <3.0 mmol/L), Insulin dose and timing of dose before meals, and hemoglobin A1c were measured. Mean doses of Insulin Lispro and human Insulin mixtures were similar overall and for both diabetes subgroups. However, compared with human Insulin mixtures, twice-daily administration of Insulin Lispro mixtures resulted in improved postprandial glycemic control, similar overall glycemic control, and less nocturnal hypoglycemia, as well as offering the convenience of dosing closer to meals.
-
Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel Insulin Lispro-protamine formulations, Insulin Lispro Mix25 and Insulin Lispro Mix50
Clinical Therapeutics, 1999Co-Authors: Paris Roach, Michael E. Trautmann, Vipin Arora, Bin Sun, James H. AndersonAbstract:The objective of this 6-month, open-label, randomized, two-period crossover study was to compare glycemic control when patients were treated with (1) 2 manufactured premixed Insulin formulations containing Insulin Lispro and a novel Insulin Lispro-protamine formulation, neutral protamine Lispro (NPL), and (2) 2 manufactured premixed human Insulin formulations, human Insulin 50/50 and human Insulin 30/70. One hundred individuals, 37 with type 1 diabetes mellitus (12 females, 25 males; mean age, 39.4 years; mean body mass index [BMI], 24.8; mean duration of diabetes, 12.9 years) and 63 with type 2 diabetes mellitus (33 females, 30 males; mean age, 59.0 years; mean BMI, 28.4; mean duration of diabetes, 12.6 years), were treated with Insulin Lispro mixtures. Insulin Lispro Mix50 (50% Insulin Lispro/50% NPL) and human Insulin 50/50 (50% regular Insulin/50% neutral protamine Hagedorn [NPH] Insulin) were administered before breakfast; Insulin Lispro Mix25 (25% Insulin Lispro/75% NPL) and human Insulin 30/70 (30% regular Insulin/70% NPH) were administered before dinner. Blood glucose (BG), hypoglycemic episodes (hypoglycemic signs or symptoms or BG
-
meta analysis of the effect of Insulin Lispro on severe hypoglycemia in patients with type 1 diabetes
Diabetes Care, 1998Co-Authors: B L Brunelle, James H. Anderson, J Llewelyn, E A Gale, Veikko A. KoivistoAbstract:OBJECTIVE A precise time-action profile of Insulin Lispro (Humalog) at mealtime may reduce the incidence of severe hypoglycemia. Because it is a rare complication, we performed a cumulative meta-analysis to compare the frequency of severe hypoglycemia during Insulin Lispro and human regular Insulin therapy in type 1 diabetic patients. RESEARCH DESIGN AND METHODS The analysis included eight large multicenter clinical trials, three with parallel and five with crossover designs. The studies included 2,576 type 1 diabetic patients in total, with 2,327 receiving Insulin Lispro and 2,339 receiving regular human Insulin, representing >1,400 patient-years of Insulin therapy. Severe hypoglycemia was defined as coma or requiring glucagon or intravenous glucose. The patients received either NPH or ultralente as their basal Insulin and Insulin Lispro or regular human Insulin before each meal. RESULTS Seventy-two patients (3.1%) had a total of 102 severe hypoglycemic episodes during Insulin Lispro therapy, compared with 102 patients (4.4%) with a total of 131 episodes during regular human Insulin therapy ( P = 0.024). CONCLUSIONS The results of this meta-analysis demonstrate that in type 1 diabetic patients, the frequency of severe hypoglycemia can be reduced by taking Insulin Lispro as compared with regular human Insulin therapy.
Matthew Dobson - One of the best experts on this subject based on the ideXlab platform.
-
economic evaluation of Insulin Lispro versus neutral regular Insulin therapy using a willingness to pay approach
PharmacoEconomics, 1998Co-Authors: Peter Davey, David Grainger, Narayan Rajan, Michael Aristides, Jamie Macmillan, Matthew DobsonAbstract:This willingness-to-pay (WTP) analysis is the first study of its kind undertaken in Australia to support an application for listing of a new drug on the Australian national formulary. The technique offers the advantage of being able to summarise diverse outcomes of therapy in a single unit of measure. Willingness to pay is used to value benefits in cost-benefit analysis (CBA), and CBA represents an absolute decision rule. An open-ended question with a bid-up approach was used to minimise bias and elicit the maximum amount patients would be willing to pay for Insulin Lispro. The WTP study incorporated scenarios describing the outcomes from Insulin Lispro and neutral (regular) Insulin, the results from a formal meta-analysis and a description of the injection characteristics of the therapies. A sample of 83 patients with type I or II diabetes mellitus were surveyed using an open questionnaire to determine their maximum willingness to pay for the therapy they preferred. Overall, 92% of patients preferred Insulin Lispro (referred to as Insulin A) and 8% preferred neutral Insulin (referred to as Insulin B). The incremental benefit per patient was calculated as 452.16 Australian dollars ($A) per year. Insulin Lispro was listed on the Australian national formulary at a 36% premium over neutral Insulin, so the additional cost per patient would be $A70.32 per year. Therefore, costs were exceeded by the benefits and Insulin Lispro was deemed to offer a net benefit. A multivariate analysis indicated that those patients who were middle-aged had the strongest preference for Insulin Lispro.
-
Economic Evaluation of Insulin Lispro versus Neutral (Regular) Insulin Therapy Using a Willingness—To—Pay Approach
PharmacoEconomics, 1998Co-Authors: Peter Davey, David Grainger, Narayan Rajan, Michael Aristides, Jamie Macmillan, Matthew DobsonAbstract:This willingness-to-pay (WTP) analysis is the first study of its kind undertaken in Australia to support an application for listing of a new drug on the Australian national formulary. The technique offers the advantage of being able to summarise diverse outcomes of therapy in a single unit of measure. Willingness to pay is used to value benefits in cost—benefit analysis (CBA), and CBA represents an absolute decision rule. An open—ended question with a bid—up approach was used to minimise bias and elicit the maximum amount patients would be willing to pay for Insulin Lispro. The WTP study incorporated scenarios describing the outcomes from Insulin Lispro and neutral (regular) Insulin, the results from a formal metaanalysis and a description of the injection characteristics of the therapies. A sample of 83 patients with type I or II diabetes mellitus were surveyed using an open questionnaire to determine their maximum willingness to pay for the therapy they preferred. Overall, 92% of patients preferred Insulin Lispro (referred to as Insulin A) and 8% preferred neutral Insulin (referred to as Insulin B). The incremental benefit per patient was calculated as 452.16 Australian dollars ($A) per year. Insulin Lispro was listed on the Australian national formulary at a 36% premium over neutral Insulin, so the additional cost per patient would be $A70.32 per year. Therefore, costs were exceeded by the benefits and Insulin Lispro was deemed to offer a net benefit. A multivariate analysis indicated that those patients who were middle—aged had the strongest preference for Insulin Lispro.
Peter Davey - One of the best experts on this subject based on the ideXlab platform.
-
Economic Evaluation of Insulin Lispro versus Neutral (Regular) Insulin Therapy Using a Willingness—To—Pay Approach
PharmacoEconomics, 1998Co-Authors: Peter Davey, David Grainger, Narayan Rajan, Michael Aristides, Jamie Macmillan, Matthew DobsonAbstract:This willingness-to-pay (WTP) analysis is the first study of its kind undertaken in Australia to support an application for listing of a new drug on the Australian national formulary. The technique offers the advantage of being able to summarise diverse outcomes of therapy in a single unit of measure. Willingness to pay is used to value benefits in cost—benefit analysis (CBA), and CBA represents an absolute decision rule. An open—ended question with a bid—up approach was used to minimise bias and elicit the maximum amount patients would be willing to pay for Insulin Lispro. The WTP study incorporated scenarios describing the outcomes from Insulin Lispro and neutral (regular) Insulin, the results from a formal metaanalysis and a description of the injection characteristics of the therapies. A sample of 83 patients with type I or II diabetes mellitus were surveyed using an open questionnaire to determine their maximum willingness to pay for the therapy they preferred. Overall, 92% of patients preferred Insulin Lispro (referred to as Insulin A) and 8% preferred neutral Insulin (referred to as Insulin B). The incremental benefit per patient was calculated as 452.16 Australian dollars ($A) per year. Insulin Lispro was listed on the Australian national formulary at a 36% premium over neutral Insulin, so the additional cost per patient would be $A70.32 per year. Therefore, costs were exceeded by the benefits and Insulin Lispro was deemed to offer a net benefit. A multivariate analysis indicated that those patients who were middle—aged had the strongest preference for Insulin Lispro.
-
economic evaluation of Insulin Lispro versus neutral regular Insulin therapy using a willingness to pay approach
PharmacoEconomics, 1998Co-Authors: Peter Davey, David Grainger, Narayan Rajan, Michael Aristides, Jamie Macmillan, Matthew DobsonAbstract:This willingness-to-pay (WTP) analysis is the first study of its kind undertaken in Australia to support an application for listing of a new drug on the Australian national formulary. The technique offers the advantage of being able to summarise diverse outcomes of therapy in a single unit of measure. Willingness to pay is used to value benefits in cost-benefit analysis (CBA), and CBA represents an absolute decision rule. An open-ended question with a bid-up approach was used to minimise bias and elicit the maximum amount patients would be willing to pay for Insulin Lispro. The WTP study incorporated scenarios describing the outcomes from Insulin Lispro and neutral (regular) Insulin, the results from a formal meta-analysis and a description of the injection characteristics of the therapies. A sample of 83 patients with type I or II diabetes mellitus were surveyed using an open questionnaire to determine their maximum willingness to pay for the therapy they preferred. Overall, 92% of patients preferred Insulin Lispro (referred to as Insulin A) and 8% preferred neutral Insulin (referred to as Insulin B). The incremental benefit per patient was calculated as 452.16 Australian dollars ($A) per year. Insulin Lispro was listed on the Australian national formulary at a 36% premium over neutral Insulin, so the additional cost per patient would be $A70.32 per year. Therefore, costs were exceeded by the benefits and Insulin Lispro was deemed to offer a net benefit. A multivariate analysis indicated that those patients who were middle-aged had the strongest preference for Insulin Lispro.
-
clinical outcomes with Insulin Lispro compared with human regular Insulin a meta analysis
Clinical Therapeutics, 1997Co-Authors: Peter Davey, David Grainger, Narayan Rajan, Michael Aristides, Jamie Macmillan, Michael GliksmanAbstract:Abstract We performed a meta-analysis to compare Insulin Lispro and human regular Insulin across a range of outcomes common in modern diabetes management to establish a basis for subsequent economic evaluation. We included all identifiable head-to-head randomized controlled trials, pooling dichotomous and continuous outcomes using appropriate statistical methods. Measures associated with various aspects of glycemic control (preprandial and postprandial glycemic control, glucose excursion, and glycated hemoglobin) and with hypoglycemia were evaluated. Results showed significant differences in favor of Insulin Lispro in the outcomes associated with postprandial glycemic control without an increase in hypoglycemia. Outcomes associated with fasting glycemic control and overall long-term glycemic control were not significantly different between Insulin Lispro and human regular Insulin. Alternative approaches to the meta-analysis were explored but did not alter the conclusions. Thus our meta-analysis supports the existence of significant differences between Insulin Lispro and human regular Insulin in terms of important postprandial outcome measures in diabetes. In addition, there is a practical differences in injection timing relative to meals: human regular Insulin should be administered 30 to 45 minutes before eating, whereas Insulin Lispro can be administered 15 minutes or less before eating. These differences should be the subject of an economic evaluation to assist in determining the place of Insulin Lispro in diabetes management.
Michael E. Trautmann - One of the best experts on this subject based on the ideXlab platform.
-
use of Insulin Lispro in continuous subcutaneous Insulin infusion treatment results of a multicenter trial german humalog csii study group
Diabetes Care, 1999Co-Authors: R Renner, Michael E. Trautmann, A Pfutzner, O Harzer, K Sauter, R LandgrafAbstract:OBJECTIVE: Insulin Lispro is an analog of human Insulin with a faster onset and a shorter duration of action than regular human Insulin. Efficacy and tolerability of Insulin Lispro in continuous subcutaneous Insulin infusion (CSII) treatment were assessed in an open randomized crossover trial comparing Insulin Lispro and regular human Insulin, both applied with Insulin pumps. RESEARCH DESIGN AND METHODS: A total of 113 type 1 patients (60 male, 53 female, age [mean +/- SD] 37 +/- 12 years, duration of diabetes 19 +/- 9 years) participated in this open, randomized crossover study. Both Insulins were applied for 4 months each with the appropriate intervals between the prandial Insulin bolus and the meal (human Insulin: 30 min; Lispro: 0 min). Observation parameters were HbA1c, daily and postprandial blood glucose profiles, adverse events, rate of hypoglycemic and hyperglycemic events, number of catheter obstructions, and treatment satisfaction as assessed with an international validated questionnaire. RESULTS: The patients were well controlled with a mean HBA1c of 7.24 +/- 1.0% at baseline. HbA1c decreased in both treatment periods, but it was better during Insulin Lispro treatment (Insulin Lispro: 6.8 +/- 0.9%, regular human Insulin: 6.9 +/- 1.0%, Friedman9s rank-sum test: P
-
improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel Insulin Lispro protamine formulations Insulin Lispro mix25 and Insulin Lispro mix50
Clinical Therapeutics, 1999Co-Authors: Paris Roach, Michael E. Trautmann, Vipin Arora, Bin Sun, James H. AndersonAbstract:The objective of this 6-month, open-label, randomized, two-period crossover study was to compare glycemic control when patients were treated with (1) 2 manufactured premixed Insulin formulations containing Insulin Lispro and a novel Insulin Lispro-protamine formulation, neutral protamine Lispro (NPL), and (2) 2 manufactured premixed human Insulin formulations, human Insulin 50/50 and human Insulin 30/70. One hundred individuals, 37 with type 1 diabetes mellitus (12 females, 25 males; mean age, 39.4 years; mean body mass index [BMI], 24.8; mean duration of diabetes, 12.9 years) and 63 with type 2 diabetes mellitus (33 females, 30 males; mean age, 59.0 years; mean BMI, 28.4; mean duration of diabetes, 12.6 years), were treated with Insulin Lispro mixtures. Insulin Lispro Mix50 (50% Insulin Lispro/50% NPL) and human Insulin 50/50 (50% regular Insulin/50% neutral protamine Hagedorn [NPH] Insulin) were administered before breakfast; Insulin Lispro Mix25 (25% Insulin Lispro/75% NPL) and human Insulin 30/70 (30% regular Insulin/70% NPH) were administered before dinner. Blood glucose (BG), hypoglycemic episodes (hypoglycemic signs or symptoms or BG <3.0 mmol/L), Insulin dose and timing of dose before meals, and hemoglobin A1c were measured. Mean doses of Insulin Lispro and human Insulin mixtures were similar overall and for both diabetes subgroups. However, compared with human Insulin mixtures, twice-daily administration of Insulin Lispro mixtures resulted in improved postprandial glycemic control, similar overall glycemic control, and less nocturnal hypoglycemia, as well as offering the convenience of dosing closer to meals.
-
Improved postprandial blood glucose control and reduced nocturnal hypoglycemia during treatment with two novel Insulin Lispro-protamine formulations, Insulin Lispro Mix25 and Insulin Lispro Mix50
Clinical Therapeutics, 1999Co-Authors: Paris Roach, Michael E. Trautmann, Vipin Arora, Bin Sun, James H. AndersonAbstract:The objective of this 6-month, open-label, randomized, two-period crossover study was to compare glycemic control when patients were treated with (1) 2 manufactured premixed Insulin formulations containing Insulin Lispro and a novel Insulin Lispro-protamine formulation, neutral protamine Lispro (NPL), and (2) 2 manufactured premixed human Insulin formulations, human Insulin 50/50 and human Insulin 30/70. One hundred individuals, 37 with type 1 diabetes mellitus (12 females, 25 males; mean age, 39.4 years; mean body mass index [BMI], 24.8; mean duration of diabetes, 12.9 years) and 63 with type 2 diabetes mellitus (33 females, 30 males; mean age, 59.0 years; mean BMI, 28.4; mean duration of diabetes, 12.6 years), were treated with Insulin Lispro mixtures. Insulin Lispro Mix50 (50% Insulin Lispro/50% NPL) and human Insulin 50/50 (50% regular Insulin/50% neutral protamine Hagedorn [NPH] Insulin) were administered before breakfast; Insulin Lispro Mix25 (25% Insulin Lispro/75% NPL) and human Insulin 30/70 (30% regular Insulin/70% NPH) were administered before dinner. Blood glucose (BG), hypoglycemic episodes (hypoglycemic signs or symptoms or BG
-
mealtime treatment with Insulin analog improves postprandial hyperglycemia and hypoglycemia in patients with non Insulin dependent diabetes mellitus multicenter Insulin Lispro study group
JAMA Internal Medicine, 1997Co-Authors: James H. Anderson, Michael E. Trautmann, Veikko A. Koivisto, Rocco L Brunelle, Louis Vignati, P Keohane, Richard D DimarchiAbstract:BACKGROUND Insulin Lispro is an Insulin analog that was recently developed particularly for a mealtime therapy. It has a fast absorption rate and short duration of action. The efficacy of Insulin Lispro in the clinical therapy of patients with non-Insulin-dependent diabetes mellitus (NIDDM) has not been tested. OBJECTIVES To compare Insulin Lispro and human regular Insulin in the mealtime treatment of patients with NIDDM. METHODS A 6-month, randomized, multinational (16 countries), multicenter (80 sites) clinical trial with an open-label, crossover design was performed in 722 patients with NIDDM. Insulin Lispro was injected immediately before and human regular Insulin 30 to 45 minutes before the meal. RESULTS Throughout the study, the postprandial rise in serum glucose levels was significantly lower during Insulin Lispro than human regular Insulin treatment. At end point the rise (mean +/- SEM) in serum glucose levels was 30% lower at 1 hour (2.6 +/- 0.1 mmol/L [46.8 +/- 1.8 mg/ dL] for Lispro vs 3.7 +/- 0.1 mmol/L [66.6 +/- 1.8 mg/dL] for human regular Insulin) and 53% lower 2 hours after the test meal (1.4 +/- 0.1 mmol/L [25.2 +/- 1.8 mg/dL] for Lispro vs 3.0 +/- 0.1 mmol/L [54.0 +/- 1.8 mg/dL] for human regular Insulin) with Insulin Lispro compared with human regular Insulin therapy (P < .001 for both intervals). During Insulin Lispro therapy the rate of hypoglycemia overall (P = .01) and overnight (P < .001) was lower and the number of asymptomatic hypoglycemic episodes was smaller (P = .03) than during human regular Insulin therapy. Associated with a similar 13% increase (P < .001) in the total daily Insulin dose, the glycosylated hemoglobin level decreased (P < .001) equally in both treatment groups. Serum lipid and lipoprotein levels remained unchanged. There were no differences in the adverse events between the 2 treatment groups. CONCLUSIONS Compared with human regular Insulin therapy, mealtime therapy with Insulin Lispro reduced postprandial hyperglycemia and may decrease the rate of mild hypoglycemic episodes in patients with NIDDM.
-
reduction of postprandial hyperglycemia and frequency of hypoglycemia in iddm patients on Insulin analog treatment multicenter Insulin Lispro study group
Diabetes, 1997Co-Authors: James H. Anderson, Michael E. Trautmann, Veikko A. Koivisto, A Pfutzner, Rocco L Brunelle, Louis Vignati, Richard D DimarchiAbstract:Insulin Lispro, an Insulin analog recently developed particularly for mealtime therapy, has a fast absorption rate and a short duration of action. We compared Insulin Lispro and regular human Insulin in the mealtime treatment of 1,008 patients with IDDM. The study was a 6-month randomized multinational (17 countries) and multicenter (102 investigators) clinical trial performed with an open-label crossover design. Insulin Lispro was injected immediately before the meal, and regular human Insulin was injected 30-45 min before the meal. Throughout the study, the postprandial rise in serum glucose was significantly lower during Insulin Lispro therapy. At the endpoint, the postprandial rise in serum glucose was reduced at 1 h by 1.3 mmol/l and at 2 h by 2.0 mmol/l in patients treated with Insulin Lispro (P < 0.001). The rate of hypoglycemia was 12% less with Insulin Lispro (6.4 +/- 0.2 vs. 7.2 +/- 0.3 episodes/30 days, P < 0.001), independent of basal Insulin regimen or HbA1c level. The reduction was observed equally in episodes with and without symptoms. When the total number of episodes for each patient was analyzed according to the time of occurrence, the number of hypoglycemic episodes was less with Insulin Lispro than with regular human Insulin therapy during three of four quarters of the day (P < 0.001). The largest relative improvement was observed at night. In conclusion, Insulin Lispro improves postprandial control, reduces hypoglycemic episodes, and improves patient convenience, compared with regular human Insulin, in IDDM patients.