Our library of drug research abstracts drawn from the medical literature is updated on a regular schedule, and you can be assured that new humalog research articles will be listed here shortly after becoming available to us.
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Medical research on humalog
J Pediatr. 2008 Jun 25;
Chase HP, Arslanian S, White NH, Tamborlane WV
OBJECTIVES: To compare long-acting insulin glargine (Lantus) with intermediate-acting insulin (neutral protamine Hagedorn [NPH]/Lente) when used as the basal component of a multiple daily injection (MDI) regimen with prandial insulin lispro (Humalog) in adolescents with type 1 diabetes mellitus (T1DM). STUDY DESIGN: This was an active-controlled, randomized, open-label, sex-stratified, 2-arm, parallel-group comparison of once-daily insulin glargine with twice-daily NPH/Lente in an MDI regimen. Changes in glycated hemoglobin A1C (A1C), occurrence of hypoglycemia, and adverse events were assessed in 175 patients (age 9 to 17 years) with T1DM. RESULTS: The overall mean change in A1C from baseline to week 24 was similar in the 2 groups: insulin glargine (n = 76), -0.25% +/- 0.14%; NPH/Lente (n = 81), 0.05% +/- 0.13% (P = .1725). However, an analysis of covariance, adjusting for baseline A1C, revealed a strong study arm effect on the slopes of the regression lines, indicating that the reduction in A1C was significantly greater with insulin glargine in those patients with higher baseline A1C values. The rate of confirmed glucose values
Achieving better outcomes in pregnancies complicated by type 1 and type 2 diabetes mellitus.
Clin Ther. 2007; 29 Suppl D: S153-60
Kinsley B
BACKGROUND: Pregnancy in type 1 and type 2 diabetes mellitus (DM) is associated with an increased rate of adverse outcomes for both mother and fetus. OBJECTIVE: This article reviews the data available on achieving better outcomes in pregnancies complicated by DM. METHODS: Background materials for this article were gathered based on a PubMed search of English-language articles (up to and including August 2007) using the search terms diabetes mellitus, pregnancy, glycemic control, mortality, and morbidity. This review article was based on a presentation given at a satellite symposium entitled "Realising the Value of Modern Insulins: Reaching Further with Rapid-Acting Insulin Analogues" that was convened during the XIXth World Diabetes Congress, December 3, 2006, in Cape Town, South Africa. RESULTS: There is clear evidence that optimized metabolic control, from preconception through pregnancy, can reduce the risk of maternal and fetal complications in women with DM. The risk of fetal congenital abnormalities in pregnant women with DM is intricately related to the level of glycemic control in early pregnancy; thus, strict metabolic targets as close to normal glycosylated hemoglobin (HbA1c) (ie, 4.0%-6.0%) as possible are recommended. However, these HbA1c and postprandial plasma glucose targets are challenging for the physician and the patient. The rapid-acting insulin analogues, insulin aspart and insulin lispro, may be useful because they can reduce postprandial hyperglycemia without increasing the risk for hypoglycemia and even provide a small improvement in HbA1c compared with regular human insulin. In a recent, prospective, randomized controlled study of pregnant women with type 1 DM (N=322), maternal hypoglycemia, metabolic control, and tolerability, including perinatal outcomes, were compared between those randomized to mealtime insulin aspart or human insulin. The results from this study suggest that insulin aspart is at least as effective and well tolerated as human insulin in basal-bolus therapy with neutral protamine Hagedorn insulin. Overall, 80% of study participants in both groups achieved HbA1c levels
Clin Ther. 2007; 29 Suppl D: S135-44
Bode BW
BACKGROUND: Replicating endogenous insulin production is the goal of treatment for diabetes mellitus (DM) and is necessary to minimize the risk of vascular complications. The 2 main methods of achieving this goal are continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDIs) comprising basal and prandial injections. OBJECTIVE: The objective of this article was to discuss the use of a rapid-acting insulin analogue, insulin aspart, in CSII and MDI compared with other insulins in adult patients with type 1 or type 2 DM. METHODS: This article was based on a presentation given by the author at a satellite symposium entitled "Realising the Value of Modern Insulins: Reaching Further with Rapid-Acting Insulin Analogues" that was convened during the XIXth World Diabetes Congress, December 3, 2006, in Cape Town, South Africa. RESULTS: In patients with type 1 DM, CSII using the rapid-acting insulin analogue insulin aspart has been reported in clinical trials to improve glycemic control compared with MDI therapy using neutral protamine Hagedorn plus insulin aspart (for basal and mealtime coverage, respectively). In patients with type 2 DM, the CSII and MDI regimens offered similar efficacy and tolerability; CSII therapy may be less burdensome, however, with fewer social limitations than MDIs. Not all insulins are equally suited for use in CSII treatment. Although the efficacy of insulin aspart in CSII was comparable to other rapid-acting insulins, the frequency of hypoglycemia was shown to be significantly lower with insulin aspart compared with human insulin or insulin lispro in patients with type 1 DM. The compatibility of insulin aspart and insulin lispro for use in CSII pumps was compared in an 8-week, double-blind, 2-period, crossover study of patients with type 1 DM. The overall adverse-effect score was significantly lower (P
J Chromatogr A. 2008 May 1;
Ho EN, Wan TS, Wong AS, Lam KK, Stewart BD
Insulin administration can increase muscle glycogen by utilising hyperinsulinaemic clamps prior to sports events or during the recovery phases, and increase muscle size by its chalonic action to inhibit protein breakdown. In order to control insulin abuse in equine sports, a method to detect effectively the use of insulins in horses would be required. Besides the readily available human insulin and its synthetic analogues, structurally similar insulins from other species can also be used as doping agents. This study describes a method for the simultaneous detection of bovine, porcine and human insulins, as well as the synthetic analogues Humalog (Lilly) and Novolog (Novo Nordisk) in equine plasma. Insulins were isolated from equine plasma by immunoaffinity purification, followed by centrifugal filtration, and analysed by nano-liquid chromatography-tandem mass spectrometry (LC/MS/MS). Insulin and analogues were detected and confirmed by comparing their retention times and major product ions. All five insulins (human insulin, Humalog, Novolog, bovine insulin and porcine insulin), which are exogenous in the horse, could be detected and confirmed at 0.05ng/mL. This method was successful in confirming the presence of human insulin in plasma collected from horses up to 4h after having been administered a single low dose of recombinant human insulin (Humulin R, Eli Lilly). To our knowledge, this is the first identification of exogenous insulin from post-administration horse plasma samples.
Diabetes Res Clin Pract. 2008 May 19;
Ishii H, Anderson JH, Yamamura A, Takeuchi M, Ikeda I
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.
Diabetes Obes Metab. 2008 May 20;
Masuda H, Sakamoto M, Irie J, Kitaoka A, Shiono K, Inoue G, Atsuda K, Yamada S
Objective: The aim of this study was to evaluate twice-daily injections of biphasic insulin lispro vs. basal-bolus (BB) therapy with regard to quality-of-life (QOL) and glycaemic control in insulin-naïve type 2 diabetic patients. Methods: Twenty-eight patients with type 2 diabetes were randomized to receive either twice-daily 50/50 premixed insulin lispro (Mix50 group) or BB (NPH insulin at bedtime and preprandial insulin lispro) therapy (BB group) for 12 weeks. Glycated haemoglobin (HbA1C), 1,5-anhydroglucitol (1,5-AG), blood plasma glucose level, body mass index (BMI), daily total insulin dosage and insulin therapy-related QOL (ITR-QOL) were studied. Results: ITR-QOL was significantly better in the Mix50 than in the BB group (103.1 +/- 9.8 vs. 90.6 +/- 19.4; p < 0.05). HbA(1c) improved in both groups (from 11.1 +/- 2.1 to 6.9 +/- 1.0% with Mix50 vs. from 11.0 +/- 2.3 to 6.6 +/- 0.8% with BB therapy). Conclusion: These results might suggest that twice-daily injections of premixed rapid-acting insulin analogue therapy could achieve good glycaemic control and better QOL compared with BB therapy in insulin-naïve type 2 diabetes.
Int J Clin Pract. 2008 Jul; 62(7): 1026-32
Reviriego J, Gomis R, Marañés JP, Ricart W, Hudson P, Sacristán JA
OBJECTIVES: To determine the costs of severe hypoglycaemia (SH) in a population of patients with type 1 diabetes mellitus in the Spanish healthcare system and the cost-effectiveness of insulin lispro over regular insulin in preventing SH episodes. METHODS: A retrospective study of 100 patients in three Spanish health centres was performed. Resource utilisation data were collected only for interventions specifically relating to the hypoglycaemic episode. The direct medical costs determined in the analyses were: costs of hospitalisation, diagnostic tests carried out, costs of treatment administered and other associated costs such as visits to the endocrinologist and re-training in glucose control, transportation and assistance of a care-giver. In addition, indirect costs such as days of lost productivity were measured. The incidence rates of SH for insulin lispro and regular insulin were obtained from the literature. The incremental cost-effectiveness of insulin lispro over regular insulin was calculated. RESULTS: The overall mean cost per episode of SH was 366 euro, comprised of 65.4% direct costs and 35.6% indirect costs. The largest cost was for hospitalisation at 183 euro per episode. The SH episodes incidence rates for 100 patients per year were 33 and 73 for insulin lispro and 48 (p < 0.05) and 117 (p < 0.01) for regular insulin, in the two clinical trials found in the literature. The additional cost to prevent one episode of SH with insulin lispro over regular insulin ranged from 277 euro to insulin lispro dominance. CONCLUSIONS: Severe hypoglycaemia has a significant impact on the total cost of diabetes. The use of insulin lispro is associated with reductions in annual costs because of SH and, possibly, the overall effect may be cost neutral or cost saving when total costs are considered. The cost of SH should be included in the analysis of total socio-economic burden of diabetes.
Insulin analog preparations and their use in children and adolescents with type 1 diabetes mellitus.
Paediatr Drugs. 2008; 10(3): 163-76
Miles HL, Acerini CL
Standard or 'traditional' human insulin preparations such as regular soluble insulin and neutral protamine Hagedorn (NPH) insulin have shortcomings in terms of their pharmacokinetic and pharmacodynamic properties that limit their clinical efficacy. Structurally modified insulin molecules or insulin 'analogs' have been developed with the aim of delivering insulin replacement therapy in a more physiological manner. In the last 10 years, five insulin analog preparations have become commercially available for clinical use in patients with type 1 diabetes mellitus: three 'rapid' or fast-acting analogs (insulin lispro, aspart, and glulisine) and two long-acting analogs (insulin glargine and detemir). This review highlights the specific pharmacokinetic properties of these new insulin analog preparations and focuses on their potential clinical advantages and disadvantages when used in children and adolescents with type 1 diabetes mellitus. The fast-acting analogs specifically facilitate more flexible insulin injection timing with regard to meals and activities, whereas the long-acting analogs have a more predictable profile of action and lack a peak effect. To date, clinical trials in children and adolescents have been few in number, but the evidence available from these and from other studies carried out in adults with type 1 diabetes suggest that they offer significant benefits in terms of reduced frequency of nocturnal hypoglycemia, better postprandial blood glucose control, and improved quality of life when compared with traditional insulins. In addition, insulin detemir therapy is unique in that patients may benefit from reduced risk of excessive weight, particularly during adolescence. Evidence for sustained long-term improvements in glycosylated hemoglobin, on the other hand, is modest. Furthermore, alterations to insulin/insulin-like growth factor I receptor binding characteristics have also raised theoretical concerns that insulin analogs may have an increased mitogenic potential and risk of tumor development, although evidence from both in vitro and in vivo animal studies do not support this assertion. Long-term surveillance has been recommended and further carefully designed prospective studies are needed to evaluate the overall benefits and clinical efficacy of insulin analog therapy in children and adolescents with type 1 diabetes.
Lancet. 2008 Mar 29; 371(9618): 1073-84
Bretzel RG, Nuber U, Landgraf W, Owens DR, Bradley C, Linn T
BACKGROUND: As type 2 diabetes mellitus progresses, oral hypoglycaemic agents often fail to maintain blood glucose control and insulin is needed. We investigated whether the addition of once-daily insulin glargine is non-inferior to three-times daily prandial insulin lispro in overall glycaemic control in adults with inadequately controlled type 2 diabetes mellitus taking oral hypoglycaemic agents. METHODS: In the 44-week, parallel, open study that was undertaken in 69 study sites across Europe and Australia, 418 patients with type 2 diabetes mellitus that was inadequately controlled by oral hypoglycaemic agents were randomly assigned to either insulin glargine taken once daily at the same time every day or to insulin lispro administered three times per day. The primary objective was to compare the change in haemoglobin A(1c) from baseline to endpoint (week 44) between the two regimens. Randomisation was done with a central randomisation service. Analysis was per protocol. This study is registered with ClinicalTrials.gov, number NCT00311818. FINDINGS: 205 patients were randomly assigned to insulin glargine and 210 to insulin lispro. Mean haemoglobin A(1c) decrease in the insulin glargine group was -1.7% (from 8.7% [SD 1.0] to 7.0% [0.7]) and -1.9% in the insulin lispro group (from 8.7% [1.0] to 6.8% [0.9]), which was within the predefined limit of 0.4% for non-inferiority (difference=0.157; 95% Cl -0.008 to 0.322). 106 (57%) patients reached haemoglobin A(1c) of 7% or less in the glargine group and 131 (69%) in the lispro group. In the glargine group, the fall in mean fasting blood glucose (-4.3 [SD 2.3] mmol/L vs -1.8 [2.3] mmol/L; p
Patient-centred treatments for type 2 diabetes.
Lancet. 2008 Mar 29; 371(9618): 1047-8
Kudva YC, Montori VM