Pseudomembranous colitis, a complication of erythromycin and preterm prelabour rupture of membranes.
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Adult↗
Biomedical subjects
V Arora
Publications and source records attributed to V Arora.
An investigation of the relationship between raw coal characteristics and effluent quality of Kedla and Rajrappa Washeries, Jharkhand, India.
An attempt was made to investigate the relationship between raw coal characteristics and effluent quality in two coking coal washeries of Central Coalfields Limited, Kedla and Rajrappa in Jharkhand State, India. Coal samples-raw coal feed, washed fine clean coal, washed coarse clean coal, middlings and rejects were collected. Similarly, raw water (intake to washery) and effluent samples generated in the washeries, namely, fine coal jig under water, coarse coal jig under water and slurry pond water were also collected over a period of 6 months. Parameters outlined in Ministry of Environment and Forest (MoEF) Schedule VI Indian standards were determined, both in coal samples and water/washery effluent samples. Apart from the parameters listed in the standard, sodium, potassium, calcium, magnesium, sulphate and chloride found to be present in coal were also determined in coal and water samples. The processing results essentially in production of huge quantities of suspended material, which is beyond the stipulated limit of 100mg/l as specified in the Standard. Lowering of pH was observed in both the washeries. The trace/heavy elements were found to be concentrated in the heavier fractions in rejects produced from the washery. The concentrations of major elements in coal-Na, K, Ca, Mg, and minor elements in coal-Mn; F, SO4 and Cl were found to be higher in process water than in raw water indicating that these elements are transferred from coal to the water in washeries. However, only in the case of Mn, the stipulated limit of the effluent standard was exceeded. Trace elements like As, Se, Hg, Cd, though found to be present in coal, were absent in the process water indicating that these elements are not released by coal during washing.
Coal↗
Communication failures in patient sign-out and suggestions for improvement: a critical incident analysis.
BACKGROUND: The transfer of care for hospitalized patients between inpatient physicians is routinely mediated through written and verbal communication or "sign-out". This study aims to describe how communication failures during this process can lead to patient harm. METHODS: In interviews employing critical incident technique, first year resident physicians (interns) described (1) any adverse events or near misses due to suboptimal preceding patient sign-out; (2) the worst event due to suboptimal sign-out in which they were involved; and (3) suggestions to improve sign-out. All data were analyzed and categorized using the constant comparative method with independent review by three researchers. RESULTS: Twenty six interns caring for 82 patients were interviewed after receiving sign-out from another intern. Twenty five discrete incidents, all the result of communication failures during the preceding patient sign-out, and 21 worst events were described. Inter-rater agreement for categorization was high (kappa 0.78-1.00). Omitted content (such as medications, active problems, pending tests) or failure-prone communication processes (such as lack of face-to-face discussion) emerged as major categories of failed communication. In nearly all cases these failures led to uncertainty during decisions on patient care. Uncertainty may result in inefficient or suboptimal care such as repeat or unnecessary tests. Interns desired thorough but relevant face-to-face verbal sign-outs that reviewed anticipated issues. They preferred legible, accurate, updated, written sign-out sheets that included standard patient content such as code status or active and anticipated medical problems. CONCLUSION: Communication failures during sign-out often lead to uncertainty in decisions on patient care. These may result in inefficient or suboptimal care leading to patient harm.
Chicago↗
Humalog Mix50 before carbohydrate-rich meals in type 2 diabetes mellitus.
AIM: To compare pre-meal injection of Humalog Mix50 (Mix50) and Humalog Mix25 (Humalog Mix75/25 in the US; Mix25) with respect to 2 h postprandial (2 h pp) blood glucose (BG) control after a carbohydrate-rich breakfast in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: One hundred and sixteen patients were enrolled in a 16-week crossover trial and received two treatment regimens in a randomized crossover fashion: (i) Mix50 before breakfast and Mix25 before the evening meal (Mix50/Mix25) and (ii) Mix25 before both breakfast and the evening meal (Mix25 twice daily). Insulin doses were adjusted according to stated glycaemic targets. After 6 and 8 weeks of treatment, the patient's usual morning insulin dose was administered, followed immediately by a test breakfast representative of the patient's usual breakfast meal. Fasting and 2 h pp BG concentrations were measured at the time of the test meal. Haemoglobin A1c (A1C) was measured, and information regarding hypoglycaemia (symptoms) was collected at the end of each treatment period. RESULTS: Insulin doses were similar between treatments (morning = 31-33 U, evening = 26-28 U) at endpoint. Following the test breakfast, the 2 h pp BG was lower (10.9 +/- 0.3 mmol/l vs. 12.4 +/- 0.3 mmol/l, p = 0.0012) and the 2 h pp BG excursion was smaller (1.4 +/- 0.28 mmol/l vs. 3.5 +/- 0.28 mmol/l, p < 0.001) during treatment with Mix50/Mix25 than during treatment with Mix25 twice daily. There was no difference between the treatments with respect to fasting BG (Mix50/Mix25, 9.5 +/- 0.3 mmol/l vs. Mix25 twice daily, 8.9 +/- 0.3 mmol/l; p = NS), A1C (8.14% +/- 1.14% vs. 8.14% +/- 1.07%; p = NS) or the incidence of self-reported hypoglycaemia (34% vs. 23%; p = NS). CONCLUSIONS: Compared with treatment with Mix25 twice daily, treatment with Mix50 before breakfast and Mix25 before the evening meal resulted in better pp glycaemic control following a carbohydrate-rich meal, and similar fasting BG, A1C and incidence of hypoglycaemia in patients with type 2 diabetes.
Adult↗
Humalog Mix25 improves 24-hour plasma glucose profiles compared with the human insulin mixture 30/70 in patients with type 2 diabetes mellitus.
OBJECTIVE: To compare the effects of Humalog Mix25 (Humalog Mix75/25 in the USA) (Mix25) and human insulin 30/70 (30/70) on the 24-hour inpatient plasma glucose (PG) profile in patients with type 2 diabetes mellitus (T2DM). DESIGN: A randomised, open-label, 8-week crossover study. Study insulins were injected twice daily, 5 minutes before breakfast and dinner. SETTING: Four-week outpatient (dose-adjustment) treatment phase, and 3-day inpatient (test) phase. PATIENTS: Twenty-five insulin-treated patients with T2DM (ages 40-66 years), mean (+/- standard error of the mean) (SEM) HbA1c 7.7% +/- 0.23%, and body mass index (BMI) 29.3 +/- 0.83 kg/m2. OUTCOME MEASURES: 24-hour PG profiles, PG excursions after meals, PG area under the curve (AUC), and 30-day hypoglycaemia rate. RESULTS: The 2-hour PG excursions following breakfast (5.5 +/- 0.34 v. 7.2 +/- 0.34 mmol/l, p = 0.002) and dinner (2.4 +/- 0.27 v. 3.4 +/- 0.27 mmol/l, p = 0.018) were smaller with Mix25 than with 30/70. PG AUC between breakfast and lunch was smaller with Mix25 than with 30/70 (77.6 +/- 3.8 v. 89.5 +/- 4.3 mmol/h/ml, p = 0.001). PG AUC between lunch and dinner, dinner and bedtime, and bedtime and breakfast did not differ between treatments. Pre-meal and nocturnal PG were comparable. The postprandial insulin requirement for lunch meals was supplied equally by the two insulin treatments. The thirty-day hypoglycaemia rate was low (Mix25 0.049 +/- 0.018 v. 30/70 0.100 +/- 0.018 episodes/patient/30 days, p = 0.586) for both treatments. CONCLUSION: In patients with T2DM, Mix25 improved the 24-hour PG profile with lower postprandial PG excursions than with human insulin 30/70.
Adult↗
Preliminary survey of leptospirosis amongst febrile patients from urban slums of East Delhi.
AIM: To determine the possibility of leptospirosis among patients from urban slums presenting with febrile illness during monsoon and post-monsoon season. METHODS: Evidence of leptospirosis in 180 patients with febrile illness was determined by looking for presence of immunoglobulin M (IgM) antibodies by leptospiral IgM enzyme linked immunosorbent assay (ELISA). The test was carried out on 160 Widal test negative and 20 Widal test positive sera received from febrile patients during June to September 2001. RESULTS: Twenty-seven out of 180 (15%) sera were positive for leptospiral IgM antibodies. CONCLUSIONS: This preliminary survey indicates that leptospirosis could be an important cause of febrile illness in patients from urban slums during monsoon and post-monsoon season.
Fever↗
Basal-bolus insulin therapy in Type 1 diabetes: comparative study of pre-meal administration of a fixed mixture of insulin lispro (50%) and neutral protamine lispro (50%) with human soluble insulin.
AIMS: To ascertain whether pre-meal administration of 50% insulin lispro and 50% neutral protamine lispro (NPL), given as a fixed mixture (Humalog Mix50, human soluble (regular) insulin as a basal-bolus regimen in people with Type 1 diabetes. Both regimens included bedtime human isophane (NPH) insulin. METHODS: This was a multinational, multicentre, randomized, open-label, two-period crossover comparison of two insulin treatments for two 12-week periods in 109 patients with Type 1 diabetes. The protocol provided preliminary evaluations of dose requirements and recommendations for insulin dose adjustment when switching regimens on the basis of blood glucose (BG) values. Eight-point BG profiles, frequency of hypoglycaemia, HbA1c, insulin dose, time of injection, and frequency of snacking were assessed during each treatment. RESULTS: Total daily insulin dose was similar for both treatments, but the total pre-meal doses were higher (P < 0.001) and the bedtime dose of isophane was lower (P < 0.001) with Mix50. The pre-meal dose before breakfast and lunch, although statistically different (P = 0.006 and P < 0.001, respectively), was of similar magnitude, but the pre-evening meal dose was higher with Mix50 (P < 0.001). Median (interquartile range) time of insulin injection before meals was: Mix50 4.2 (25th percentile = 1.0; 75th percentile = 6.3) min, human soluble insulin 24.6 (25th percentile = 16.6; 75th percentile = 30.0) min. Pre-meal and bedtime BG concentrations did not differ between treatments. The BG 2 h after the evening meal was lower with Mix50 (8.40 +/- 2.95 mmol/l vs. 9.60 +/- 3.47 mmol/l) (P = 0.049). BG after breakfast and lunch, mean HbA1c, frequency of hypoglycaemia, frequency of snacks, and body weight were not different. CONCLUSION: The use of Mix50 in a basal-bolus regimen achieved similar control of pre-meal BG to human soluble insulin, and overall glycaemic control and hypoglycaemia risk were equivalent. This suggests that Mix50 can provide an adequate supply of insulin to control BG between meals while providing the convenience of injecting immediately before meals.
Adult↗
Effects of a fixed mixture of 25% insulin lispro and 75% NPL on plasma glucose during and after moderate physical exercise in patients with type 2 diabetes.
OBJECTIVE: To compare the plasma glucose (PG) response with a fixed mixture of 25% insulin lispro and 75% NPL (Mix25), prior to a meal and 3 h before exercise, to human insulin 30/70 (30/70) in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS: Thirty-seven patients were treated in a randomized, open-label, 8-week, two-period crossover study. Mix25 was injected 5 min before breakfast and dinner throughout the study, as was 30/70 on inpatient test days and on outpatient dose titration days. Following the 4-week outpatient phase, patients were hospitalized, and exercised at a heart rate of 120 beats/min on a cycle ergometer two times for 30 min, separated by 30 min rest, starting 3 h after a 339 kcal breakfast. RESULTS: The 2-h postprandial PG was significantly lower with Mix25 ((mean +/- SEM) 10.5 +/- 0.4 mmol/l vs 11.6 +/- 0.4 mmol/l; p = 0.016). Maximum decrease in PG from onset of exercise to end of exercise was significantly less with Mix25 (-3.6 +/- 0.29 mmol/l vs -4.7 +/- 0.31 mmol/l; p = 0.001). The maximum decrease in PG over 6 h, after exercise onset, was significantly less with Mix25 (-4.3 +/- 0.4 mmol/l vs -5.9 +/- 0.4 mmol/l; p < 0.001). The frequency of hypoglycemia (blood glucose (BG) < 3 mmol/l or symptoms) during the inpatient test was not different between treatments. During the outpatient phase, the frequency of patient-recorded hypoglycemia was significantly lower with Mix25 (0.7 +/- 0.2 episodes/30 d vs 1.2 +/- 0.3 episodes/30 d; p = 0.042). CONCLUSIONS: Mix25 resulted in better postprandial PG control without an increase in exercise-induced hypoglycemia. The smaller decrease in PG during the postprandial phase after exercise may suggest a lower risk of exercise-induced hypoglycemia with Mix25 than with human insulin 30/70, especially for patients in tight glycemic control.
Adult↗
Fetal gastrointestinal malformations.
In an audit to evaluate fetal gastrointestinal (GIT) malformations, case sheets of all mothers who gave birth to newborns with GIT malformations were analysed regarding the maternal history, prenatal ultrasound and the postnatal structural malformations and perinatal management. In 1999, eleven babies were born with gastrointestinal malformations, one was a still birth. Nine had associated malformations of other systems, two had trisomy 21. Eight babies were operated in the immediate newborn period, 5 survived. Ultrasound was not very accurate in the diagnosis of GIT anomaly in this series. In view of associated chromosomal and structural anomaly a fetal ECHO and genetic amniocentesis is warranted. Most of these babies require immediate surgery after birth, so they need to be delivered in a centre which is equipped with good neonatal and pediatric surgery care.
Adult↗
Laparoscopic surgery in hepatic hydatid cysts: a technical improvement.
Hepatic hydatid cysts are a common surgical problem that is encountered in many tropical countries, including India. Open surgical exploration and excision had been the mainstay of treatment until the advent of laparoscopy. In 1998, we successfully managed six cases of large hepatic hydatid cysts using the videoendoscope, with excellent postoperative follow-up results. Four men and two women participated in this study, with patient ages ranging from 28 to 42 years. The duration of the disease ranged from 1.3 to 2.8 years. All patients had undergone preoperative albendazole therapy for more than 2 months. Complete evacuation of the cyst contents, including all daughter cysts and laminated membrane, along with a subtotal excision of the extrahepatic part of the cyst wall, was accomplished without any spillage into the peritoneal cavity. The saucerized cavity was drained. The drains were removed 6 to 9.4 days after a check ultrasound. Postoperative follow-up ranged from 3 to 9 months and revealed no evidence of a recurrence in the abdomen. It is possible with carefully planned placement of trocars to completely eliminate the risk of spillage, and therefore not compromise the standard principles of hydatid surgery.
Adult↗
Improved glycaemic control with the use of self-prepared mixtures of insulin lispro and insulin lispro protamine suspension in patients with types 1 and 2 diabetes.
A total of 166 patients (102 type 1, 64 type 2) were randomised to insulin lispro (LP) combined with insulin lispro protamine suspension (NPL), an intermediate-acting formulation of LP, or to regular human insulin (HR) combined with human NPH insulin (NPH) in this open-label, parallel study. Insulin doses were similar at endpoint. Blood glucose (BG) measurements (before and two hours after meals, bedtime, 3 a.m.)(mmol/l) were lower with LP/NPL two hours after breakfast (8.84 +/- 0.32 vs 10.29 +/- 0.41, p < 0.001), before lunch (6.21 +/- 0.20 vs 7.10 +/- 0.31, p = 0.016), two hours after the evening meal (10.18 +/- 0.36 vs 7.86 +/- 0.28, p < 0.0.001), and at bedtime (7.85 +/- 0.28 vs 9.43 +/- 0.40, p = 001). HbA1c was lower for LP/NPL at endpoint (7.54 +/- 0.11% vs 7.92 +/- 0.10%, p = 0.019). There was no difference in hypoglycaemia or insulin antibody levels. LP/NPL resulted in better glycaemic control than HR/NPH without increasing the risk of hypoglycaemia.
Adolescent↗
Redirection of drug metabolism using antisense technology.
The cytochrome P450 (CYP) family is the most catalytically versatile component of the phase I oxidation metabolic pathway and participates in the metabolism of a large majority of drugs used in clinical practice. The inhibition of specific enzymes of this family can significantly alter the disposition and toxicity of substrate drugs by reducing and/or redirecting their metabolism. This review discusses the approaches available for CYP inhibition, with particular emphasis on the potential use of antisense phosphorodiamidate morpholino oligonucleotide strategies to inhibit human CYP3A4. Inter-individual variations of 10- to 50-fold have been reported in the activity of CYP3A4 enzyme, which contributes to the metabolism of more than half of all clinically relevant drugs. The application of antisense technology for inhibition of specific CYP enzymes can provide significant therapeutic benefits, including: (i) reduction of first-pass drug metabolism; (ii) reduction in drug dosage; (iii) selective reduction of toxic metabolites; and (iv) increased oral/topical drug bioavailability. The use of antisense morpholino oligonucleotide strategies to target CYP enzymes may result in safer and more uniform therapeutic applications.
Amino Acid Sequence↗
Improved postprandial glycemic control with Humalog Mix75/25 after a standard test meal in patients with type 2 diabetes mellitus.
OBJECTIVE: This double-blind study was designed to compare the postprandial glucodynamic profile of Humalog Mix75/25, a new premixed insulin analogue containing 75% neutral protamine lispro and 25% insulin lispro with that of human insulin 70/30 (70% neutral protamine Hagedorn insulin and 30% regular human insulin) in patients with type 2 diabetes mellitus. BACKGROUND: Insulin lispro Mix75/25 (Mix75/25) is the first available insulin formulation in which both the rapid-acting and basal components are insulin analogues. METHODS: This randomized, multicenter, double-blind, crossover study monitored patients' postprandial glucodynamic response to Mix75/25 and human insulin 70/30 (70/30) after a standard test meal. Eighty-four patients with type 2 diabetes participated in this study and were randomly assigned to 1 of 2 treatment sequence groups. Patients received an identical test meal on 4 occasions, completing 2 test meals for each treatment. Equal doses of Mix75/25 or 70/30 were administered 5 minutes before each of the 2 test meals, with doses individualized for each patient. Blood samples were collected for 4 hours after the meal for measurement of plasma glucose. From these plasma glucose measurements, fasting plasma glucose, 2-hour postprandial glucose (2pp), 2-hour postprandial glucose excursion (2pp(ex)), maximum glucose excursion (Gex(max)), the area under the glucose concentration versus time curve from 0 to 4 hours (AUC4), and the area under the glucose excursion versus time curve from 0 to 4 hours (AUCex4) were calculated. RESULTS: Because of significant differences in the baseline fasting plasma glucose levels between Mix75/25 and 70/30 (Mix75/25: 8.9+/-2.2 mmol/L [160.2+/-39.6 mg/dL]; 70/30: 8.6+/-1.9 mmol/L [154+/-34 mg/dL), analyses of the excursion parameters provide a truer comparison of the glucodynamic response between insulin formulations. Mix75/25 resulted in significantly lower values for 2pp(ex) (3.35+/-2.28 vs 4.13+/-2.26 mmol/L), Gex(max) (4.51+/-1.88 vs 5.19+/-1.98 mmol/L), and AUCex4 (8.01+/-7.02 vs 10.6+/-6.47 mmol x h/L) compared with 70/30. CONCLUSIONS: In patients with type 2 diabetes mellitus, premeal injection of Mix75/25 resulted in better postprandial glycemic control than did premeal injection of 70/30 in the 4 hours after a standard meal. Mix75/25 is a valuable option for managing postprandial blood glucose in patients with type 2 diabetes mellitus who require insulin.
Adult↗
Laparoscopic surgical management of giant post-traumatic lymphocele involving sacrum and the lower extremity.
Lymphocele (collection of lymphatic fluid) is not an uncommon occurrence after trauma, surgical or otherwise. It is commonly associated with kidney transplant surgery and trauma to soft tissues of an extensive nature. In this paper, we report the minimally invasive surgical management of an unusual case of a 30-year-old physician who was involved in a road traffic accident as a result of which he received extensive soft tissue injuries to the sacrum, the right buttock, and the right thigh. Over a period of 3 months, he developed a giant lymphocele that defied three attempts at excision and drainage. The patient underwent successful laparoscopic drainage of the collection with ablation of the lining. Video-assisted surgical drainage and ablation is a safe, effective, and minimally invasive procedure that should be put to wider use and can be used to treat very large lesions.
Adult↗
Antisense oligonucleotides targeted to the p53 gene modulate liver regeneration in vivo.
The rapidly proliferating cells of the regenerating liver after partial hepatectomy (PH) present a reproducible in vivo model to study the functional role of the tumor suppressor gene p53. The present study uses the rat 70% PH model along with systemic administration of three different structural types of antisense oligonucleotides (ODNs) designed to suppress p53 expression. We tested the hypothesis that antisense ODNs can inhibit the expression of p53, resulting in the loss of the G(1)-S cell cycle checkpoint and an altered pattern of liver regeneration. Intraperitoneal administration of 5 mg/kg/day antisense phosphorothioate ODN after 70% PH resulted in reduced expression of the p53 protein in the regenerating liver. There were concomitant increases in weight gain of remnant-regenerating liver and expression of proliferating cell nuclear antigen and p21(waf-1) compared with either saline or 5 mg/kg/day mispaired phosphorothioate ODN treatment. Flow cytometric analysis of DNA content of isolated hepatocytes revealed a reduction in the G(0)/G(1) cell population and accumulation of cells with more than 4n DNA in antisense-treated rats. The regenerating livers had significantly diminished cytochrome P-450 (CYP) enzyme activities. Rats treated with p53 antisense ODNs, but not saline or mispair ODN controls, had significantly elevated CYP activities. These observations functionally link the expression of p53 with diminished expression of several CYP isoforms in the liver regeneration model.
Animals↗
c-Myc antisense limits rat liver regeneration and indicates role for c-Myc in regulating cytochrome P-450 3A activity.
Expression of c-myc protein is associated with cell proliferation. The present study uses antisense oligomers to inhibit c-myc expression in the regenerating rat liver after 70% partial hepatectomy (PH). Antisense phosphorodiamidate morpholino oligomers (novel DNA analogs) were administered i.p. immediately after surgery to block expression of c-myc within the first 24 h after PH. A 20-mer PMO complimentary to the c-myc mRNA at the translation start site was an effective sequence (AVI-4126, 5'-ACGTTGAGGGGCATCGTCGC-3'). A single i.p. dose of 0.5 mg/kg AVI-4126 caused reduction of the regenerating liver c-myc protein in a sequence-specific and dose-dependent manner. Inhibition of c-myc expression resulted in reduction of proliferating cell nuclear antigen and arrested cells in the G(0)/G(1) phase of the cell cycle. The ratio of G(2):G(0) cell populations in the regenerating liver 24 h after PH dropped from 29.1 in saline vehicle-treated rats to 18.0 in rats treated with 2.5 mg/kg AVI-4126. The expression of cell cycle checkpoint protein p53 was inhibited with increasing doses of AVI-4126, but expression of p21(waf-1) was unaffected. The activity of cytochrome P-450 3A2 (CYP3A2) was evaluated by immunoblot analysis and erythromycin N-demethylation. AVI-4126 did not alter CYP3A activity in nonhepatectamized animals but showed a dose-dependent decrease in PH rats. We conclude that AVI-4126, antisense oligomer to c-myc, can reduce cell proliferation in the regenerating rat liver. Furthermore, inhibition of c-myc may indirectly influence the expression of CYP3A.
Animals↗
A validated stable isotope dilution liquid chromatography tandem mass spectrometry assay for the trace analysis of cocaine and its major metabolites in plasma.
A validated method has been developed for the simultaneous quantitation of cocaine and its major metabolites (ecgonine methyl ester, benzoylecgonine, and norcocaine) in rat plasma. The method is based upon the use of stable isotope dilution liquid chromatography/atmospheric pressure chemical ionization/tandem mass spectrometry. Previously reported methods do not have the sensitivity and specificity that can be attained with this method. Plasma samples required no cleanup apart from protein precipitation, and no derivatization was required. Selected reaction monitoring was performed on the transitions of m/z 200 to m/z 182 (ecgonine methyl ester), m/z 290 to m/z 168 (benzoylecgonine), m/z 304 to m/z 182 (cocaine), and m/z 290 to m/z 168 (norcocaine). The standard curves were linear over the range from 2 ng/mL (benzoylecgonine, cocaine, and norcocaine) or 5 ng/mL (ecgonine methyl ester) to 1000 ng/mL in rat plasma. The lower limit of quantitation (LLQ) for benzoylecgonine, cocaine, and norcocaine was 2 ng/mL, and for ecgonine methyl ester, the LLQ was 5 ng/mL for plasma. This simple, rapid, reliable, and sensitive method of quantitation had excellent accuracy and precision for the four analytes. The method was sensitive enough to permit a detailed study of the pharmacokinetics of cocaine and its metabolites after administration of a bolus intravenous dose to rats.
Animals↗
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. Mix50 Study Group.
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.
Adult↗