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Pharmacokinetics and pharmacodynamics of insulin glargine-insulin glulisine basal-bolus and twice-daily premixed analog insulin in type 1 diabetes mellitus patients during three standardized meals.

ABSTRACT: Aims:To evaluate the pharmacokinetics and pharmacodynamics of basal insulin glargine with mealtime insulin glulisine or twice daily 75/25 premixed neutral protamine insulin lispro and insulin lispro in individuals with type 1 diabetes during three standardized meals over a 24 hour duration and compare to physiologic insulin and glucose responses in healthy non-diabetic individuals. Methods:Twelve healthy (4 male/8 female) and thirteen individuals with type 1 diabetes (8 male/5 female) were studied during three sequential standardized meals. Individuals with type 1 diabetes received either glargine and glulisine injected 5 minutes subcutaneously before each meal or premixed insulin lispro injected 5 minutes before breakfast and dinner in a randomized fashion separated by eight weeks. Results:The incremental systemic insulin AUC, maximal insulin concentration, and rate of rise of systemic insulin (0-30 minutes) during all three meal intervals were similar between glargine/glulisine and healthy controls. Incremental glucose AUC with glargine/glulisine was similar to controls at lunch and dinner. With premix 75/25 insulin, insulin AUC was lower and incremental glucose AUC was greater at lunch compared to the healthy and glargine/glulisine. Hypoglycemic events before lunch were greater with premix insulin group than with glargine/glulisine (p?

SUBMITTER: Lamos EM

PROVIDER: S-EPMC5680437 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

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Pharmacokinetics and pharmacodynamics of insulin glargine-insulin glulisine basal-bolus and twice-daily premixed analog insulin in type 1 diabetes mellitus patients during three standardized meals.

Lamos Elizabeth Mary EM Younk Lisa M LM Tate Donna B DB Davis Stephen N SN

Journal of clinical & translational endocrinology 20151224

<h4>Aims</h4>To evaluate the pharmacokinetics and pharmacodynamics of basal insulin glargine with mealtime insulin glulisine or twice daily 75/25 premixed neutral protamine insulin lispro and insulin lispro in individuals with type 1 diabetes during three standardized meals over a 24 hour duration and compare to physiologic insulin and glucose responses in healthy non-diabetic individuals.<h4>Methods</h4>Twelve healthy (4 male/8 female) and thirteen individuals with type 1 diabetes (8 male/5 fem ...[more]

PMID: 29159123

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Project description:INTRODUCTION:OPTIMIZE evaluated the efficacy, safety and treatment satisfaction of insulin glargine 300 U/mL once daily (Gla-300 OD) in people with type 1 diabetes mellitus (T1DM) previously uncontrolled on basal insulin twice daily (BID) as part of basal-bolus therapy. METHODS:OPTIMIZE was a 28-week, prospective, interventional, single-arm phase 4 trial in adults with T1DM. At baseline, basal insulin BID treatment was switched to Gla-300 OD titrated to a fasting self-monitored blood glucose target of 4.4-7.2 mmol/L (80-130 mg/dL). The primary endpoint was the mean glycated haemoglobin (HbA1c) change from baseline to week 24. Secondary endpoints included self-monitored blood glucose, fasting-plasma glucose, hypoglycaemia and patient-reported outcomes including the Diabetes Treatment Satisfaction Questionnaire status version (DTSQs). RESULTS:Switching to Gla-300 OD significantly improved mean HbA1c (8.54% at baseline and 8.27% at week 24 [last observation carried forward, N = 94, p < 0.0001]; mean difference 0.27% [95% CI 0.15, 0.40]). There was a statistically significant decrease in fasting self-monitored blood glucose during the study (analysis of variance for repeated measures, p = 0.014; N = 72). Eight-point self-monitored blood glucose was significantly improved between baseline and week 24 for post-breakfast (p = 0.009), post-dinner (p = 0.009) and bedtime (p = 0.049) values. The study did not allow for any significant effects on confirmed and/or severe hypoglycaemia at the ≤ 3.9 mmol/L [≤ 70 mg/dL] or < 3.0 mmol/L [< 54 mg/dL] blood glucose cut-offs to be observed. Statistically significant improvements were observed in DTSQs total scores from baseline (24.1) to week 24 (29.4, p < 0.0001). CONCLUSIONS:A basal-bolus regimen including Gla-300 OD was associated with improvements in HbA1c and treatment satisfaction in people with uncontrolled T1DM previously receiving basal-bolus insulin including a basal insulin BID analogue. TRIAL REGISTRATION:EudraCT number: 2015-001186-46.

Project description:IntroductionIdentification of subgroups of patients that may benefit most from certain treatment is important because individual treatment response varies due to multiple contributing factors. The present study used the subgroup identification based on the differential effect search (SIDES) algorithm to identify subgroups with different treatment responses to insulin intensification therapies.MethodsThis was a post hoc analysis of a 24-week, multicenter, open-label, randomized, parallel study comparing prandial premixed therapy (PPT) to basal-bolus therapy (BBT). Patients with type 2 diabetes mellitus were randomized to PPT (insulin lispro mix 50/50 thrice daily with meals) or BBT (glargine at bedtime plus mealtime insulin lispro) insulin intensification therapies. The SIDES algorithm was used to identify the subgroups from at-goal patients [glycated hemoglobin (HbA1c) <7.0% (53.0 mmol/mol) at the end of 24 weeks; n = 182] who could have benefitted from insulin intensification therapies.ResultsBaseline characteristics of overall at-goal patients were comparable between PPT and BBT groups. The SIDES algorithm identified patients with race other than Caucasian (i.e., African-American, Asian, and Hispanic) and baseline fasting blood glucose (FBG) <8.89 mmol/L as a subgroup that could respond better to PPT relative to BBT than the overall at-goal patient population. In this identified subgroup population, the HbA1c mean (standard deviation) changes from baseline to endpoint in PPT and BBT groups were -2.27 (0.88)% versus -2.05 (0.75)%; p = 0.40, respectively; while in the overall at-goal patients, the HbA1c changes were -2.17 (0.79)% versus -2.34 (1.00)%; p = 0.19, respectively.ConclusionsThe preliminary results showed that the subgroup of patients with race other than Caucasian and FBG <8.89 mmol/L may respond better to premixed intensification therapy. This result provides some preliminary information for further investigation in prospective studies.FundingEli Lilly and Company.Clinical trial registrationClinicaltrials.gov ID number: NCT00110370.

Project description:AimsA variety of basal insulin preparations are used to treat patients with type 2 diabetes mellitus (T2DM). We aimed to summarize scientific evidence on relative efficacy and safety of insulin glargine (IGlar) and other insulins in T2DM.MethodsA systematic review was carried out in major medical databases up to December 2012. Relevant studies compared efficacy and safety of IGlar, added to oral drugs (OAD) or/and in combination with bolus insulin, with protamine insulin (NPH) or premixed insulin (MIX) in the same regimen, as well as with insulin detemir (IDet), in T2DM. Target HbA1c level without hypoglycemic events was considered the primary endpoint.ResultsTwenty eight RCTs involving 12,669 T2DM patients followed for 12-52 weeks were included in quantitative analysis. IGlar + OAD use was associated with higher probability of reaching target HbA1c level without hypoglycemia as compared to NPH + OAD (RR = 1.32 [1.09, 1.59]) or MIX without OAD (RR = 1.61 [1.22, 2.13]) and similar effect as IDet + OAD (RR = 1.07 [0.87, 1.33]) and MIX + OAD (RR = 1.09 [0.86, 1.38]). IGlar + OAD demonstrated significantly lower risk of symptomatic hypoglycemia as compared to NPH + OAD (RR = 0.89 [0.83, 0.96]), MIX + OAD (RR = 0.75 [0.68, 0.83]) and MIX without OAD(RR = 0.75 [0.68, 0.83]), but not with IDet + OAD (RR = 0.99 [0.90, 1.08]). In basal-bolus regimens, IGlar demonstrated similar proportion of T2DM patients achieving target HbA1c as compared to NPH (RR = 1.14 [0.91, 1.44]) but higher than MIX (RR = 1.26 [1.12, 1.42) or IDet (RR = 1.38 [1.11, 1.72]). The risk of severe hypoglycemia was lower in IGlar than in NPH (RR = 0.77 [0.63, 0.94]), with no differences in comparison with MIX (RR = 0.74 [0.46, 1.20]) and IDet (RR = 1.10 [0.54, 2.25]). IGlar + OAD has comparable safety profile to NPH, with less frequent adverse events leading to treatment discontinuation than MIX + OAD (RR = 0.41 [0.22, 0.76]) and IDet + OAD (RR = 0.40 [0.24, 0.69]). Also severe adverse reactions were less common for IGlar + OAD when compared to MIX + OAD (RR = 0.71 [0.52; 0.98]).ConclusionFor the majority of examined efficacy and safety outcomes, IGlar use in T2DM patients was superior or non-inferior to the alternative insulin treatment options.

Dataset Information

Pharmacokinetics and pharmacodynamics of insulin glargine-insulin glulisine basal-bolus and twice-daily premixed analog insulin in type 1 diabetes mellitus patients during three standardized meals.

Publications

Pharmacokinetics and pharmacodynamics of insulin glargine-insulin glulisine basal-bolus and twice-daily premixed analog insulin in type 1 diabetes mellitus patients during three standardized meals.

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