The optimal morning:evening ratio in total dose of twice‐daily biphasic insulin analogue in poorly controlled Type 2 diabetes: a 24‐week multi‐centre prospective, randomized controlled, open‐labelled clinical study

Jung, Chang Hee; Park, J.-Y.; Cho, J. H.; Yoon, Kun Ho; Yang, Hae Kyung; Lee, Young-Ho; Soo, Bong; Lee, B.-W.

doi:10.1111/dme.12322

Cited by 5 publications

(17 citation statements)

References 23 publications

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“…Of these #bib165 were duplicates and 356 were excluded. Three additional studies were identified (including two that had been submitted, but not published at the time of the literature search); hence 18 studies from the literature were included in the review. Three eligible studies were identified in the search of ClinicalTrials.gov and included.…”

Section: Resultsmentioning

confidence: 99%

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Efficacy and safety of premixed insulin analogs in Asian patients with type 2 diabetes: A systematic review

Sheu

Lee

et al. 2017

J of Diabetes Invest

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Aims/IntroductionThe primary aim of this systematic review was to provide an overview of the efficacy and safety of premixed insulin analogs in Asians, specifically East Asians, with type 2 diabetes.Material and MethodsThe MEDLINE, Embase, Cochrane Library and ClinicalTrials.gov databases were searched from 1 January 1995 to 26 November 2015. Randomized controlled trials involving East Asians with type 2 diabetes treated with any premixed insulin analog were included. Major comparator treatments were basal insulin and basal–bolus insulin. Comparisons were also made between East Asian and Caucasian patients. The primary efficacy outcome was glycated hemoglobin change from baseline to end‐point. The primary safety outcome was the incidence of hypoglycemia.ResultsA total of 21 studies were included; most (n = 14) were carried out in China or Japan. The duration of treatment ranged from 12 to 48 weeks. The glycated hemoglobin mean/least squares mean change from baseline to end‐point after treatment with premixed insulin analogs ranged from −0.12 to −4.2% (improvement was generally more pronounced with insulin initiation vs intensification). The incidence of hypoglycemia ranged from 8.3 to 72.0% in most studies, with the variability reflecting the definition of hypoglycemia used. Efficacy and safety outcomes for premixed insulin analogs were generally similar to those for basal or basal–bolus insulin. Limited evidence suggests that dosing, efficacy and safety profiles might differ slightly between East Asian and Caucasians receiving premixed insulin analogs.ConclusionsThese results support the current use of premixed insulin analogs for managing East Asian patients with type 2 diabetes.

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Section: Resultsmentioning

confidence: 99%

“…Most studies (n = 15) [15][16][17][21][22][23]25,27,[29][30][31][32][33][34][35] included patients with a minimum HbA1c of ≥7.0 or ≥7.5% (Table 1). One study 18 included patients on the basis of FPG and postprandial plasma glucose concentrations (≥7 and ≥11.1 mmol/L, respectively).…”

Section: Study Characteristicsmentioning

confidence: 99%

Efficacy and safety of premixed insulin analogs in Asian patients with type 2 diabetes: A systematic review

Sheu

Lee

et al. 2017

J of Diabetes Invest

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“…These patients were randomly assigned to a long-acting insulin analogue and biphasic insulin analogue, or were switched from OHAs to twice-daily of premixed insulin lispro 25 or premixed insulin aspart protamine 30 121415. All patients were followed up in October 2014 at Severance Diabetes Center, Seoul, South Korea.…”

Section: Methodsmentioning

confidence: 99%

“…A standardized mixed meal (Ensure, Meiji Dairies Corporation, Tokyo, Japan; total 500 kcal, 17.5 g fat, 68.5 g carbohydrate, and 17.5 g protein) stimulation test was conducted after an 8-hour overnight fast, and postprandial glucose and C-peptide were measured at 90 minutes in 33.1% of subjects. In the rest of 66.9% of subjects, postprandial glucose and serum were measured 2 hours after each subject's conventional diet 121415…”

Section: Methodsmentioning

confidence: 99%

“…Previously, we investigated the stage at which both physicians and patients agreed to start insulin therapy, and what are acceptable HbA1c levels for Korean subjects with T2D in real practice 11. We have also tried to answer questions regarding the characteristics of patients who respond adequately to basal plus insulin or to insulin analogues (basal or biphasic insulin analogue) after sulfonylurea failure,1213 as well as the optimal dosing ratio of twice-daily biphasic insulin analogues 1415. However, little research has been performed on whether a change in therapeutic strategy from insulin therapy to OHAs could be successfully applied and, if so, which characteristics are predictive of successful maintenance on OHAs after switching from initial insulin therapy in patients with T2D, especially in the Korean population.…”

Section: Introductionmentioning

confidence: 99%

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Characteristics Predictive for a Successful Switch from Insulin Analogue Therapy to Oral Hypoglycemic Agents in Patients with Type 2 Diabetes

et al. 2016

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PurposeThe objective of this study was to investigate clinical and laboratory parameters that could predict which patients could maintain adequate glycemic control after switching from initial insulin therapy to oral hypoglycemic agents (OHAs) among patients with type 2 diabetes (T2D).Materials and MethodsWe recruited 275 patients with T2D who had been registered in 3 cohorts of initiated insulin therapy and followed up for 33 months. The participants were divided into 2 groups according to whether they switched from insulin to OHAs (Group I) or not (Group II), and Group I was further classified into 2 sub-groups: maintenance on OHAs (Group IA) or resumption of insulin (Group IB).ResultsOf 275 patients with insulin initiation, 63% switched to OHAs (Group I) and 37% continued insulin (Group II). Of these, 44% were in Group IA and 19% in Group IB. The lowest tertile of baseline postprandial C-peptide-to-glucose ratio (PCGR), higher insulin dose at switching to OHAs, and higher HbA1c level at 6 months after switching to OHAs were all associated with OHA failure (Group IB; p=0.001, 0.046, and 0.014, respectively). The lowest tertile of PCGR was associated with ultimate use of insulin (Group IB and Group II; p=0.029).ConclusionHigher baseline level of PCGR and lower HbA1c levels at 6 months after switching to OHAs may be strong predictors for the successful maintenance of OHAs after switching from insulin therapy in Korean patients with T2D.

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Circadian Variation in Efficacy of Medications

Walton

Walker

Bumgarner

et al. 2020

Clin Pharma and Therapeutics

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Although much has been learned about circadian clocks and rhythms over the past few decades, translation of this foundational science underlying the temporal regulation of physiology and behavior to clinical applications has been slow. Indeed, acceptance of the modern study of circadian rhythms has been blunted because the phenomenology of cyclic changes had to counteract the 20th century dogma of homeostasis in the biological sciences and medicine. We are providing this review of clinical data to highlight the emerging awareness of circadian variation in efficacy of medications for physicians, clinicians, and pharmacists. We are suggesting that gold‐standard double‐blind clinical studies should be conducted to determine the best time of day for optimal effectiveness of medications; also, we suggest that time of day should be tracked and reported as an important biological variable in ongoing clinical studies hereafter. Furthermore, we emphasize that time of day is, and should be considered, a key biological variable in research design similar to sex. In common with biomedical research data that have been historically strongly skewed toward the male sex, most pharmaceutical data have been skewed toward morning dosing without strong evidence that this is the optimal time of efficacy.

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The optimal morning:evening ratio in total dose of twice‐daily biphasic insulin analogue in poorly controlled Type 2 diabetes: a 24‐week multi‐centre prospective, randomized controlled, open‐labelled clinical study

Abstract: These results indicate that initiating twice-daily biphasic insulin analogue on regimens with a higher dose before breakfast than before dinner (i.e. ratio approximately 55:45 to 60:40) might be more appropriate in Korean subjects with Type 2 diabetes.

Cited by 5 publications

References 23 publications

Efficacy and safety of premixed insulin analogs in Asian patients with type 2 diabetes: A systematic review

Efficacy and safety of premixed insulin analogs in Asian patients with type 2 diabetes: A systematic review

Characteristics Predictive for a Successful Switch from Insulin Analogue Therapy to Oral Hypoglycemic Agents in Patients with Type 2 Diabetes

Circadian Variation in Efficacy of Medications

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