A randomized, open‐label, multicentre, parallel‐controlled study comparing the efficacy and safety of biphasic insulin aspart 30 plus metformin with biphasic insulin aspart 30 monotherapy for type 2 diabetes patients inadequately controlled with oral antidiabetic drugs: The merit study

Guo, Lixin; Chen, Li; Chang, Baocheng; Yang, Liyong; Liu, Yu; Feng, Bo

doi:10.1111/dom.13454

“…Metformin(Met) is the first-line drug for the treatment of T2DM and plays an anti-hyperglycemic role mainly by inhibiting liver glucose through AMPK-dependent or -independent pathways (11)(12)(13)(14). The Chinese MERIT study showed that premixed insulin combined with Met resulted in a greater reduction in HbA1c, less insulin consumption, less weight gain, a lower incidence of hypoglycemia, and lower cardiovascular risk than premixed insulin alone (15)(16)(17).…”

Section: Introductionmentioning

confidence: 99%

Effects of mulberry twig alkaloids(Sangzhi alkaloids) and metformin on blood glucose fluctuations in combination with premixed insulin-treated patients with type 2 diabetes

Meng,

Xu,

Liu

et al. 2023

Front. Endocrinol.

1

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IntroductionWe aimed to evaluated the effect of premixed insulin (Ins), premixed insulin combined with metformin (Ins+Met) or mulberry twig alkaloids(Ins+SZ-A) on blood glucose fluctuations in patients with type 2 diabetes (T2DM) using continuous glucose monitors (CGM).MethodsThirty patients with T2DM and poor blood glucose control using drugs were evaluated for eligibility during the screening period. Subsequently, their original hypoglycemic drugs were discontinued during the lead-in period, and after receiving Ins intensive treatment for 2 weeks, they were randomly assigned to receive either Ins, Ins+Met, or Ins+SZ-A treatment for the following 12 weeks. The main efficacy endpoint comprised changes in their CGM indicators changes (mean blood glucose level [MBG], standard deviation of blood glucose [SDBG], mean amplitude of glycemic excursions [MAGE], postprandial glucose excursions [PPGE], the largest amplitude of glycemic excursions [LAGE], mean of daily difference [MODD], time in range between 3.9–10.0 mmol/L [TIR] and area under the curve for each meal [AUCpp]) during the screening, lead-in, and after 12-week treatment period. Changes in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), 1-h postprandial blood glucose (1h-PBG), 2-h postprandial blood glucose (2h-PBG), fasting blood lipids and postprandial blood lipids were also measured at baseline and after 12 weeks of treatmentResultsThe CGM indicators of the three groups during the lead-in period all showed significant improvements compared to the screening period (P<0.05). Compared with those in the lead-in period, all of the CGM indicators improved in the the Ins+Met and Ins+SZ-A groups after 12 weeks of treatment (P<0.05), except for MODD. After 12-week treatment, compared with the Ins group, Ins+Met and Ins+SZ-A groups showed improved MBG, SDBG, TIR, breakfast AUCpp,lunch AUCpp, HbA1c, FBG, 1h-PBG, fasting blood lipid and postprandial blood lipid indicators (P<0.05). Further, the LAGE, PPGE, MAGE, dinner AUCpp and 2h-PBG levels of the Ins+SZ-A group were significantly lower than those of the Ins+Met and Ins groups (P<0.05).ConclusionOur findings highlight the efficacy of combination therapy (Ins+SZ-A or Ins+Met) in improving blood glucose fluctuations, as well as blood glucose and lipid levels. Ins+SZ-A reduces postprandial blood glucose fluctuations more than Ins+Met and Ins groups.Trial registration numberISRCTN20835488.

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Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis

Guo

¹

,

Chang

²

,

Chen

³

et al. 2021

Sci Rep

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We assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into “low” and “high” risk subgroups based on their GloboRisk scores and into “BMI ≤ 26 kg/m2”and “BMI > 26 kg/m2” subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m2, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.

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Comparative Analysis of Clinical Effects of Insulin Aspart Combined with Acarbose and Metformin in the Treatment of Diabetes Mellitus

Jin¹,

Zhang²

2022

Evidence-Based Complementary and Alternative Medicine

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Objective. To investigate the clinical effect of Insulin aspart 30 combined with acarbose and metformin enteric-coated tablets in the treatment of diabetes mellitus. Methods. 90 diabetic patients admitted to our hospital from January 2019 to December 2021 were selected as the research subjects, and the patients were randomly divided into group A (n = 30, using insulin aspart 30 alone), group B (n = 30, using insulin aspart 30 combined with metformin enteric-coated tablets), and group C (n = 30, using insulin aspart 30 combined with acarbose). The blood glucose balance before meals and before going to bed was maintained in the three groups of patients, and the blood glucose fluctuations, time to target, hypoglycemia, insulin dosage, and daily consumption of the three groups were compared. Results. There was no significant difference in blood glucose and average blood glucose at each time point before treatment in the 3 groups of patients ( P > 0.05 ); compared with the blood glucose and average blood glucose at each time point after reaching the target in the three groups, the blood glucose after dinner in group A was significantly higher than that in groups B and C; at 2 : 00, the blood glucose of group A was significantly higher than that of group B ( P < 0.05 ); there was no significant difference in blood glucose and average blood glucose at other time points ( P > 0.05 ). There was no significant difference in blood glucose standard deviation, LAGE, and PPGE at each point in the three groups before treatment ( P > 0.05 ); the standard deviation of blood glucose, LAGE, and PPGE at each point of the three groups of patients after reaching the standard were compared with those in the same group before treatment, and the differences were statistically significant ( P < 0.05 ); there were statistically significant differences in blood glucose standard deviation, LAGE, and PPGE among the 3 groups after reaching the standard ( P < 0.05 ). Compared among the three groups, the standard deviation of blood glucose and LAGE level at each point after reaching the standard, the difference between group B, group C, and group A was statistically significant ( P < 0.05 ); however, there was no significant difference between the patients in group B and group C ( P > 0.05 ); the level of PPGE in group A was higher than that in group B, which was higher than group C, and between group C and group A, the difference was statistically significant ( P < 0.05 ). The time of reaching the standard in 3 groups was statistically significant ( P < 0.05 ); there was no significant difference in the time of reaching the standard between group B and group C ( P > 0.05 ). There was no significant difference in the incidence of hypoglycemia among the 3 groups ( P > 0.05 ); there were significant differences in the proportion of insulin twice a day among the three groups ( P < 0.05 ); there were statistically significant differences in daily insulin dosage among the 3 groups after reaching the standard ( P < 0.05 ). The daily consumption of the three groups of patients after reaching the standard was compared, the difference was statistically significant ( P < 0.05 ), and there was no significant difference between group A and group B ( P > 0.05 ). Conclusion. The effect of insulin aspart 30 alone in the treatment of diabetic patients is not good, it will lead to a large fluctuation of blood sugar in the patient’s body, and the time required to reach the standard is relatively long; the use of insulin aspart 30 combined with metformin enteric-coated tablets or acarbose can effectively reduce the blood sugar fluctuation range of diabetic patients and reduce the number of insulin injections, and insulin aspart 30 combined with metformin en teric-coated tablets can also greatly reduce the daily insulin dosage and daily consumption cost of diabetic patients.

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A randomized, open‐label, multicentre, parallel‐controlled study comparing the efficacy and safety of biphasic insulin aspart 30 plus metformin with biphasic insulin aspart 30 monotherapy for type 2 diabetes patients inadequately controlled with oral antidiabetic drugs: The merit study

Abstract: BIAsp 30 plus metformin was non-inferior to BIAsp 30 in safely reducing HbA1c in this study.

Cited by 3 publications

References 27 publications

Effects of mulberry twig alkaloids(Sangzhi alkaloids) and metformin on blood glucose fluctuations in combination with premixed insulin-treated patients with type 2 diabetes

Effects of mulberry twig alkaloids(Sangzhi alkaloids) and metformin on blood glucose fluctuations in combination with premixed insulin-treated patients with type 2 diabetes

Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis

Comparative Analysis of Clinical Effects of Insulin Aspart Combined with Acarbose and Metformin in the Treatment of Diabetes Mellitus

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