Metformin extended‐release versus immediate‐release: <scp>A</scp>n international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes

Aggarwal, Naresh; Singla, Anuj; Mathieu, Chantal; Montanya, Eduard; Pfeiffer, Andreas F. H.; Johnsson, Eva; Zhao, June; Iqbal, Nayyar; Bailey, Clifford J.

doi:10.1111/dom.13104

Cited by 38 publications

(64 citation statements)

References 11 publications

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“…The results showed that metformin XR was non‐inferior to metformin IR for glycaemic control and not superior to metformin IR for overall gastrointestinal adverse events . Another study also showed that metformin XR demonstrated efficacy and safety similar to that of metformin IR . Although there is no good way to completely avoid the gastrointestinal adverse events associated with metformin, starting with a small dose and gradually increasing the dose may be an effective way to reduce side effects of metformin in elderly patients.…”

Section: Resultsmentioning

confidence: 99%

Comparison of gastrointestinal adverse events with different doses of metformin in the treatment of elderly people with type 2 diabetes

et al. 2019

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What is known and Objective: Gastrointestinal discomfort is the most common adverse event of metformin treatment for type 2 diabetes, especially in elderly patients.The aim of this study was to compare gastrointestinal adverse events resulting from different doses of metformin used for the treatment of elderly people with type 2 diabetes.Methods: A total of 361 elderly patients with newly diagnosed diabetes were randomly divided into three groups: metformin 1000 mg/d (N = 120), metformin 1500 mg/d (N = 121) and metformin 2000 mg/d (N = 120). Glycaemic control and gastrointestinal adverse events (abdominal pain, diarrhoea, nausea, vomiting, bloating and anorexia) were assessed and compared among the three groups after 12 weeks of treatment.Results and discussion: At baseline, there was no significant difference in gastrointestinal symptoms among the three groups. After 12 weeks of treatment with metformin, the change in HbA 1c level was −0.7%, −0.9% and −1.0% for the 1000 mg/d, 1500 mg/d and 2000 mg/d groups, respectively (P < .0001). There was no significant difference in gastrointestinal adverse events among the three groups after treatment with metformin. In total, 62 people (17.2%) could not tolerate the adverse effects of metformin, and most of them stopped treatment in the first 4 weeks. Logistic regression analysis shows that female sex (OR = 2.660, 95%CI 1.692-4.183, P < .0001) and the concurrent use of organic cation transporter 1-inhibiting drugs (OR = 1.874, 95%CI 1.076-3.265, P = .027) are independent risk factors for adverse events. What is new and conclusions:Our data demonstrate that metformin doses of 1000 mg/d-2000 mg/d have similar adverse events but that 2000 mg/d of metformin yields the best glycaemic control in elderly people with diabetes. If elderly people can tolerate 1000 mg/d of metformin, we could gradually increase the dose to 2000 mg/d to achieve better glycaemic control. K E Y W O R D S elderly, gastrointestinal adverse events, metformin, type 2 diabetes | 471 YUXIN et al.

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Section: Resultsmentioning

confidence: 99%

Comparison of gastrointestinal adverse events with different doses of metformin in the treatment of elderly people with type 2 diabetes

et al. 2019

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“…Additionally, a higher C max is not expected to per se worsen metformin tolerability while maintaining similar pharmacodynamic effect. In a study by Aggarwal et al, 10 metformin extended release resulted in higher C max than metformin immediate release but had better gastrointestinal tolerability at the same total daily dose. Food decreases C max of metformin by 40% and AUC by 25%.…”

Section: Discussionmentioning

confidence: 98%

Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open‐Label, Placebo‐Controlled, Crossover Study

Khedkar

Fleming²,

Cherrington

et al. 2019

Clinical Translational Sci

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Oral insulin tregopil ( IN ‐105; a new drug under development) may be coadministered with oral antidiabetic drugs, such as metformin in patients with type 2 diabetes mellitus for optimal glycemic control. IN ‐105 has sodium caprate excipient, a permeation enhancer, for enhancing absorption in the stomach and increasing bioavailability via an oral route. Sodium caprate may increase bioavailability of metformin by a similar mechanism. Therefore, it was necessary to study the effect of IN ‐105 on pharmacokinetics (PKs) of metformin. In this randomized, open‐label, cross‐over study, metformin was administered to healthy volunteers receiving IN ‐105/placebo under fed/fasting conditions. The 90% confidence interval ( CI ) of the geometric mean ratio of the area under the curve from time zero to infinity ( AUC 0‐inf ; fasting and fed) and peak plasma concentration (C max ; fed) of metformin were within 0.80–1.25 acceptance range. Under fasting conditions, the upper bound margin of C max was just beyond this range (i.e., 1.27) and was concluded as functionally not relevant. There was no clinically significant effect of sodium caprate/ IN ‐105 on PKs of metformin under fasting/fed conditions, and it was safe.

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“…В международном рандомизированном двойном слепом исследовании у 568 лиц с СД 2 типа N. Aggarwal еt al. [72] проводили сравнение эффективности и безопасности метформина XR и метформина IR, продолжительность периода наблюдения составила 24 нед. Метформин XR, имея преимущество дозирования 1 раз в сутки, в целом продемонстрировал равную метформину IR эффективность.…”

Section: A R T I C L E I N P R E S Sunclassified

Hypoglycemia and the risk of cognitive impairment and dementia in elderly and senile patients with type 2 diabetes

Остроумова¹,

Суркова²,

Васильевна³

et al. 2020

Diabetes mellitus

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Research results show that poor glycemic control and recurrent episodes of severe hypoglycaemia are associated with a decrease in cognitive function in elderly people with type 2 diabetes mellitus (T2DM). On the other hand, patients with diabetes mellitus associated with cognitive impairment/dementia are most at risk of developing hypoglycaemic conditions. It is obvious that the relationship between hypoglycaemia and dementia is very complex and has a mutually aggravating nature. Studies also show that individuals of older age groups with diabetes and cognitive impairment have a high risk of developing hypoglycaemic conditions, such as unwanted side effects from glucose-lowering therapy. In this case, of particular interest is the question that is being actively studied at the present time, which is concerning the effect of different groups of glucose-lowering antidiabetic drugs on the cognitive status and the rate of cognitive decline in diabetic patients with cognitive impairment. In this review, we attempted to summarise, systematise, and present data available in the literature concerning the effect of hypoglycaemia on the risk of cognitive impairment and dementia in elderly and senile patients with type-2 diabetes, as well as the degree of participation in this process of of various groups of sugar-lowering antidiabetic drugs.

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Metformin extended‐release versus immediate‐release: An international, randomized, double‐blind, head‐to‐head trial in pharmacotherapy‐naïve patients with type 2 diabetes

Cited by 38 publications

References 11 publications

Comparison of gastrointestinal adverse events with different doses of metformin in the treatment of elderly people with type 2 diabetes

Comparison of gastrointestinal adverse events with different doses of metformin in the treatment of elderly people with type 2 diabetes

Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open‐Label, Placebo‐Controlled, Crossover Study

Hypoglycemia and the risk of cognitive impairment and dementia in elderly and senile patients with type 2 diabetes

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